Plantar Fasciitis Treatments

Number: 0235

Policy

Aetna considers endoscopic plantar fasciotomy medically necessary as an alternative to conventional open plantar fasciotomy for members with intractable plantar fasciitis or heel spur syndrome who have failed a 6-month trial of conservative therapy.

Aetna considers extracorporeal shock-wave therapy (ESWT) with the OssaTron (HealthTronics, Marietta, GA), the Dornier Epos Ultra (Dornier Medical Systems, Kennesaw, GA), the Sonocur (Siemens Medical Solutions Inc., Iselin, NJ), the Orbasone Pain Relief System (Orthometrix, Inc., White Plains, NY), the Orthospec Extracorporeal Shock Wave Therapy (Medispec, Ltd., Germantown, MD), or any other ESWT devices, alone or in combination with dry needling, experimental and investigational for plantar fasciitis because their effectiveness has not been established. 

Aetna considers the following approaches (not an all-inclusive list) experimental and investigational for members with plantar fasciitis because there is a lack of reliable published literature documenting the safety and efficacy of these techniques in the treatment of plantar fasciitis:

• ActiveMatrix
• Acupuncture
• Autologous blood/growth factor injection
• Botulinum toxin
• Coblation therapy (eg, Topaz MicroDebrider)
• Cryo-preserved human amniotic membrane injection
• Cryosurgery (cryotherapy)
• Gastrocnemius lengthening surgery (e.g., gastrocnemius recession)
• Graston technique (instrument-assisted soft-tissue mobilization)
• Intracorporeal pneumatic shock therapy
• Kinesio taping/elastic therapeutic taping
• Light emitting diode
• Local ozone (O2-O3) injection
• Low-level laser therapy
• Marrow stimulation techniques (microfracture, drilling)
• Micronized dehydrated amniotic/chorionic membrane allograft
• Neural therapy (injection of local anesthetics)
• Piezoelectric focal waves application
• Plantar fascia partial release guided by ultrasonic energy
• Platelet rich plasma/platelet-poor plasma/growth factor injection
• Pulsed radiofrequency electromagnetic field therapy
• Radiofrequency (pulsed or thermal) lesioning
• Radiotherapy
• The TENEX procedure (ultrasound-guided percutaneous fasciotomy/tenotomy)
• The TenJet system
• Transcranial direct current stimulation
• Trigger point dry needling
• Ultrasound therapy.

Notes: Heel cushions/pads, night splints, shoe modifications, or orthopedic shoes for plantar fasciitis are not covered under plans that exclude orthopedic shoes, foot orthotics, and other supportive devices of the feet.  Members should refer to their benefit plan documents for applicable terms and conditions. 

Background

Plantar fasciitis is defined as the traction degeneration of the plantar fascia at its origin on the heel.  Plantar fasciitis is the most common cause of chronic heel pain.  It is usually caused by bone spurs or inflammation of the foot's connective tissue and the condition may be resistant to conservative treatment.  Conservative treatments for plantar fasciitis include rest, physical therapy, heel cushions, non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, taping, foot orthotics (2nd line conservative treatment), shoe modifications, night splinting, and casting.

Surgical intervention may be indicated for patients who fail conservative treatment.  Well-designed placebo- or sham-controlled clinical trials for plantar fasciitis are especially important because:

1. most cases of plantar fascial pain resolve spontaneously over time; and
2. pain is a symptom that is especially susceptible to placebo effects.

Radiofrequency lesioning is used to ablate pain pathways and is generally employed for intractable pain that has not responded to conservative measures.  Radiofrequency lesioning is not an established procedure for the treatment of plantar fasciitis.

Most recently, extracorporeal shock wave therapy (ESWT) has been used to treat plantar fasciitis.  Extracorporeal shock wave therapy is thought to relieve pain by disrupting scar tissue, causing microscopic damage to that tissue.  This induces new blood vessel formation into the injured area and facilitates the healing process.

The Dornier EPOS Ultra is an ESWT system that uses electromagnetic energy to generate a shock wave, which travels through a water-filled coupling cushion mounted to a therapy head.  The therapy head has an acoustic lens to focus the shock wave treatment on the target tissue.  The EPOS Ultra also has an ultrasound imaging system that is used to observe and monitor the shock wave treatment.  Typically, 3,800 shock waves are delivered over 20 mins.

In support of their pre-market approval application (PMA), a randomized, double-blind, sham-treatment-controlled study was conducted involving 150 adult patients with chronic plantar fasciitis enrolled at 6 clinical centers.  Patients had at least moderate pain (visual analog score [VAS] greater than 5) for at least 6 months and a history of prior conservative therapy (including NSAIDs and 2 other conservative therapies).  After being randomized to active or sham treatment groups, patients underwent a single ESWT session, and were followed for 12 months.  After 3 months, patients who received sham treatment were offered active unmasked treatment.  To maintain physician blinding during the first 3 months of the study, the treatment was administered by a physician who did not perform the follow-up evaluations.

Although there was a modest, statistically significant difference in improvement in VAS pain scores from baseline (the primary study endpoint) between active and sham treatment groups at 3 months, this was not accompanied by a significant improvement of function.  In the active group, the pain score decreased by an average of 56.5 % by the end of 3 months; in the sham group, the average pain score decreased by 46.6 %.  Patients in the active group were more likely (56 %) than patients in the sham group (45 %) to report an improvement in VAS pain scores of 60 % or more from baseline; however, this difference was not statistically significant.  There was a statistically significant difference in patient satisfaction (Roles and Maudsley pain scores) between treatment groups, with 62 % of active patients with good to excellent results, compared to 40 % of sham patients.  However, there was no statistically significant difference between active and placebo groups with respect to function (American Orthopaedic Foot and Ankle Society [AOFAS] Ankle-Hindfoot Scale (a validated rating scale which incorporates assessment of function (50 %), pain (40 %), and alignment (10 %)).  There was also no statistically significant difference between active and placebo treated groups with respect to a measure of general health status (SF12 Health Status Questionnaire (patient's self-assessment of general health status and mental condition)).

The most common complication was pain during treatment, which occurred in 72.4 % of active patients and 6.8 % of sham patients.  The investigators assessed the likelihood that patient blinding was maintained during the study, given difference in treatment-induced pain between active and sham treatments.  After the ESWT session, the investigators asked patients in each treatment group whether they experienced pain during treatment, and had them guess as to whether they had been assigned to active or sham treatment.  Sixty percent of patients in the active group correctly guessed that they received active treatment, and 40 % were unsure.  In the sham group, 15 % of patients correctly guessed that they received sham treatment, and 85 % believed that they received an active treatment or were unsure.  Active patients who reported pain during treatment were more likely to have correctly guessed their assignment than active patients who reported no pain; however, there was no significant difference at follow-up in change in VAS score from baseline between active patients who believed they received active treatment and active patients who believed they received a sham treatment.

Other complications included pain 3 to 5 days after treatment, which was reported in 41 % of patients in the active group; however, there was no statistically significant difference between active and sham groups, as 35 % of patients in the sham group also reported pain 3 to 5 days after treatment.  Other than pain during treatment, there were no significant differences in the nature or type of adverse events reported between active and sham treatment groups.

The OssaTron uses an electrohydraulic method of generating shock waves, which are focused so that they converge at a point near the surface of the foot.  Typically, 1,500 shocks are necessary for treatment, which is performed on an outpatient surgical center under local or general anesthesia.

In support of their pre-market application, the manufacturer of the OssaTron submitted to the Food and Drug Administration (FDA) the results of a clinical trial involving 300 patients with plantar fasciitis that was not adequately responsive to conservative treatments.  Patients were randomly assigned to the active extracorporeal shock wave therapy or sham treatment.  Patients were evaluated on the 4 following criteria:

1. investigator assessment of heel pain, with positive response defined as greater than 50 % improvement over baseline and a VAS score of 4 or less on a 10-point scale;
2. the patient's self-assessment of pain, with a positive response defined as greater than 50 % improvement over baseline and a VAS score of less than 4;
3. the patient's self-assessment of activity, with a positive response defined as improvement of 1 point on a 5-point scale, or maintenance of a baseline score of 0 or 1; and
4. use of pain medications, with a positive response defined as no use of pain medications for heel pain.

After 12 weeks, the only clinically significant difference between active and sham treatments was in the investigator assessment of heel pain: 46 % of the OssaTron-treated patients and 30 % of the sham-treated patients had an improvement of more than 5.0 units on a 10-unit VAS at 12 weeks, as assessed by the investigator.  However, the self-assessed pain score showed only marginal differences between the treatment and placebo groups, and the other 2 endpoints -- self-assessment of activity and use of pain medications -- were not statistically different between the 2 groups.  Side effects of Ossatron ESWT included nerve complications (nerve irritation, numbness) in 6 patients and plantar fascial tears in 2 patients.  The FDA is requiring a study to further evaluate these adverse effects.

In a randomized controlled study (n = 160), Buchbinder et al (2002) found no evidence to support a beneficial effect on pain, function, and quality of life of ultrasound-guided ESWT over placebo in patients with ultrasound-proven plantar fasciitis 6 and 12 weeks following treatment.  Commenting on the results of the study by Buchbinder and colleagues, Ham and Strayer (2002) stated that "[e]xtracorporeal shock wave therapy cannot be recommended to improve pain and function in patients with plantar fasciitis based on the results of this study.  Although previous studies do report a benefit from ESWT, this study appears to represent a higher level of evidence than was previously available for evaluating the efficacy of this therapy.  An updated meta-analysis combining all the studies on ESWT will be useful".

Aetna's policy on the unproven status of ESWT for plantar fasciitis is supported by the conclusions of more than 12 systematic evidence reviews, including those from national and international authorities (including the Cochrane Collaboration (Crawford and Thomson, 2010), BMJ Clinical Evidence (Landorf and Menz, 2007), the Washington State Department of Labor and Industries (2003), the BlueCross BlueShield Association Technology Evaluation Center (2003, 2005), the Institute for Clinical Systems Improvement (2004), the California Technology Assessment Forum (Tice, 2004; CTAF, 2007; CTAF, 2009), the National Institute for Health and Clinical Excellence (2005), BMC Musculoskeletal Disorders (Thomson et al, 2005), the Canadian Agency for Drugs and Technologies in Health (Ho, 2007), and the Galacian Agency for Health Technology Assessment (Ruano-Ravina, 2004)), and from other investigator groups (Cole et al, 2005; Buchbinder, 2004; Burton and Overend, 2005; Boddeker et al, 2004; and Atkins et al, 1999).

These systematic evidence reviews of ESWT for plantar fasciitis have concluded that the effectiveness of this intervention is unknown.  Pain associated with ESWT and differences in procedures mean that blinding in placebo- or sham-controlled trials is probably not maintained.  Rajkumar and Schmitgen (2002) concluded that additional controlled studies are required to define the precise role of this new modality in the treatment of chronic plantar fasciitis.

An assessment of ESWT for plantar fasciitis conducted by the Washington State Department of Labor and Industries (2003) concluded that "the evidence establishing the effectiveness [of ESWT] for musculoskeletal conditions remains inconclusive." 

In a double-blind randomized controlled study (n = 88), Speed et al (2003) concluded that there appears to be no treatment effect of moderate dose ESWT in subjects with plantar fasciitis.  The investigators stated that further research is needed to develop evidence based recommendation for the use ESWT in musculoskeletal complaints.  This is in agreement with findings of a study by Haake et al (2003) (n = 272) who reported that ESWT is ineffective in the treatment of chronic plantar fasciitis. 

The BlueCross BlueShield Association Technology Evaluation Center (BCBSA, 2003) re-assessed ESWT for plantar fasciitis, and reversed position on the effectiveness of this therapy.  The 2003 TEC assessment stated: "[i]n summary, the available evidence consists largely of good quality studies; there are 3 double-blind, randomized controlled trials that included over 600 patients.  Overall, the results of the trials are inconclusive.  If ESWT provided a clinically significant improvement in plantar fasciitis, one would expect consistent improvement across multiple ways of measuring pain and function (e.g., morning pain, use of pain medications, ability to walk without pain).  However, the results of various measures within studies and across studies do not give a consistent picture concerning the effect of ESWT on health outcomes for plantar fasciitis.”  The TEC assessment (BCBSA, 2003) concluded that “[t]he evidence is not sufficient to permit conclusions on the health outcome effects of ESWT” for plantar fasciitis.  The BlueCross BlueShield Association Technology Evaluation Center re-affirmed their position in a subsequent assessment published in 2005 (BCBSA, 2005).

In an evidence review of plantar fasciitis treatments published in the New England Journal of Medicine, Buchbinder (2004) concluded that “the available data do not provide substantive support for [the] use” of ESWT for plantar fasciitis. 

Although recent reports seem to provide evidence that ESWT may be effective in the treatment of plantar fasciitis, there are drawbacks in these studies.  The study by Odgen et al (2004) appears to be a follow-up report on the same patients in their previous reports, providing data on 1-year and longer.  Theodore et al (2004) concluded that ESWT represents a safe treatment option for chronic plantar fasciitis.  In the study by Theodore et al, there was a significant difference (p = 0.0435) in VAS at 3-month between the 2 groups: 3.4 +/- 2.7 for the treatment group and 4.1 +/- 3.1 for the control group.  There appears to be a wide overlap of VAS between the 2 groups.  Furthermore, it is unclear whether these small differences are clinically significant as indicated by the lack of difference in VAS during the first few mins of walking in the morning between the 2 groups.  There are also no differences in AOFAS and SF-12 health status questionnaire scores between the 2 groups.  In addition, it is of note that there were no differences in Roles and Maudsley Score at 6-week follow-up between the 2 groups.  Moreover, 38.4 % of patients in the treatment group reported a fair to poor Roles and Maudsley Score at 3-month compared to only 6.3 % of their counterparts in the control group.  More importantly, it is unclear why the study was unblinded at 3 months.  It would have been interesting to have the patients in the control group remained in the original protocol and compared their results with those from the treatment group at 12-month.

A technology assessment by the Institute for Clinical Systems Improvement (2004) concluded that "[t]he scientific evidence, to date, does not permit a conclusion to be reached regarding the efficacy of ESWT for plantar fasciitis."  This is in agreement with the assessment by the BlueCross BlueShield Association’s Technology Evaluation Center (2005), which concluded that ESWT for chronic plantar fasciitis has not been demonstrated to improve health outcomes in the investigational setting.  Thus, ESWT for chronic plantar fasciitis does not meet the TEC criteria.

An assessment of ESWT for musculoskeletal disorders prepared for the California Technology Assessment Forum (CTAF) stated that ESWT for plantar fasciitis does not meet CTAF’s assessment criteria (Tice, 2004).  The assessment explained that plantar fasciitis tends to improve over extended periods of time, even for patients who have failed conservative therapy for several months.  Therefore, uncontrolled studies of ESWT for plantar fasciitis were promising, but may represent mainly the natural history of this disorder abetted by a strong placebo effect.  The CTAF assessment explained that studies with pain as the primary outcome commonly are subject to large placebo effects (Tice, 2004).  The assessment observed that, in the non-blinded randomized controlled trials of ESWT, the placebo group usually reported minimal improvements while the placebo group in the well-blinded studies reported 30 to 50 % improvements in pain scores.  The assessment stated that this observation highlights the need for high quality, double-blinded, randomized trials as the minimum standard of evidence for ESWT in plantar fasciitis.  The CTAF assessment noted that the 9 randomized controlled clinical trials of ESWT for plantar fasciitis illustrate this point (Tice, 2004).  The assessment found “a tremendous amount” of variability in the quality of the randomized trials and in the interventions studied.  The assessment found that the fair to poor quality studies demonstrated benefit compared with sham or delayed therapy, but the trials were generally small, with inadequate blinding, poor allocation concealment, and differential loss to follow-up, which could have biased the study results in favor of ESWT.  In contrast, the assessment found that the 2 good quality studies found no evidence for benefit compared with sham ESWT.

The CTAF re-assessed the evidence for ESWT for plantar fasciitis, and found that this does not meet CTAF criteria (Tice, 2009).  The CTAF assessment explained that patients with plantar fasciitis tend to improve over extended periods of time, even patients who have failed conservative therapy for months.  Therefore, the uncontrolled studies of ESWT, while promising, may represent mainly the natural history of the disorders abetted by a strong placebo effect.  Studies with pain as the primary outcome commonly are subject to large placebo effects.  The CTAF assessment observed that, in the non-blinded randomized controlled trials of ESWT, the placebo group usually reported minimal improvements, while the placebo group in the well blinded studies reported 30 to 50 % improvements in pain scores.  The CTAF assessment concluded, therefore, that high quality, double-blinded, randomized trials are the minimum standard of evidence (Tice, 2009).

The CTAF report stated that meta-analysis of the 19 randomized controlled trials of ESWT for plantar fasciitis illustrates this quite clearly (Tice, 2009).  The CTAF assessment found significant variability in the quality of the randomized trials and in the interventions studied.  However, only the quality of the studies was significantly associated with the magnitude of the benefit observed in the clinical trials.  The CTAF report observed that fair to poor quality studies demonstrated benefit compared with sham or delayed therapy, but the trials were generally small, with inadequate blinding, poor allocation concealment, and differential loss to follow-up, which could have biased the study results in favor of ESWT.  However, 2 of the 4 good quality studies found no evidence for benefit compared with sham ESWT.  Furthermore, the CTAF report found strong evidence for publication bias in the available literature.  The asymmetry of the funnel plot indicates that many small studies with negative results have been performed, but not published.  Finally, CTAF found that many different variations of ESWT were tried in these trials -- no specific device or protocol was clearly superior to the others.  The CTAF report stated that there may be a form of ESWT that effectively speeds healing of plantar fasciitis, but it remains to be defined.  The literature does not clearly support a benefit of high energy compared with low energy ESWT nor is it clear that the use of anesthesia blocks the benefits of ESWT.  "Until unequivocal benefit is consistently demonstrated in high quality clinical trials, ESWT should remain investigational" (Tice, 2009).  

It is interesting to note that a randomized controlled study (n = 125; Porter and Shadbolt, 2005) reported that corticosteroid injection is more effective and multiple times more cost-effective than ESWT in the treatment of plantar fasciopathy that has been symptomatic for more than 6 weeks.  In addition, a recent review on the use of ESWT for the treatment of orthopedic diseases (Trebinjac et al, 2005) found that results on the effectiveness of ESWT are controversial.  Studies that have claimed therapeutic benefit did not fulfill scientific criteria and randomized controlled trials were not able to confirm significant improvement after treatment with ESWT.

An assessment by the National Institute for Health and Clinical Excellence (NICE, 2005) about ESWT for plantar fasciitis reached the following conclusion: "[c]urrent evidence on extracorporeal shockwave therapy for refractory tendinopathies (specifically tennis elbow and plantar fasciitis) suggests that there are no major safety concerns.  Evidence on efficacy is conflicting, and suggests that the procedure produces little benefit apart from a placebo response in some patients.  Therefore, current evidence on efficacy does not appear adequate to support its use without special arrangements for consent, and for audit or research."

A systematic evidence review and metaanalysis for BMC Musculoskeletal Disorders (Thomson et al, 2005) reported that the results of the review did not support the use of ESWT for plantar heel pain in clinical practice.  The authors reported that ESWT was effective for the treatment of plantar heel pain, but the effect size was small; when only high-quality trials were considered, this effect was not shown to be statistically significant.

The Canadian Agency for Drugs and Technologies in Health's report on ESWT for chronic plantar fasciitis (Ho, 2007) stated that "the lack of convergent findings from randomized trials of ESWT for chronic plantar fasciitis suggests uncertainty about its effectiveness.  The evidence reviewed in this bulletin does not support the use of this technology for this condition."

A meta-analysis of ESWT for plantar fasciitis not responding to conservative therapy (2007) conducted by the CTAF (2007) concluded that the use of ESWT for the treatment of plantar fasciitis does not meet CTAF's technology assessment criteria.  Meta-analysis of the 14 randomized controlled clinical trials of ESWT for plantar fasciitis identified significant variability in the quality of the randomized trials and in the interventions studied.  The assessment found, however, that only the quality of the studies was significantly associated with the magnitude of the benefit observed in the clinical trials.  The CTAF assessment found that fair to poor quality studies demonstrated benefit compared with sham or delayed therapy, but the trials were generally small, with inadequate blinding, poor allocation concealment, and differential loss to follow-up, which could have biased the study results in favor of ESWT.  In contrast, 2 of the 3 good quality studies found no evidence for benefit compared with sham ESWT.

Tornese and co-workers (2008) compared 2 ESWT techniques for the treatment of painful subcalcaneal spur.  A total of 45 subjects with a history of at least 6 months of heel pain were studied.  Each subject received a 3-session ultrasound-guided ESWT (performed weekly).  Perpendicular technique was used in group A (n = 22, mean age of 59.3 +/- 12 years) and tangential technique was used in group B (n = 23, mean age of 58.8 +/- 12.3 years).  Mayo Clinical Scoring System was used to evaluate each subject before the treatment and at 2 and 8 months follow-up.  Mayo Clinical Scoring System pre-treatment scores were homogeneous between the groups (group A = 55.2 +/-18.7; group B = 53.5 +/- 20; p > 0.05).  In both groups there was a significant (p < 0.05) increase in the Mayo Clinical Scoring System score at 2 months (group A = 83.9 +/- 13.7; group B = 80 +/- 15.8) and 8 months (group A = 90 +/- 10.5; group B = 90.2 +/- 8.7) follow-up.  No significant differences were obtained comparing the Mayo Clinical Scoring System scores of the 2 groups at 2 and 8 months follow-up.  The authors concluded that there was no difference between the 2 techniques of using ESWT.  The tangential technique was found to be better-tolerated regarding treatment-induced pain, allowing higher energy dosages to be used.  The drawbacks of this study were lack of a control group, small sample size, and a relavely short follow-up period.

In a randomized controlled trial, Gerdesmeyer and colleagues (2008) examined the effects of radial ESWT in the treatment of chronic recalcitrant plantar fasciitis.  Three interventions of radial ESWT (0.16 mJ/mm(2); 2,000 impulses) compared with placebo were studied in 245 patients.  Primary endpoints were changes in VAS composite score from baseline to 12 weeks' follow-up, overall success rates, and success rates of the single VAS scores (heel pain at first steps in the morning, during daily activities, during standardized pressure force).  Secondary endpoints were single changes in VAS scores, success rates, Roles and Maudsley score, SF-36, and patients' and investigators' global judgment of effectiveness 12 weeks and 12 months after ESWT.  Radial ESWT proved significantly superior to placebo with a reduction of the VAS composite score of 72.1 % compared with 44.7 % (p = 0.0220), and an overall success rate of 61.0 % compared with 42.2 % in the placebo group (P = .0020) at 12 weeks.  Superiority was even more pronounced at 12 months, and all secondary outcome measures supported radial ESWT to be significantly superior to placebo (p < 0.025, 1-sided).  No relevant side effects were observed.  The authors concluded that radial ESWT significantly improves pain, function, and quality of life compared with placebo in patients with recalcitrant plantar fasciitis.  The positive findings of this study need to be validated by further investigation.

Cryosurgery is also being studied for the treatment of plantar fasciitis.  In a prospective study (Allen et al, 2007), 59 consecutive patients (61 heels), who had failed prior conservative therapy and were considered surgical candidates were treated with cryosurgery in an office setting.  Patients were evaluated on an 11-point VAS administered pre-operatively and up to 1 year of follow-up.  The mean pain rating (8.38) before cryosurgery (day 0) is statistically significant to the mean pain rating (1.26) at day 365 post-operatively.  Pain decreased significantly after the procedure (analysis of variance, p < 0.0001).  These results suggested that cryosurgery may be effective in treating patients with recalcitrant plantar fasciitis.  However, it should be noted that this was an uncontrolled study with a small sample size.  Its findings need to be validated by well-designed studies.

Niewald and associates (2008) stated that a lot of retrospective data concerning the effect of radiotherapy on plantar fasciitis is available in the literature.  Nevertheless, a randomized proof of this effect is still missing.  Thus, the GCGBD (German cooperative group on radiotherapy for benign diseases) of the DEGRO (German Society for Radiation Oncology) decided to start a randomized multi-center trial in order to find out if the effect of a conventional total dose is superior compared to that of a very low dose.  In a prospective, controlled and randomized phase III trial, 2 radiotherapy schedules were compared:

1. standard arm -- total dose 6.0 Gy in single fractions of 1.0 Gy applied twice-weekly, and
2. experimental arm -- total dose 0.6 Gy in single fractions of 0.1 Gy applied twice-weekly (acting as a placebo). 

Patients aged over 40 years who have been diagnosed clinically and radiologically to be suffering from plantar fasciitis for at least 6 months can be included.  Former trauma, surgery or radiotherapy to the heel are not allowed nor are patients with a severe psychiatric disease or women during pregnancy and breast-feeding.  According to the statistical power calculation, 100 patients have to be enrolled into each arm.  After having obtaining a written informed consent a patient is randomized by the statistician to one of the arms mentioned above.  After radiotherapy, patients are seen first every 6 weeks, then regularly up to 48 months after therapy; they additionally receive a questionnaire every 6 weeks after the follow-up examinations.  The effect is measured using several target variables (scores): Calcaneodynia-score according to Rowe et al, SF-12 score, and VAS of pain.  The most important endpoint is the pain relief 3 months after therapy.  Patients with an inadequate result are offered a second radiotherapy series applying the standard dose (equally in both arms).  This trial protocol has been approved by the expert panel of the DEGRO as well as by the Ethics committee of the Saarland Physicians' Chamber.

Drilling and microfracture of the subchondral bone are techniques used to stimulate the intrinsic repair (fibro-cartilage) process for injured/defective articular cartilage.  However, there is a lack of evidence regarding the effectiveness of drilling or microfracture in the treatment of plantar fasciitis.

In a multi-center randomized clinical trial, Cleland and colleagues (2009) compared the effectiveness of 2 different conservative management approaches in the treatment of plantar heel pain.  Patients with a primary report of plantar heel pain underwent a standard evaluation and completed a number of patient self-report questionnaires, including the Lower Extremity Functional Scale (LEFS), the Foot and Ankle Ability Measure (FAAM), and the Numeric Pain Rating Scale (NPRS).  Patients were randomly assigned to be treated with either an electrophysical agents and exercise (EPAX) or a manual physical therapy and exercise (MTEX) approach.  Outcomes of interest were captured at baseline and at 4-week and 6-month follow-ups.  The primary aim (effects of treatment on pain and disability) was examined with a mixed-model analysis of variance (ANOVA).  The hypothesis of interest was the 2-way interaction (group by time).  A total of 60 subjects (mean [SD] age, 48.4 [8.7] years) satisfied the eligibility criteria, agreed to participate, and were randomized into the EPAX (n = 30) or MTEX group (n = 30).  The overall group-by-time interaction for the ANOVA was statistically significant for the LEFS (p = 0.002), FAAM (p = 0.005), and pain (p = 0.043).  Between-group differences favored the MTEX group at both 4-week (difference in LEFS, 13.5; 95 % confidence interval [CI]: 6.3 to 20.8) and 6-month (9.9; 95 % CI: 1.2 to 18.6) follow-ups.  The authors concluded that the results of this study provided evidence that MTEX is a superior management approach over an EPAX approach in the management of individuals with plantar heel pain at both the short- and long-term follow-ups.

Rompe et al (2010) tested the null hypothesis of no difference in the effectiveness of plantar fascia-specific stretching and shock-wave therapy for patients who had unilateral plantar fasciopathy for a maximum duration of 6 weeks and which had not been treated previously.  A total of 102 patients with acute plantar fasciopathy were randomly assigned to perform an 8-week plantar fascia-specific stretching program (group I, n = 54) or to receive repetitive low-energy radial shock-wave therapy without local anesthesia, administered weekly for 3 weeks (group II, n = 48).  All patients completed the 7-item pain subscale of the validated Foot Function Index and a patient-relevant outcome questionnaire.  Patients were evaluated at baseline and at 2, 4, and 15 months after baseline.  The primary outcome measures were a mean change in the Foot Function Index sum score at 2 months after baseline, a mean change in item 2 (pain during the first few steps of walking in the morning) on this index, and satisfaction with treatment.  No difference in mean age, sex, weight, or duration of symptoms was found between the groups at baseline.  At 2 months after baseline, the Foot Function Index sum score showed significantly greater changes for the patients managed with plantar fascia-specific stretching than for those managed with shock-wave therapy (p < 0.001), as well as individually for item 2 (p = 0.002).  Thirty-five patients (65 %) in group I versus 14 patients (29 %) in group II were satisfied with the treatment (p < 0.001).  These findings persisted at 4 months.  At 15 months after baseline, no significant between-group difference was measured.  The authors concluded that a program of manual stretching exercises specific to the plantar fascia is superior to repetitive low-energy radial shock-wave therapy for the treatment of acute symptoms of proximal plantar fasciopathy.

In a pilot study, Dogramaci et al (2010) examined the clinical efficacy of intracorporeal pneumatic shock therapy (IPST) application for the treatment of chronic plantar fasciitis using a pneumatic lithotripter.  A total of 50 patients with clinically and radiologically confirmed plantar fasciitis were randomly allocated to either an active (treatment) (n = 25) or inactive (placebo) (n = 25) group.  Under local anesthesia and posterior tibial nerve block, a rigid probe was directly introduced into the calcaneal spur under fluoroscopic control; a standard protocol of 1,000 shocks was applied during a single session into the calcaneal spur.  The main outcome measure was patients' subjective assessment of pain by means of a VAS and the Roles and Maudsley Score before the treatment and 6 months later.  At the 6 months, the rate of successful outcomes (excellent + good results) in the treatment group (92 %) were significantly higher comparing to the control group (24 %) (p < 0.001).  Heel pain measured 6 months after using the VAS were 2.04 +/- 1.67 in the treatment group and 7.16 +/- 1.57 in the control group as compared to 8.92 +/- 1.22 and 9.12 +/- 1.23, respectively before the commencement of the treatment.  No complications attributable to the procedure such as rupture of the planter fascia, hematoma, or infection were observed during the study.  The authors concluded that these findings showed that IPST is a safe and effective method in the treatment of patients with chronic plantar fasciitis not responding to conservative measures.  It should be considered before surgical intervention when ESWT is not available for daily practice.  Moreover, they stated that further evaluation of this novel treatment is necessary to understand the exact mechanism of action.

Peerbooms et al (2010) described the design of a multi-center randomized controlled trial to study the use of platelet rich plasma in the treatment of plantar fasciitis.  The study population consists of 120 patients aged 18 years and older.  Patients with chronic plantar fasciitis will be allocated randomly to have a steroid injection or an autologous platelet concentrate injections.  Data will be collected before the procedure, 4, 8, 12, 26 weeks and 1 year after the procedure.  The main outcome measures of this study are pain and function measured with questionnaires.

Cotchett et al (2011) described the design of a randomized controlled trial to evaluate the effectiveness of dry needling for plantar heel pain.  A total of 80 community-dwelling men and woman aged over 18 years with plantar heel pain (who satisfy the inclusion and exclusion criteria) will be recruited.  Eligible participants with plantar heel pain will be randomized to receive either 1 of 2 interventions,

1. real dry needling, or
2. sham dry needling. 

The protocol (including needling details and treatment regimen) was formulated by general consensus (using the Delphi research method) using 30 experts worldwide that commonly use dry needling for plantar heel pain.  Primary outcome measures will be the pain subscale of the Foot Health Status Questionnaire and "first step" pain as measured on a VAS.  The secondary outcome measures will be health-related quality of life (assessed using the Short Form-36 questionnaire - Version Two) and depression, anxiety and stress (assessed using the Depression, Anxiety and Stress Scale - short version).  Primary outcome measures will be performed at baseline, 2, 4, 6 and 12 weeks and secondary outcome measures will be performed at baseline, 6 and 12 weeks.  Data will be analyzed using the intention-to-treat principle.  The authors concluded that this study is the first randomized controlled trial to evaluate the effectiveness of dry needling for plantar heel pain.  The trial will be reported in accordance with the Consolidated Standards of Reporting Trials and the Standards for Reporting Interventions in Clinical Trials of Acupuncture guidelines.  The findings from this trial will provide evidence for the effectiveness of trigger point dry needling for plantar heel pain.

Zhang et al (2011) examine the efficacy of botulinum toxin type A (BoNTA) in reducing chronic musculoskeletal pain.  Studies for inclusion in this report were identified using MEDLINE, EMBASE, PUBMED, Cochrane Central Register of Controlled Trials, CINAHL, and reference lists of relevant articles.  Studies were considered eligible for inclusion if they were randomized controlled trials (RCTs), evaluating the efficacy of BoNTA injections in pain reduction.  All studies were assessed and data were abstracted independently by paired reviewers.  The outcome measures were baseline and final pain scores as assessed by the patients.  The internal validity of trials was assessed with the Jadad scale.  Disagreements were resolved through discussions.  A total of 21 studies were included in the systematic review and 15 of them were included in the final meta-analysis.  There was a total of 706 patients in the meta-analysis, represented from trials of plantar fasciitis (n = 1), tennis elbow (n = 2), shoulder pain (n = 1), whiplash (n = 3), and myofascial pain (n = 8).  Overall, there was a small to moderate pain reduction among BoNTA patients when compared to control (standardized mean difference [SMD] = -0.27, 95 % CI: -0.44 to -0.11).  When the results were analyzed in subgroups, only tennis elbow (SMD = -0.44, 95 % CI: -0.86 to -0.01) and plantar fasciitis (SMD = -1.04, 95 % CI: -1.68 to -0.40) demonstrated significant pain relief.  Although not in the meta-analysis, 1 back pain study also demonstrated positive results for BoNTA.  Lastly, BoNTA was effective when used at greater than or equal to 25 units per anatomical site or after a period greater than or equal to 5 weeks.  In this meta-analysis, BoNTA had a small to moderate analgesic effect in chronic musculoskeletal pain conditions.  It was particularly effective in plantar fasciitis, tennis elbow, and back pain, but not in whiplash or shoulder pain patients.  However, more evidence is required before definitive conclusions can be drawn.  On the other hand, there is convincing evidence that BoNTA lacks strong analgesic effects in patients with myofascial pain syndrome.

Diaz-Llopis et al (2012) examined the effectiveness of BoNTA in chronic plantar fasciitis compared to the local injection of a corticosteroid plus local anesthetic.  Patients with a clinical diagnosis of plantar fasciitis made at least 6 months earlier were selected to enter a randomized, single-blind study of treatment with injections of botulinum toxin type A or corticosteroid.  There were 28 patients in each treatment group.  Patients were evaluated at 1 month using the Foot Health Square Questionnaire and those with no clinical response subsequently received a 2nd injection with the drug of the other arm of the study, creating 2 new treatment groups.  Re-evaluation was performed at 6 months.  One month after injection there was a clear clinical improvement in both treatment groups but it was greater in the botulinum toxin group, with a significant difference for the pain item (p = 0.069), though not in other items.  At 6 months, patients treated with botulinum toxin type A had continued to improve in all items, whereas the corticosteroid group lost part of the improvement achieved at 1 month (improvement with botulinum toxin versus corticosteroid: pain 19.10/-6.84 (p = 0.001), function 16.00/-8.80 (p < 0.001), footwear 13.48/-7.95 (p = 0.004), self-perceived foot health 25.44/-5.41 (p < 0.001).  The authors concluded that BoNTA should be considered for the treatment of chronic plantar fasciitis in view of the improvement found at 1 month, and particularly at 6 months, when this treatment clearly has better results than corticosteroid injections.  They stated that further studies with larger samples are necessary to confirm these results.

In a double-blind, multi-center, randomized, placebo-controlled study, Brook et al (2012) evaluated the clinical value of pulsed radiofrequency electromagnetic field (PREF) therapy as a potential novel treatment of plantar fasciitis.  A small, wearable, extended-use PRFE device was employed in this study.  A total of 70 subjects diagnosed with plantar fasciitis were enrolled in the present study.  The subjects were randomly assigned a placebo or active PRFE device.  Subjects were instructed to wear the PRFE device over-night, record their morning and evening pain using a 0- to 10-point VAS, and log any medication use.  The primary outcome measure for the present study was morning pain, a hallmark of plantar fasciitis.  The study group using the active PRFE device showed progressive decline in morning pain.  The day 7 AM-VAS score was 40 % lower than the day 1 AM-VAS score.  The control group, in comparison, showed a 7 % decline.  A significantly different decline was demonstrated between the 2 groups (p = 0.03).  The PM-VAS scores declined by 30 % in the study group compared to 19 % in the control group, although the difference was non-significant.  Medication use in the study group also showed a trend downward, but the use in the control group remained consistent with the day 1 levels.  The authors concluded that PRFE therapy worn on a nightly basis appears to offer a simple, drug-free, non-invasive therapy to reduce the pain associated with plantar fasciitis.  The findings of this study need to be validated by further investigations especially since there were no significant differences in VAS score between the study and control groups.

The National Institute for Health and Clinical Excellence assessment on “Autologous blood injection for plantar fasciitis” (NICE, 2013) concluded that “The evidence on autologous blood injection for plantar fasciitis raises no major safety concerns.  The evidence on efficacy is inadequate in quantity and quality.  Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research . . . .  NICE encourages further research comparing autologous blood injection (with or without techniques to produce platelet-rich plasma) against established treatments for managing plantar fasciitis.  Trials should clearly describe patient selection, including duration of symptoms and any prior treatments.  Outcomes should include specific measures of pain and function”.

Morris et al (2013) examined the effect of Kinesio Tex tape (KTT) from RCTs in the management of clinical conditions.  A systematic literature search of CINAHL; MEDLINE; OVID; AMED; SCIENCE DIRECT; PEDRO; SPORT DISCUS; BRITISH NURSING INDEX; COCHRANE CENTRAL REGISTER OF CLINICAL TRIALS; and PROQUEST was performed up to April 2012.  The risk of bias and quality of evidence grading was performed using the Cochrane collaboration methodology.  A total of 8 RCTs met the full inclusion/exclusion criteria; 6 of these included patients with musculoskeletal conditions; 1 included patients with breast-cancer-related lymphedema; and 1 included stroke patients with muscle spasticity.  Six studies included a sham or usual care tape/bandage group.  There was limited to moderate evidence that KTT is no more clinically effective than sham or usual care tape/bandage.  There was limited evidence from 1 moderate quality RCT that KTT in conjunction with physiotherapy was clinically beneficial for plantar fasciitis related pain in the short-term; however, there were serious questions around the internal validity of this RCT.  The authors concluded that there currently exists insufficient evidence to support the use of KTT over other modalities in clinical practice.

Zelen et al (2013) reported the results of a feasibility study examining the effectiveness of micronized dehydrated human amniotic/chorionic membrane (mDHACM) injection as a treatment for chronic refractory plantar fasciitis.  An institutional review board-approved, prospective, randomized, single-center clinical trial was performed.  A total of 45 patients were randomized to receive injection of 2 cc 0.5 % Marcaine plain, then either 1.25 cc saline (controls), 0.5 cc mDHACM, or 1.25 cc mDHACM.  Follow-up visits occurred over 8 weeks to measure function, pain, and functional health and well-being.  Significant improvement in plantar fasciitis symptoms was observed in patients receiving 0.5 cc or 1.25 cc mDHACM versus controls within 1 week of treatment and throughout the study period.  At 1 week, AOFAS Hindfoot scores increased by a mean of 2.2 ± 17.4 points for controls versus 38.7 ± 11.4 points for those receiving 0.5 cc mDHACM (p < 0.001) and 33.7 ± 14.0 points for those receiving 1.25 cc mDHACM (p < 0.001).  By week 8 AOFAS Hindfoot scores increased by a mean of 12.9 ± 16.9 points for controls versus 51.6 ± 10.1 and 53.3 ± 9.4 for those receiving 0.5 cc and 1.25 cc mDHACM, respectively (both p < 0.001).  No significant difference in treatment response was observed in patients receiving 0.5 cc versus 1.25 cc mDHACM.  The authors concluded that in patients with refractory plantar fasciitis, mDHACM is a viable treatment option.  Moreover they stated that larger studies are needed to confirm these findings.

In a meta-analysis, Yin et al (2014) examined the effectiveness of ESWT and provided clinicians with an evidence base for their clinical decision-making.  PubMed, MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Evidence-Based Medicine Reviews served as data sources.  All randomized or quasi-randomized controlled trials of ESWT for chronic recalcitrant plantar fasciitis were searched.  Searching identified 108 potentially relevant articles; of these, 7 studies with 550 participants met inclusion criteria.  Number of patients, population, body mass index (BMI), duration of symptoms, adverse effects, blinding method, and details of shockwave therapy were extracted.  For intervention success rate, ESWT of low intensity was more effective than control treatment of low intensity.  For pain relief, the pooled data showed a significant difference between the ESWT and control groups.  For function, only low-intensity ESWT was significantly superior over the control treatment.  The authors concluded that the effectiveness of low-intensity ESWT is worthy of recognition.  The short-term pain relief and functional outcomes of this treatment are satisfactory.  However, they noted that owing to the lack of a long-term follow-up, its long-term effectiveness remains unknown.

In a systematic review, Sandrey (2014) evaluated the literature to critically consider the effects of growth factors delivered through autologous whole-blood and platelet-rich-plasma (PRP) injections in managing wrist-flexor and -extensor tendinopathies, plantar fasciopathy, and patellar tendinopathy.  The primary question was, according to the published literature, is there sufficient evidence to support the use of growth factors delivered through autologous whole-blood and PRP injections for chronic tendinopathy?  The authors performed a comprehensive, systematic literature search in October 2009 using PubMed, MEDLINE, EMBASE, CINAHL, and the Cochrane library without time limits.  The following key words were used in different combinations: tendinopathy, tendinosis, tendinitis, tendons, tennis elbow, plantar fasciitis, platelet rich plasma, platelet transfusion, and autologous blood or injection.  The search was limited to human studies in English.  All bibliographies from the initial literature search were also viewed to identify additional relevant studies.  Studies were eligible based on the following criteria:

1. Articles were suitable (inclusion criteria) if the participants had been clinically diagnosed as having chronic tendinopathy;
2. the design had to be a prospective clinical study, RCT, non-RCT, or prospective case series;
3. a well-described intervention in the form of a growth factor injection with either PRP or autologous whole blood was used; and
4. the outcome was reported in terms of pain or function (or both). 

All titles and abstracts were assessed by 2 researchers, and all relevant articles were obtained.  Two researchers independently read the full text of each article to determine if it met the inclusion criteria.  If opinions differed on suitability, a third reviewer was consulted to reach consensus.  The data extracted included number of participants, study design, inclusion criteria, intervention, control group, primary outcome measures (pain using a visual analog or ordinal scale or function), time of follow-up, and outcomes for intervention and control group (percentage improvement) using a standardized data-extraction form.  Function was evaluated in 9 of the 11 studies using

1. the Nirschl scale (elbow function) or the modified Mayo score for wrist flexors and extensors,
2. the Victorian Institute of Sports Assessment-Patella score, a validated outcome measure for patellar tendinopathy, or the Tegner score for patellar tendinopathy, and
3. the rear-foot score from the American Orthopaedic Foot and Ankle Scale for plantar fasciopathy. 

The Physiotherapy Evidence Database (PEDro) scale contains 11 items; items 2 to 11 receive 1 point each for a yes response.  Reliability is sufficient (0.68) for the PEDro scale to be used to assess physiotherapy trials.  A score of 6 or higher on the PEDro scale is considered a high-quality study; below 6 is considered a low-quality study.  The PEDro score results determined the quality of the RCT, non-RCT, or prospective case series (greater than or equal to 6 or less than 6).  A qualitative analysis was used with 5 levels of evidence (strong, moderate, limited, conflicting, or no evidence) to determine recommendations for the use of the intervention.  The number of high-quality or low-quality RCT or non-randomized clinical trial studies with consistent or inconsistent results determined the level of evidence (1 to 5).  Using the specific search criteria, the authors identified 418 potential sources.  After screening of the title or abstract (or both), they excluded 405 sources, which left 13 studies.  After viewing the full text, they excluded 2 additional sources (a case report and a study in which the outcome measure was remission of symptoms and not pain or function), leaving 11 studies for analysis.  Six of the 11 studies were characterized by an observational, non-controlled design; the remaining 5 studies were controlled clinical trials, 2 of which had proper randomization.  The mean number of participants included in the studies was 40.5 (range of 20 to 100).  Three of the studies were on "tennis elbow", 1 on "golfer's elbow", 1 on wrist extensor or flexor tendinopathy, 3 on plantar fasciopathy, and 3 on chronic patellar tendinopathy.  Based on the information reported, there was no standardization of frequency or method of growth factor injection treatment or of preparation of the volume, and an optimal mixture was not described.  Autologous whole-blood injections were used in 8 studies; in 5 studies, the autologous whole-blood injection was combined with a local anesthetic.  In contrast, a local anesthetic was used in only 1 of the 3 PRP injection studies.  The authors of the other 2 studies did not report whether a local anesthetic was used.  The number of autologous whole-blood and PRP injections varied, ranging from 1 to 3.  The centrifuging process was single or double for the PRP injections.  In 2 studies, calcium was added to activate the platelets.  A visual analog or ordinal pain scale was used in 10 of the 11 studies.  Function was evaluated in 9 of the 11 studies using

1. the Nirschl scale in 4 elbow studies or the modified Mayo score at baseline in 1 elbow study,
2. the Victorian Institute of Sports Assessment-Patella score for 1 study and the Tegner score for 2 of the patellar tendinopathy studies, and
3. the rear-foot score of the American Orthopaedic Foot and Ankle Scale for 1 plantar fasciopathy study.  

Only 1 study used an appropriate, disease-specific, validated tendinopathy measure (Victorian Institute of Sports Assessment-Patella).  All intervention groups reported a significant improvement in pain or function score (or both), with a mean improvement of 66 % over a mean follow-up of 9.4 months.  The control groups in these studies also showed a mean improvement of 57 %.  None of the pain benefits among the intervention groups were greater than those for the control group at final follow-up.  In 4 of the studies, the control group and the autologous growth factor injection group had similar results in pain or function or both, whereas in 2 studies, the control group had greater relief in pain than the injection group.  Eleven studies were assessed using the PEDro scale. The PEDro scores for these studies ranged from 1 to 7, with an average score of 3.4. Only 3 studies had PEDro scores of ≥6 and were considered high quality. The 3 high-quality plantar fasciopathy studies used autologous growth factor injections but did not show a significant improvement over the control group.  One of the studies that showed no beneficial effect for the autologous growth factor injections was compared with corticosteroids.  Compared with other treatments, level 1 (strong) evidence demonstrated that autologous growth factor injections did not improve pain or function in plantar fasciopathy.  The PRP injection results were based on 3 low-quality studies, 2 for the patellar tendon and 1 for the wrist flexors-extensors; level 3 (limited) evidence suggested that PRP injections improve pain or function.  The authors concluded that strong evidence indicated that autologous growth factor injections do not improve plantar fasciopathy pain or function when combined with anesthetic agents or when compared with corticosteroid injections, dry needling, or exercise therapy treatments.  Furthermore, limited evidence suggested that PRP injections are beneficial.  Except for 2 high-quality RCT studies, the rest were methodologically flawed.  They stated that additional studies should be conducted using proper control groups, randomization, blinding, and validated disability outcome measures for pain and function.  Until then, the results remain speculative because autologous whole-blood and PRP injection treatments are not standardized.

ActiveMatrix

ActiveMatrix is a pre-mixed, ambient temperature human placental connective tissue matrix intended to replace or supplement damaged or inadequate integumental tissue.  An UpToDate review on “Plantar fasciitis” (Buchbinder, 2016) does not mention ActiveMatrix, placenta, or allograft.

Cryo-Preserved Human Amniotic Membrane Injection

In a randomized, controlled, double-blind, pilot study, Hanselman and colleagues (2015) compared a novel treatment, cryo-preserved human amniotic membrane (c-hAM), to a traditional treatment, corticosteroid.  The hypothesis was that c-hAM would be safe and comparable to corticosteroids for plantar fasciitis in regard to patient outcomes.  Patients were randomized into 1 of 2 treatment groups:

1. c-hAM or
2. corticosteroid. 

Patients received an injection at their initial baseline visit with an option for a second injection at their first 6-week follow-up.  Total follow-up was obtained for 12 weeks after the most recent injection.  The primary outcome measurement was the Foot Health Status Questionnaire (FHSQ).  The secondary outcome measurements were the VAS and verbally reported percentage improvement.  Data were analyzed between groups for the 2 different cohorts (1 injection versus 2 injections).  A total of 23 patients had complete follow-up; 14 were randomized to receive corticosteroid and 9 were randomized to receive c-hAM.  Three patients in each group received second injections.  With the numbers available, the majority of outcome measurements showed no statistical difference between groups.  The corticosteroid did, however, have greater FHSQ shoe fit improvement (p = 0.0244) at 6 weeks, FHSQ general health improvement (p = 0.0132) at 6 weeks, and verbally reported improvement (p = 0.041) at 12 weeks in the 1-injection cohort.  Cryo-preserved hAM had greater FHSQ foot pain improvement (p = 0.0113) at 18 weeks in the 2-injection cohort.  The authors concluded that cryo-preserved hAM injection may be safe and comparable to corticosteroid injection for treatment of plantar fasciitis.  They stated that this was a pilot study and requires further investigation.

Light-Emitting Diode

Higgins et al (2015) compared the application of the light emitting diode (LED) to sham LED in the treatment of plantar fasciitis.  A total of 18 subjects met the inclusion criteria and were randomly assigned into 2 groups:

1. LED or
2. sham LED. 

The subjects received either the LED at 12 J/cm(2) or sham LED along 2 points of the plantar fascia.  Subjects in both groups received a 10 minute transverse friction massage and participated in 4 plantar fascia stretching exercises.  All subjects received a total of 6 treatments over 3 weeks.  Progress was assessed using the lower extremity functional and analog pain scale.  No significant difference was found between treatment groups (p = 0.845).  There was a significant difference in pain and outcome scores over time within both groups (p < 0.35).  The authors concluded that among patients with plantar fasciitis, the use of LED did not result in greater improvement in function or pain compared with sham treatment.  They stated that these findings suggested that manual intervention and passive stretching activities may have provided significant pain relief and improvement in functional outcome scores.

Plantar Fascia Partial Release Guided by Ultrasonic Energy

Patel (2015) noted that chronic plantar fasciitis is a major health care problem worldwide and affects nearly 10 % of the US population.  Although most cases resolve with conservative care, the numerous treatments for refractory plantar fasciitis attest to the lack of consensus regarding these cases.  The emerging goals for this condition are a minimally invasive percutaneous intervention that is safe, effective, and well-tolerated and has minimal morbidity and a low complication rate.  These researchers conducted a prospective study in which patients were allowed either to continue with non-invasive treatment or to undergo focal aspiration and partial fasciotomy with an ultrasonic probe.  They stated that this was the first report of a plantar fascia partial release guided by ultrasonic energy delivered by a percutaneously inserted probe under local anesthesia.  The author concluded that this procedure appeared to be a safe, effective, well-tolerated treatment for a condition that is refractory to other options.  These preliminary findings need to be validated by well-designed studies.

Transcranial Direct Current Stimulation

In an open-label, single-arm, pilot study, Concerto et al (2016) examined if primary motor cortex anodal transcranial direct current stimulation (tDCS) reduces chronic foot pain intensity and improves depression and pain-related anxiety symptoms in patients with chronic plantar fasciitis.  A total of 10 patients with symptomatic treatment-resistant plantar fasciitis were enrolled in the study.  The treatment consisted of anodal tDCS over the motor area of the leg contralateral to the symptomatic foot for 20 minutes, at 2 mA for 5 consecutive days.  Pre-tDCS (T0), post-tDCS (T1), 1 week (T2), and 4 weeks (T3) post-treatment assessments were conducted consisting of the VAS for pain intensity, the FFI, the Pain Anxiety Symptom Scale (PASS-20), and the Hamilton Rating Scale for Depression (HDRS-17 items).  Anodal tDCS treatment induced a significant improvement in pain intensity; FFI and PASS scores that were maintained up to 4 weeks post-treatment.  In addition, patients reported taking fewer pain medication tablets following the treatments.  The authors concluded that these findings indicated that anodal tDCS may be a viable treatment to control pain and psychological comorbidity in elderly patients with treatment-resistant foot pain.  These preliminary findings need to be validated by well-designed studies.

Ultrasound Therapy

An UpToDate review on “Plantar fasciitis” (Buchbinder, 2016) states that “Exercises may be beneficial, although evidence is limited.  Home exercises include plantar and calf-plantar fascia stretches, foot-ankle circles, toe curls, toe towel curls and unilateral heel raises with toe dorsiflexion.  Ultrasound therapy, ice massage, and deep friction massage may be used prior to exercise, although their effectiveness is unknown”.

In a prospective, randomized, double-blind, placebo-controlled clinical trial,, Katzap and colleagues (2018) examined the additive effect of therapeutic US in the treatment of plantar fasciitis in terms of pain, function, and quality of life (QOL).  A total of 54 patients with plantar fasciitis, aged 24 to 80 years, who met the inclusion criteria were randomized into an active intervention and a control group.  Individuals in the active intervention group were treated with self-performed stretching of the plantar fascia and calf muscles and with therapeutic US.  Individuals in the control group were treated with the same stretching exercises and sham US.  Both groups received 8 treatments, twice-weekly.  Outcome measures included a numeric pain-rating scale, the computerized adaptive test for the foot and ankle, and an algometric test.  Both groups showed statistically significant improvement in all outcome measures (p < 0.001, both groups).  At the completion of the study, no statistically significant differences were found between the groups in any of the outcomes.  The authors concluded that the addition of therapeutic US did not improve the efficacy of conservative treatment for plantar fasciitis.  Thus, these investigators recommended excluding therapeutic US from the treatment of plantar fasciitis and agreed with results of previous studies that stretching may be an effective treatment for healing plantar fasciitis.  Level of Evidence = 1b

Platelet-Rich Plasma / Platelet-Poor Plasma

Chiew and associates (2016) reviewed to the effectiveness and relevant factors of PRP treatment in managing plantar fasciitis (PF). These investigators performed a search in electronic databases, including PubMed, Scopus, and Google Scholar using different keywords.  Publications in English-language from 2010 to 2015 were included; 2 reviewers extracted data from selected articles after the quality assessment was done.  A total of 1,126 articles were retrieved, but only 12 articles met inclusion and exclusion criteria.  With a total of 455 patients, a number of potentially influencing factors on the effectiveness of PRP for PF was identified.  In all these studies, PRP had been injected directly into the plantar fascia, with or without ultrasound (US) guidance.  Steps from preparation to injection were found equally crucial.  Amount of collected blood, types of blood anti-coagulant, methods in preparing PRP, speed, and numbers of time the blood samples were centrifuged, activating agent added to the PRP and techniques of injection, were varied between different studies.  Regardless of these variations, superiority of PRP treatment compared to steroid was reported in all studies.  The authors concluded that PRP therapy might provide an effective alternative to conservative management of PF with no obvious side effect or complication; and the onset of action after PRP injection also greatly depended on the degree of degeneration.  Major drawback of these studies were:

1. small sample sizes,
2. absence of placebo, diagnosis of PF, and duration of follow-up. 

In addition, when selecting a preparation system, many factors must be taken into account, such as volume of autologous blood drawn, centrifuge rate/time, leukocyte concentration, delivery method, activating agent, final PRP volume and final platelet and growth-factor concentration.  The authors noted that due to differences in PRP characteristics, reported evidence for the clinical effectiveness of PRP cannot be generalized to all of these systems.  Furthermore, variation of hematologic parameters between patients may also affect the final PRP preparation.  Controversies regarding the optimal quantity of platelets and growth factors required for muscle and tendon healing still persist.

Vahdatpour and colleagues (2016) compared PRP and whole blood (WB) for the treatment of chronic PF. Patients with chronic PF received either an intralesional injection of 3 cc PRP prepared by double centrifuge technique or WB (n = 17 in each group).  Overall, morning and walking pain severity were assessed by 11-point numerical rating scale, and function was assessed by the Roles and Maudsley score (RMS) at baseline and 1-month and 3 months after treatment.  Ultrasonography was performed to measure plantar fascia thickness at baseline and 3 months after treatment.  Pain scores were reduced over the study in the PRP (mean change of -5.00 ± 1.17 to -5.47 ± 1.46) and WB groups (mean change of -5.29 ± 2.56 to -6.47 ± 2.83), with no difference between groups (p > 0.05).  One month and 3 months after treatment, successful treatment (RMS of less than or equal to 2) was respectively observed in 29.4 % and 82.3 % of the PRP and in 47.1 % and 76.4 % of the WB groups (p > 0.05).  Also, fascia thickness was decreased in both the PRP and WB groups (mean change of -1.74 ± 1.11 versus -1.21 ± 0.73 mm, respectively, p = 0.115).  The authors concluded that significant improvement in pain and function, as well as decrease in plantar fascia thickness, was observed by intralesional injection of the PRP and WB in patients with chronic PF.  They noted that the study results indicated similar effectiveness between PRP and WB for the treatment of chronic PF in short-term.  This study had several major drawbacks:

1. the sample size was small (n= 17 in each group), which affected the randomization quality as well,
2. the follow-up was only for 3 months,
3. due to the nature of the interventions, blinding of patients and treatment providers were not easily possible though the outcome assessors were not aware of the assigned treatments in the study,
4. the study had no placebo control group and the observed therapeutic effects in the study cannot be completely attributed to the ABDPs injection, and
5. the decrease in plantar fascia thickness after active interventions has not been observed by placebo in previous studies. 

Moreover, the authors stated that these findings need to be confirmed by further studies with a larger sample of patients and longer follow-up duration.

Yang and colleagues (2017) evaluated the current evidence concerning the efficacy and safety of PRP as a treatment for PF compared with the safety and efficacy of steroid treatments.  Databases (PubMed, Embase, and The Cochrane Library) were searched from their establishment to January 30, 2017, for RCTs comparing PRP with steroid injections as treatments for PF.  The Cochrane risk of bias (ROB) tool was used to assess the methodological quality.  Outcome measurements were the VAS, Foot and Ankle Disability Index (FADI), AOFAS scale, and the RMS.  The statistical analysis was performed with RevMan 5.3.5 software.  A total of 9 RCTs (n = 430) were included in this meta-analysis.  Significant differences in the VAS were not observed between the 2 groups after 4 [weighted mean difference (WMD) = 0.56, 95 % CI: -1.10 to 2.23, p = 0.51, I = 89 %] or 12 weeks of treatment (WMD = -0.49, 95 % CI: -1.42 to 0.44, p = 0.30, I = 89 %).  However, PRP exhibited better efficacy than the steroid treatment after 24 weeks (WMD = -0.95, 95 % CI: -1.80 to -0.11, p = 0.03, I = 85 %).  Moreover, no significant differences in the FADI, AOFAS, and RMS were observed between the 2 therapies (p > 0.05).  The authors concluded that limited evidence supported the conclusion that PRP is superior to steroid treatments for long-term pain relief; however, significant differences were not observed between short and intermediate effects.  They stated that because of the small sample size and the limited number of high-quality RCTs, additional high-quality RCTs with larger sample sizes are needed to validate these findings.

Malahias and colleagues (2018) stated that there are conflicting reports regarding the therapeutic effect of PRP versus autologous whole-blood (platelet poor plasma, PPP) injections for plantar fasciitis.  in a double-blinded, randomized, prospective study, these researchers compared the effectiveness of a single ultrasound (US)-guided PRP versus PPP injection in patients with chronic plantar fasciitis.  A total of 36 patients were recruited with clinical and sonographic evidence of chronic (greater than 6 months) plantar fasciitis, refractory to analgesics and physical therapy.  Subjects were randomly allocated into 2 groups with a sealed envelope method.  Group A included 18 patients who underwent a single US-guided PRP injection and group B included another 18 patients who underwent PPP injection with the same technique.  Follow-up was set at 3 and 6 months; no patient was lost to follow-up.  Pain, function and satisfaction were assessed using VAS, and occurrence of complications.  All scores statistically significantly improved for both groups from baseline at the 3- and 6-month follow-up evaluation, without, however, any statistically significant differences between the 2 groups with respect to pain, function and satisfaction scores.  Complications were not observed.  The authors concluded that a single US-guided PRP injection yielded similar results with PPP injection in patients with chronic plantar fasciitis.  Both treatments provided significant improvement at 6-month follow-up after the injection.  These investigators stated that these findings questioned the superiority of the PRP injection for these patients.  They stated that further studies with longer term follow-up would be welcomed.  Also, this was relative small study (n = 18 for the PRP; and n = 18 for the PPP).

Furthermore, an UpToDate review on “Plantar fasciitis” (Buchbinder, 2018) lists autologous whole blood or PRP injections, botulinum toxin injection, cryosurgery, ESWT, low-level laser therapy, and radiotherapy as unproven treatments.

In a prospective, double-blind study, Soraganvi and colleagues (2019) compared the effects of local injection of PRP and corticosteroid in the treatment of chronic PF.  Patients with the clinical diagnosis of chronic PF (heel pain of more than 6 weeks) following failed conservative treatment and plantar fascia thickness more than 4-mm were included in the study. Patients with previous surgery for PF, active bilateral plantar fasciitis, vascular insufficiency or neuropathy related to heel pain, hypothyroidism and diabetes mellitus were excluded from the study.  A total of 60 patients who fulfilled the criteria were randomly assigned to 2 groups.  Patients in Group A received PRP injection and those in Group B received steroid injection.  Patients were assessed with VAS and AOFAS score.  Assessment was carried out before injection, at 6 weeks, 3months and 6 months follow-up after injection.  Plantar fascia thickness was assessed before the intervention and 6 months after treatment using sonography.  Mean VAS in Group A decreased from 7.14 before injection to 1.41 after injection and in Group B decreased from 7.21 before injection to 1.93 after injection, at final follow-up.  Mean AOFAS score in Group A improved from 54 to 90.03 and in Group B from 55.63 to 74.67 at 6 months' follow-up.  The improvements observed in VAS and AOFAS were statistically significant.  At the end of 6 months' follow-up, plantar fascia thickness had reduced in both groups (5.78 mm to 3.35 mm in Group A and 5.6 mm to 3.75 mm in Group B) and the difference was statistically significant. The authors concluded that local injection of PRP was an effective therapeutic option for chronic PF when compared with steroid injection with long-lasting beneficial effect.

The authors stated that the main drawback of this study was the variability of platelet concentration among different patients; lack of standardization in preparation, concentration of platelets and dosage were barriers for critical evaluation. They stated that further basic research is needed in this field for understanding the exact mechanism of action of PRP; the results of PRP injection as a biological modality of treatment in orthopedic conditions are encouraging.

Hohmann and colleagues (2020) carried out a systematic review and meta-analysis comparing intralesional injections of PRP and steroid infiltration.  These investigators performed a systematic review of Medline, Embase, Scopus, and Google Scholar including all level 1 and 2 studies from 2010 to 2019; AOFAS and VAS for pain scores were used as outcome variables.  Publication bias and risk of bias was evaluated with the Cochrane Collaboration tools.  The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system was used to examine the quality of the body of evidence.  Heterogeneity was assessed with χ2 and I2 statistics.  A total of 15 studies were included in the analysis; 9 had a high risk of bias.  There was 1 study with high quality, 9 with moderate, 2 studies with low, and 3 with very low quality.  The pooled estimate for the AOFAS score demonstrated non-significant differences at 1 month (p = 0.4) and 3 months (p = 0.076).  At 6 months (p = 0.009) and 12 months (p = 0.009), it indicated significant differences in favor of PRP.  The pooled estimate for VAS demonstrated non-significant differences at 1 month (p = 0.653).  At 3 months (p = 0.0001), 6 months (p = 0.002), and 12 months (p =0 .019), it yielded significant differences in favor of PRP.  The authors concluded that the findings of this systematic review and meta-analysis suggested that PRP was superior to corticosteroid injections for pain control at 3 months and lasted up to 1 year.  In the short-term, there was no advantage of corticosteroid infiltration.  Moreover, these researchers stated that the low study quality, high risk of bias, and different protocols for PRP preparation reduced the internal and external validity of these findings, and these results must be viewed with caution.

Radiofrequency Lesioning

In a prospective, comparative study, Osman and colleagues (2016) evaluated the effect of applying pulsed radiofrequency (PRF) for 6 minutes versus thermal radiofrequency (TRF) for 90 seconds to the medial calcaneal nerve for treatment of chronic refractory plantar fasciitis pain. A total of 20 patients with refractory chronic bilateral plantar fasciitis received PRF to the medial calcaneal nerve for 6 minutes for 1 heel and TRF to the same nerve on the other heel (as their own control) for 90 seconds.  Numerical verbal rating scale (NVRS) at waking up from bed and after prolonged walking, and satisfaction score were used for assessment of studied patients at 1, 3, 6, 12, and 24 weeks from the intervention.  All studied patients showed significant improvement in their pain scale after the intervention that lasted for 24 weeks; however, the PRF heels had significantly better pain scale and satisfaction scores at the 1st and 3rd weeks assessments when compared to the TRF heels.  Effective analgesia was achieved after 1 week or less after PRF compared to 3 weeks for the TRF (p < 0.001).  The authors concluded that PRF to the medial calcaneal nerve is a safe and effective method for treatment of chronic plantar fasciitis pain.  The onset of effective analgesia can be achieved more rapidly with PRF compared to TRF on the same nerve.  Moreover, they stated that further randomized trials are needed to confirm the therapeutic effect and optimizing the dose of RF needed.

In a retrospective, comparative study, Erden and colleagues (2021) examined the effectiveness of CSI, ESWT, and radiofrequency thermal lesioning (RTL) treatments in chronic plantar heel pain that has been unresponsive to other conservative treatments.  These researchers analyzed the results of 217 patients treated with CSI (n = 73), ESWT (n = 75), and RTL (n = 69).  The treatment effectiveness and pain intensity, as measured using the VAS, were recorded and compared at the 6-month follow-up.  Pain intensity decreased significantly in all patients; however, it decreased significantly more in the CSI and RTL groups than in the ESWT group (p < 0.001).  Age, sex, BMI, calcaneal spur presence, and symptom duration were similar among 3 groups (p > 0.05).  No complications were observed following the CSI, ESWT, or RTL sessions.  The authors concluded that CSI, ESWT, and RTL successfully treated chronic plantar heel pain that did not respond to other conservative treatments; however, CSI and RTL yielded better therapeutic outcomes.  Level of evidence = III.

Acupuncture

In a systematic review, Thiagarajah (2017) determined the effectiveness of acupuncture in reducing pain due to plantar fasciitis. Online literature searches on the PubMed and Cochrane Library databases were done for studies on the use of acupuncture for pain due to plantar fasciitis.  Studies designed as RCTs and which compared acupuncture with standard treatments or had real versus sham acupuncture arms were selected.  The Delphi List was used to assess the methodological quality of the studies retrieved.  A total of 3 studies that compared acupuncture with standard treatment and 1 study on real versus sham acupuncture were found.  These showed that acupuncture significantly reduced pain levels in patients with plantar fasciitis, as measured on the VAS and the Plantar Fasciitis Pain/Disability Scale.  These benefits were noted between 4 and 8 weeks of treatment, with no further significant reduction in pain beyond this duration.  Side effects were found to be minimal.  The authors concluded that although acupuncture may reduce plantar fasciitis pain in the short-term, there is insufficient evidence for a definitive conclusion regarding its effectiveness in the longer term.  They stated that further research is needed to strengthen its acceptance among healthcare providers.

An UpToDate review on “Plantar fasciitis” (Buchbinder, 2016) lists ESWT, cryosurgery, autologous whole blood or PRP injections, botulinum toxin injection, low-level laser therapy, and radiotherapy as unproven treatments. Furthermore, it does not mention acupuncture as a therapeutic option.

Extracorporeal Shock Wave Therapy

Sun and associates (2017) performed a meta-analysis to compare the efficacy of general ESWT, focused shock wave (FSW), and radial shock wave (RSW) with placebo, to assess their effectiveness in chronic PF.  The PubMed, Medline, EmBase, Web of Science, and Cochrane library databases were searched for studies comparing FSW or RSW therapy with placebo in chronic PF.  Clinical outcomes included the odds ratios (ORs) of pain relief, pain reduction, and complications.  Relevant data were analyzed using RevMan v5.3.  A total of 9 studies involving 935 patients were included; ESWT had higher improvement rates than the placebo group (OR 2.58, 95 % CI: 1.97 to 3.39, p < 0.00001); ESWT had markedly lower standardized mean difference than placebo, with heterogeneity observed (SMD 1.01, 95 % CI: -0.01 to 2.03, p = 0.05, I = 96 %, p < 0.00001).  FSW and RSW therapies had greater therapeutic success in pain relief than the placebo group (OR 2.17, 95 % CI: 1.49 to 3.16, p < 0.0001; OR 4.63, 95 % CI: 1.30 to 16.46, p = 0.02), but significant heterogeneity was observed in RSW therapy versus placebo (I = 81 %, p = 0.005).  The authors concluded that this meta-analysis suggested that FSW therapy can relieve pain in chronic PF as an ideal alternative option; meanwhile, no firm conclusions of general ESWT and RSW effectiveness can be drawn.  Moreover, they stated that due to variations in the included studies, additional trials are needed to validate these conclusions.

Salvioli and colleagues (2017) stated that plantar heel pain is one of the most common causes of pain and musculoskeletal pathologies of the foot.  These researchers identified the most effective, conservative and non-pharmacological treatments regarding pain in patients with plantar heel pain.  They searched 5 databases and included only RCTs that examined the efficacy of a conservative, non-pharmacological treatment compared to the placebo, for the outcome of pain.  Study selection, data collection and risk of bias assessment were conducted independently by 2 authors, and consensus was reached with a 3rd author.  Results were quantitatively summarized in meta-analyses, by separating homogeneous subgroups of trials by type of intervention.  A total of 20 studies that investigated the efficacy of 9 different types of interventions were included, with a total of 4 meta-analyses carried out.  The interventions: shock waves, laser therapy, orthoses, pulsed radiofrequency, dry-needling, and calcaneal taping resulted in being effective treatments for the outcome pain in patients with plantar heel pain when compared to the placebo.  However, the authors stated that considering that the improvements were very small, and the quality of evidence was mostly low or moderate for many of the interventions, it was not possible to give definitive conclusions for clinical practice.

Local Ozone (O2-O3) Injection

In a randomized clinical trial, Babaei-Ghazani and colleagues (2019) compared the effects of ozone (O2-O3) injection to corticosteroid injection (CSI) under US-guidance for the treatment of patients with chronic PF (n = 30).  Subjects were randomly divided into 2 groups receiving methylprednisolone (n = 15) versus ozone (O2-O3; n = 15).  The following outcome measures were assessed before injection and then 2 weeks and 12 weeks after the injection in each group; morning and daily pain via VAS, daily life and exercise activities via the Foot and Ankle Ability Measure, and plantar fascia thickness at insertion and 1 cm distal to its insertion into the calcaneus via US imaging.  Intra-group changes showed significant improvement in pain, functional parameters, and sonographic findings in both groups (p < 0.05).  Pain reduction (both daily and morning) and daily activity improvement were better in the corticosteroid group 2 weeks after injection; however, at 12 weeks, the ozone (O2-O3) group had significantly more improvement (p = 0.003, p = 0.001, and p = 0.017, respectively).  The authors concluded that both methods were effective in the treatment of chronic PF; CSI provided a more rapid and short-term therapeutic effect.  However, ozone (O2-O3) injection results in a slow and longer-lasting treatment outcome.  This was a small (n = 15 for the ozone group) with short-term follow-up (12 weeks).  These preliminary findings need to be validated by well-designed studies.

Neural Therapy (Injection of Local Anesthetics)

In a case-report, Fleckenstein and colleagues (2018) examined the role of inflammation as a contributor to pain in plantar fasciitis and its cure by neural therapy (injection of local anesthetics).  This was a case report on a 24-year old man, a middle-distance runner, with chronic unilateral plantar fasciitis and perceived heel pain for almost 1.5 years.  He was treated with neural therapy (injection of less than 1 ml procaine 1 % which is a local anesthetic with strong anti-inflammatory properties) of the surgical scar and along the surgical puncture channel.  The follow-up period from the time of 1st presentation until publication was 2.5 years.  At admission, pain intensity (VAS) in the affected leg was severe (10 cm, VAS; range of 0 to 10 cm) when walking and moderate (5 cm, VAS) when standing.  After the 1st session of injections the subject could stand pain-free and pain when walking was markedly reduced (- 90 %).  After the 3rd session, the subject reported no pain in the affected leg and could return to sports at his former level (no difference in training load compared to non-injured state).  There was no recurrence of inflammatory signs or heel pain despite intense athletics training up to the date of publication.  The authors concluded that in prolonged cases of plantar fasciitis, inflammation is an important component in the development of persistent pain.  The results of this case described the effects of 3 neural therapy sessions that abolished inflammation and associated heel pain.  They stated that neural therapy might be an effective and time-efficient approach in the treatment of plantar fasciitis, enabling an early return-to-sports.  These preliminary observations need to be validated by well-designed studies.

Piezoelectric Focal Waves Application

Vaamonde-Lorenzo and colleagues (2019) evaluated the effectiveness of Piezoelectric focal Shock waves with echographic support in the treatment of PF.  A total of 90 patients, 36.6 % men and 63.3 % women, with a mean age of 52 years, diagnosed with PF enrolled in this trial; 3 sessions (1 weekly for 3 weeks) of shock wave therapy (PiezoWave F10 G4 generator) were performed, with echographic support and weekly revision and at 3 and 6 months.  Main outcome measures were pain, using VAS before and after each session and at 3 and 6 months and Roles and Maudsley Scale at the end of treatment and at 3 and 6 months.  A total of 2,000 pulses per session were applied, medium energy intensity 0.45 mJ/mm2, median frequency 8 MHz and median depth of focus of 15 mm.  Statistically significant improvement was observed in the VAS between the 3 treatment sessions and after 3 and 6 months post-treatment, obtaining a statistically significant improvement in all values (p < 0.05).  The authors concluded that treatment with piezoelectric focal shock waves in PF may reduce pain from the 1st session and achieved a subjective perception of improvement, maintaining these results at 6 months post -treatment.  These preliminary findings need to be validated by well-designed studies with larger sample sizes and longer follow-up.

Low-Level Laser Therapy

Jastifer et al (2014) stated that a newly emerging technology, low-level laser therapy (LLLT), has demonstrated promising results for the treatment of acute and chronic pain.  In a prospective study examining the effects of LLLT for the treatment of chronic plantar fasciitis, a total of 30 patients were administered LLLT and completed 12 months of follow-up.   Patients were treated twice-weekly for 3 weeks for a total of 6 treatments and were evaluated at baseline, 2 weeks post-procedure, and 6 and 12 months post-procedure.  Patients completed the VAS and Foot Function Index (FFI) at study follow-up periods.  Patients demonstrated a mean improvement in heel pain VAS from 67.8 out of 100 at baseline to 6.9 out of 100 at the 12-month follow-up period.  Total FFI score improved from a mean of 106.2 at baseline to 32.3 at 12 months post-procedure.  The authors concluded that although further studies are warranted, this study showed that LLLT is a promising treatment of chronic plantar fasciitis.

Wang and colleagues (2019) noted that emerging evidence suggested that LLLT for PF may be beneficial.  However, the convincing study examining its effectiveness for treatment of PF was scarce.  In a systematic review and meta-analysis, these investigators examined if LLLT significantly relieve pain of patients with PF.  PubMed, Embase, Ebsco, Web of Science, China Biological Medicine Database, China National Knowledge Infrastructure, Chinese Wan fang, and Cochrane CENTRAL were searched systematically up to March 2018.  A total of 6 RCTs were included.  The meta-analysis indicated that compared with control group, VAS score significantly decreased at the end-point of the treatment in LLLT group.  Furthermore, this improvement was continued for up to 3 months.  However, no significant difference was observed according to the Foot Function Index-pain subscale (FFI-p).  The authors concluded that the findings of this meta-analysis indicated that the LLLT in patients with PF significantly relieved the heel pain and the excellent efficacy lasted for 3 months following treatment.  Moreover, these researchers stated that further large-scale, well-designed studies are needed to clarify long-term efficacy and optimal treatment parameters of LLLT.

The authors stated that this systematic review and meta-analysis had several drawbacks.  First, only 6 studies were included, and sample size was relatively small.  Second, this meta-analysis lacked sufficient evidence to analyze the underlying influence factors (such as BMI) that may influence the effect of LLLT treatment.  Third, the included studies lacked sufficient data regarding longer-term outcomes of LLLT.  Thus, this study provided only relevant short-term (up to 3 months) comparison data.  Finally, the outcome obtained was just based on VAS, and other objective indices (such as heel tenderness index and PF thickness) were not universally used in all included studies.

The Graston Technique (Instrument-Assisted Soft-Tissue Mobilization)

Cheatham and associates (2016) stated that instrument-assisted soft tissue mobilization (IASTM) is a popular treatment for myofascial restriction.  IASTM uses specially designed instruments to provide a mobilizing effect to scar tissue and myofascial adhesions.  Several IASTM tools and techniques are available such as the Graston technique.  Currently, there are no systematic reviews that have specifically appraised the effects of IASTM as a treatment or to enhance joint range of motion (ROM).  These researchers examined the current evidence on the effects of IASTM in the treatment of a musculoskeletal pathology or enhancement of joint ROM.  A search of the literature was conducted in December 2015 that included the following databases: PubMed, PEDro, Science Direct, and the EBSCOhost collection.  A direct search of known journals was also conducted to identify potential publications.  The search terms included individual or a combination of the following: instrument; assisted; augmented; soft-tissue; mobilization; Graston; and technique.  A total of 7 RCTs were appraised; 5 of the studies measured an IASTM intervention versus a control or alternate intervention group for a musculoskeletal pathology.  The results of the studies were insignificant (p > 0.05) with both groups displaying equal outcomes; 2 studies measured an IASTM intervention versus a control or alternate intervention group on the effects of joint ROM.  The IASTM intervention produced significant (p < 0.05) short-term gains up to 24 hours.  The authors concluded that the available evidence of RCTs did not support the efficacy of IASTM for treating certain musculoskeletal pathologies.  There was weak evidence supporting the efficacy of IASTM for increasing lower extremity joint ROM for a short period of time.  These researchers stated that IASTM is a popular form of myofascial therapy but its efficacy has not been fully determined due to the paucity and heterogeneity of evidence.  There is a gap between the current research and clinical practice.  A consensus has not been established regarding the optimal IASTM program, type of instrument, dosage time, and outcomes measures.  Future studies are needed to assess the different IASTM tools and IASTM protocols such as Graston technique using strict methodology and fully powered controlled trials.  The current evidence appeared to lack the methodological rigors needed to validate the efficacy of IASTM itself or any of the IASTM protocols.

In a pilot study, Jones and colleagues (2019) examined feasibility of treatment with IASTM, using the Graston technique, compared with conservative care for treatment of chronic plantar heel pain (CPHP).  A total of 11 patients with plantar heel pain lasting 6 weeks to 1 year were randomly assigned to 1 of 2 groups, with each group receiving up to 8 physical therapy visits.  Both groups received the same stretching, exercise, and home program, but the experimental group also received IASTM using the Graston technique.  Outcome measures of pain and function were recorded at baseline, after final treatment, and 90 days later.  Feasibility of a larger study was determined considering recruitment and retention rates, compliance, successful application of the protocol and estimates of the treatment effect.  Both groups demonstrated improvements in current pain (pain at time of survey), pain with the first step in the morning, and function after final treatment and at 90-day follow up.  Medium-to-large effect sizes between groups were noted, and sample size estimates demonstrated a need for at least 42 subjects to realize a group difference.  A larger-scale study was determined to be feasible with modifications including a larger sample size and higher recruitment rate.  The authors concluded that the findings of this pilot study demonstrated that inclusion of IASTM using the Graston technique for CPHP lasting longer than 6 weeks is a feasible intervention warranting further study.  Clinically important changes in the IASTM group and moderate-to-large between-group effect sizes suggested that further research is needed to examine if these trends are meaningful.  These researchers stated that future studies should include larger sample sizes, as demonstrated by the power analysis calculations, to allow for more advanced statistical analysis and further clarification of the efficacy of this treatment.

The authors stated that one main drawback of this study was the small sample size (n = 11).  Power analyses using the between-group effect sizes demonstrated that future studies should include a sample size of at least 42 subjects to allow for advanced statistical analysis to demonstrate significant differences in these outcomes.  Given that the effect size calculations and sample size estimations reflected a small and variable sample, further research can determine whether these estimates will demonstrate a true difference between groups receiving these interventions.  The intent of this pilot study focused on the feasibility of including IASTM as an intervention for the management of CPHP.  The findings suggested that further research is needed to determine the efficacy of this intervention.  Although outcomes using the study interventions appeared to be meaningful for the patient, a primary concern specific to study protocol entailed the recruitment rate.  The present study recruited fewer than 1 subject per month, which is not feasible for a larger, more powerful study.  The estimated sample size needed (n = 42) to further examine this intervention with this population is not unrealistic but would require more treatment sites and a higher recruitment rate to be successful.  Another drawback of this pilot study was the use of 3 clinicians providing treatment at multiple clinical sites.  Although all of the clinicians used in this study were licensed, trained, and certified, there may have been inter-clinician differences in application of the Graston technique.  Cheatham et al (2016) noted in their systematic review that optimal protocols have yet to be established in the literature for this treatment approach.  To allow for the consistent application of the Graston technique in this pilot study, the treatment procedures used by all 3 clinicians were based on recommendations by the manufacturer of the Graston tools.

The TENEX Procedure (Ultrasound-guided Percutaneous Fasciotomy / Tenotomy)

Debrule (2010) stated that chronic PF is often treated by surgical plantar fasciotomy when conservative treatments have been exhausted.  The author presented an ultrasound (US)-guided Weil percutaneous plantar fasciotomy technique that was used to successfully treat persistent plantar fasciitis in a 48-year old woman.  Five weeks after the procedure, the patient had resumed normal activity, with an excellent clinical outcome.  The author concluded that this US-guided technique could be performed in an office or hospital setting; this technique may be useful to podiatric physicians and surgeons who treat chronic PF.  This was a single-case study with short-term follow-up (5 weeks); its findings need to be validated by well-designed studies.

Langar (2015) noted that some common overuse injuries, such as Achilles tendinopathy and PF (or fasciopathy), can be refractory to treatment.  When standard therapeutic options fail, operative intervention often becomes the treatment of last resort.  Recently, newer technologies have been developed and refined, and can provide potential benefits for these conditions using non-invasive and minimally invasive approaches.  Two technologies, ESWT and US-guided percutaneous fasciotomy/tenotomy were discussed.

Patel (2015) conducted a prospective study in which patients with refractory PF were allowed either to continue with non-invasive treatment or to undergo focal aspiration and partial fasciotomy with an US probe.  These researchers stated that this was the 1st report of a plantar fascia partial release guided by US energy delivered by a percutaneously inserted probe under local anesthesia.  The author concluded that the procedure appeared to be a safe, effective, well-tolerated treatment for a condition that is refractory to other options.

An UpToDate review on “Plantar fasciitis” (Buchbinder, 2020) states that “While numerous surgical procedures have been described, almost none have been assessed in randomized trials.  Favorable outcomes are reported in more than 75 %of published case series, although recovery time may be prolonged and persistent pain is not uncommon.  Variations of open or endoscopic, partial or complete, plantar fascia release with or without calcaneal spur resection, excision of abnormal tissue, and nerve decompression have been described.  A small trial compared endoscopic deep versus superficial fasciotomy and reported better early postoperative function scores and fewer adverse events in the superficial fasciotomy group; however, the functional scores at 1 year were similar”.  Moreover, this review does not mention the Tenex procedure / ultrasound-guided percutaneous fasciotomy/tenotomy as a therapeutic option.

Combined Dry Needling and Extracorporeal Shock Wave Therapy

Bagcier and Yilmaz (2020) examined the effectiveness of combined dry needling (DN) and ESWT on pain and functionality in plantar fasciitis.  A total of 40 patients who were clinically diagnosed with plantar fasciitis were included in the study; subjects were randomly divided into 2 groups.  The DN-ESWT group was administered 3 sessions of ESWT to plantar fascia and DN to the trigger points in the gastro-soleus muscles.  The ESWT group was given only ESWT treatment to plantar fascia.  These researchers used VAS for pain and a pressure algometer for pressure pain threshold.  The functionality of the patients was evaluated with FFI.  Furthermore, maximum painless standing time and maximum painless walking distance were recorded.  All evaluations were repeated twice; first, pre-treatment; and second, 1-month post-treatment.  In both groups, there were statistically significant improvements in VAS, pressure pain threshold, maximum painless standing time, maximum painless walking distance, and FFI's pain, disability, and activity limitation subscales scores (p ≤ 0.001).  In intergroup comparison; it was showed that VAS scores, maximum painless standing time (p = 0.002), maximum painless walking distance (p ≤ 0.001), and FFI pain subscale scores (p = 0.034) were statistically superior in the DN-ESWT group.  There was no statistically difference between the groups in pressure pain threshold (p = 0.132), FFI disability (p = 0.081), and FFI activity limitation subscale (p = 0.226) scores.  DN and ESWT combination therapy in plantar fasciitis was found to be superior in the pain scores.  The authors concluded that further studies with larger patients' groups and longer-term results of this combination are needed for a better comparison.

Kinesio Taping

In a randomized, single-center trial, Tezel and colleagues (2020) compared the effectiveness of Kinesio taping (KT) with ESWT in the management of plantar fasciitis.  A total of 84 patients with plantar fasciitis were enrolled and randomized into KT and ESWT treatment groups in a 1:1 ratio (i.e., 42 patients in each group); only 1 foot was considered for each patient.  Both KT and ESWT were applied once-weekly for 6 weeks.  Patients' pain, functional status and QOL were evaluated with the VAS, FFI and the Short-Form-36 (SF-36) health survey, respectively.  Patients' fat pat and plantar fascia thickness were measured using ultrasonography.  All evaluations were performed before and immediately after the 6-week intervention.  In the KT group, 6 patients were lost to follow-up; thus, the final analysis only included 36 patients.  After the intervention, there was a statistically significant improvement in the VAS and SF-36 scores of both groups (p = 0.001), but the FFI score improvement was statistically significant only in the KT group (p = 0.001).  In both groups, the mean thickness of plantar fascia decreased after treatment and the mean thickness of the fat pat increased; however, the change was not statistically significant (p = 0.935 and p = 0.832, respectively).  The authors concluded that both KT and ESWT treatments improved pain levels and QOL in patients with plantar fasciitis; however, KT also improved functionality.  Moreover, these researchers stated that further multi-center studies with larger sample size , longer follow-ups and inclusion of methods that detect biomechanical changes are needed to validate these findings.

The authors stated that a drawback of this study was that the absence of a 3rd third group that included exercise therapy only.  Furthermore, these findings may be limited because the trial was carried out at a single center and the biomechanics of the foot, such as foot plantar pressure analysis, was not evaluated.

TenJet System

Wong and colleagues (2018) stated that during acute inflammatory phases of tendinopathy, a combination of physical therapy and corticosteroid injections is considered to be moderately effective for acute inflammation; however, surgical debridement of tendinopathic tissues is often needed for chronic cases.  The TenJet system created by HydroCision, Inc. is a percutaneous device that uses high-pressure saline to debride pathologic tissues during tenotomy.  These researchers employed a collagenase-induced tendinopathy model on explants from bovine ankle extensor tendons.  They used the volume of defect debrided as a metric to determine the effectiveness of using high-velocity fluid flow as a debridement tool as well as the effect of velocity magnitude on efficacy.  Furthermore, the authors highlighted the negligible disruption of healthy tissue surrounding pathologic tissue.

Table: CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":
CPT codes covered if selection criteria are met:
29893	Endoscopic plantar fasciotomy
CPT codes not covered for indications listed in the CPB:
Low-Level Laser Therapy, Micronized dehydrated amniotic/chorionic membrane allograft, piezoelectric focal waves application, Graston technique (instrument-assisted soft-tissue mobilization), TENEX procedure - no specific code:
0232T	Injection(s), platelet rich plasma, any tissue, including image guidance, harvesting and preparation when performed
0481T	Injection(s), autologous white blood cell concentrate (autologous protein solution), any site, including image guidance, harvesting and preparation, when performed
20552	Injection(s); single or multiple trigger point(s), 1 or 2 muscle(s)
20553	Injection(s); single or multiple trigger point(s), 3 or more muscle(s)
20560	Needle insertion(s) without injection(s); 1 or 2 muscle(s) [dry needling]
20561	3 or more muscles [dry needling]
27687	Gastrocnemius recession (e.g., Strayer procedure)
28890	Extracorporeal shock wave, high energy, performed by a physician or other qualified healthcare professional, requiring anesthesia other than local, including ultrasound guidance, involving the plantar fascia
64642 - 64645	Chemodenervation of one extremity
77401 - 77417	Radiation treatment delivery
97035	Application of a modality to 1 or more areas; ultrasound, each 15 minutes
97810 - 97814	Acupuncture without/with electrical stimulation
Other CPT codes related to the CPB:
28008	Fasciotomy, foot and/or toe [not covered when guided by ultrasonic energy]
28060	Fasciectomy, plantar fascia; partial (separate procedure) [not covered when guided by ultrasonic energy]
28062	radical (separate procedure) [not covered when guided by ultrasonic energy]
28250	Division of plantar fascia and muscle (eg, Steindler stripping) (separate procedure) [not covered when guided by ultrasonic energy]
HCPCS codes not covered for indications listed in the CPB:
Kinesio Tex taping, local ozone (O2-O3) injection, TenJet system - no specific code:
C9290	Injection, bupivacaine liposome, 1 mg
E0761	Non-thermal pulsed high frequency radiowaves, high peak power electromagnetic energy treatment device
E0769	Electrical stimulation or electromagnetic wound treatment device, not otherwise classified
G6001 - G6014	Radiation treatment delivery
J0585	Injection, onabotulinumtoxina A, 1 unit
J0586	Injection, abolotulinumtoxina A, 5 units
J0587	Injection, rimabotulinumtoxin B, 100 units
J0588	Injection, incobotulinumtoxin A, 1 unit
J1030	Injection, methylprednisolone acetate, 40 mg
J2001	Injection, lidocaine HCl for intravenous infusion, 10 mg
P9020	Platelet rich plasma, each unit
Q4139	Amniomatrix or biodmatrix, injectable, 1 cc
Q4155	Neoxflo or clarixflo 1 mg
S8948	Application of modality (requiring constant provider attendance) to one or more areas; low-level laser; each 15 minutes
Other HCPCS codes related to the CPB:
A4570	Splint
L3000 - L3265	Orthopedic shoes
L3300 - L3649	Shoe modifications
L4350 - L4398	Splint, ankle, foot, leg
S8451	Splint, prefabricated, wrist or ankle
ICD-10 codes covered if selection criteria are met:
M72.2	Plantar fascial fibromatosis
M77.30 - M77.32	Calcaneal spur

The above policy is based on the following references: