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

2. 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 OrthospecTM Extracorporeal Shock Wave Therapy (Medispec, Ltd., Germantown, MD), or any other ESWT devices experimental and investigational for plantar fasciitis. 

3. Aetna considers radiofrequency lesioning, radiotherapy, marrow stimulation techniques ( microfracture, drilling), or cryosurgery (cryotherapy) experimental and investigational for members with plantar fasciitis.  There is a lack of published literature documenting the safety and efficacy of these techniques in the treatment of plantar fasciitis.  

Note: 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. See CPB 451 - Foot Orthotics.  

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, 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.  ESWT 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, 3800 shock waves are delivered over 20 minutes.

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 six months and a history of prior conservative therapy (including NSAIDs and two 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 three 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 three 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 (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, 1500 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 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 four following criteria: 1) investigator assessment of heel pain, with positive response defined as greater than 50 percent 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 percent 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 percent of the OssaTron-treated patients and 30 percent 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 two endpoints -- self-assessment of activity and use of pain medications -- were not statistically different between the two groups.

Side effects of Ossatron ESWT included nerve complications (nerve irritation, numbness) in 6 patients and plantar fascial tears in two 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 & Strayer (2002) stated:

Extracorporeal 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 one dozen systematic evidence reviews, including those from national and international authorities (including the Cochrane Collaboration (Crawford & Thomson, 2003), BMJ Clinical Evidence (Landorf & 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), 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 (see, e.g., Cole, et al., 2005; Buchbinder, 2004; Burton & Overend, 2005; Boddeker, et al., 2004; 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 extracorporeal shock wave therapy 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 randomised 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) reassessed extracorporeal shock wave therapy for plantar fasciitis, and reversed position on the effectiveness of this therapy.  The 2003 TEC assessment stated: "In 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 reaffirmed 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 two 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 two 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 minutes of walking in the morning between the two groups.  There are also no differences in AOFAS and SF-12 health status questionnaire scores between the two groups.  In addition, it is of note that there were no differences in Roles and Maudsley Score at 6-week follow-up between the two 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 30-50% 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 nine 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 two good quality studies found no evidence for benefit compared with sham ESWT.  

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: "Current 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 Calilfornia Technology Assessment Forum (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 fourteen 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, two of the three good quality studies found no evidence for benefit compared with sham ESWT.

Tornese and co-workers (2008) compared two 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 two groups at 2 and 8 months follow-up.  The authors concluded that there was no difference between the two 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); 2000 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 are to be compared: (i) standard arm -- total dose 6.0 Gy in single fractions of 1.0 Gy applied twice-weekly, and (ii) 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.