Mechanical Stretching Devices for Contracture and Joint Stiffness

Number: 0405

Policy

Dynamic Splinting Devices

Aetna considers dynamic splinting devices for the knee, elbow, wrist, finger, or toe medically necessary durable medical equipment (DME) if either of the following two selection criteria is met:

1. As an adjunct to physical therapy in members with documented signs and symptoms of significant motion stiffness/loss in the sub-acute injury or post-operative period (i.e., at least 3 weeks after injury or surgery); or
2. For members who have a prior documented history of motion stiffness/loss in a joint, have had a surgery or procedure done to improve motion to that joint, and are in the acute post-operative period following a second or subsequent surgery or procedure.

Note: Dynamic splinting systems include, but are not limited to, such products as Advance Dynamic ROM, Dynasplint, EMPI Advance Dynamic ROM, LMB Pro-glide, Pro-glide Dynamic ROM, SaeboFlex, SaeboReach, Stat-A-Dyne, and Ultraflex.

Note: The SaeboMas dynamic mobile arm support system is considered experimental and investigational because of insufficient published evidence of its clinical value.

Aetna considers the prophylactic use of dynamic splinting experimental and investigational in the management of chronic contractures (no significant change in motion for a 4-month period) and joint stiffness due to joint trauma, fractures, burns, head and spinal cord injuries, rheumatoid arthritis, multiple sclerosis, muscular dystrophy or cerebral palsy because of insufficient evidence in the peer-reviewed literature.  However, if surgery is being performed for a “chronic” condition, the use of a dynamic splinting system may be considered medically necessary if the member meets the selection criteria stated above.

Aetna considers the use of dynamic splinting experimental and investigational for the following indications (not an all-inclusive list) because there is a lack of scientific evidence regarding its effectiveness for these indications:

• Carpal tunnel syndrome
• Cerebral palsy
• Foot drop associated with neuromuscular diseases
• Hallux valgus
• Head and spinal cord injuries
• Improvement of outcomes following botulinum toxin injection for treatment of limb spasticity
• Injuries of the ankle, and shoulder 
• Multiple sclerosis
• Muscular dystrophy
• Plantar fasciitis
• Rheumatoid arthritis
• Stroke
• Trismus.

Flexionators and Extensionators

Aetna considers patient-actuated serial stretch (PASS) devices (e.g., the ERMI Knee/Ankle flexionator, the ERMI Shoulder flexionator, the ERMI Elbow extensionator, the ERMI Knee extensionator, the ERMI MPJ extensionator, JAS EZ (ankle, elbow, finger, knee extension, knee flexion, pronation/ supination, shoulder, toe and wrist), and knee extension devices (e.g., the Elite Seat) experimental and investigational because of insufficient scientific evidence of the effectiveness of these devices.

Joint Active Systems (JAS) Splints

Aetna considers JAS splints (e.g., JAS Elbow, JAS Shoulder, JAS Knee, JAS Wrist, and JAS Pronation-Supination) experimental and investigational because there is insufficient evidence in the peer-reviewed published medical literature concerning their effectiveness.

Aetna considers the use of the EZ Turnbuckle orthosis (JAS orthosis) after open reduction internal fixation (ORIF) for radial head fracture experimental and investigational because its effectiveness has not been established.

Dynamic Adjustable Ankle Extension/Flexion Device

Aetna considers dynamic adjustable ankle extension/flexion device (e.g., JAS Ankle) medically necessary for the treatment of contractures. See CPB 0565 - Ankle Orthoses, Ankle-Foot Orthoses (AFOs), and Knee-Ankle-Foot Orthoses (KAFOs).

Medi-Dyne Prostretch Device

Aetna considers the Medi-Dyne Prostretch device experimental and investigational because of a lack of evidence regarding its effectiveness.

Background

Mechanical stretching devices differ from continuous passive motion devices in that they are nonmotorized and include the following types: low-load prolonged-duration stretch (LLPS) devices, patient-actuated serial stretch (PASS) devices and static progressive stretch (SPS) devices. Mechanical stretching devices are generally proposed as an adjunct treatment to PT and/or exercise.

• LLPS devices, also referred to as dynamic splinting, permit active and passive motion with elastic traction within a limited range and maintain a set level of tension by means of incorporated springs. Examples of LLPS devices include, but may not be limited to, Advance Dynamic ROM, Dynasplint, EMPI Advance Dynamic ROM, Proglide Advance Dynamic ROM, LMB Pro-Glide, SaeboFlex, SaeboReach, Stat-A-Dyne and Ultraflex.
• PASS devices are purported to permit active and passive motion with elastic traction within a limited range, but also provide a low- to high-level load to the joint using pneumatic, hydraulic or tensioning systems that can be adjusted by the individual. Examples of PASS devices include, but may not be limited to, Elite Seat, ERMI Elbow Extensionater, ERMI Knee Extensionater, ERMI Knee/Ankle Flexionater and ERMI Shoulder Flexionater, JAS EZ Systems (ankle, elbow, finger, knee extension, knee flexion, pronation/supination, shoulder, toe and wrist).
• SPS devices hold the joint in a set position but are purported to allow for manual modification of the joint angle without exerting stress on the tissue unless the angle is set to the joint’s limitations. While these devices allow for movement (passive or active) within a limited range, the motion is free and does not provide elastic traction. Examples of SPS devices include, but may not be limited to, Joint Active Systems (JAS) Splints (eg, JAS Ankle, JAS Elbow, JAS Knee, JAS Pronation-Supination, JAS Shoulder, JAS Wrist). 
• Jaw mobility mechanical stretching devices are suggested for use in the treatment of temporomandibular joint (TMJ) disorders, trismus or other conditions in which jaw movement is limited. Examples of this type of mechanical stretching device include, but may not be limited to, TheraBite Jaw Motion Rehabilitation System, Dynasplint Trismus System or Orastretch.

Dynamic Splinting Systems

Dynamic splinting systems are spring-loaded, adjustable devices designed to provide low-load prolonged stretch while patients are asleep or at rest.  Dynamic splinting units (for both extension as well as flexion) are available for elbow, wrist, fingers, knee, ankle and toes.  These units are being marketed for the treatment of joint stiffness due to immobilization or limited range of motion (ROM) as a consequence of fractures, dislocations, tendon and ligament repairs, joint arthroplasties, total knee replacements, burns, rheumatoid arthritis, hemophilia, tendon releases, head trauma, spinal cord injuries, cerebral palsy (CP), multiple sclerosis, and other traumatic and non-traumatic disorders.

Dynamic splinting is commonly used in the post-operative period for the prevention or treatment of motion stiffness/loss in the knee, elbow, wrist or finger.  It is not generally used in other joints such as the hip, ankle or foot.

Product names commonly encountered on the market for dynamic splinting include: Dynasplint™, Ultraflex™, LMB Pro-glide™, EMPI Advance™ and SaeboFlex™.

The SaeboFlex has been promoted for use in rehabilitation in persons with hemiplegia following cerebrovascular accident.  However, there is no peer-reviewed published medical literature of the effectiveness of the device for this indication.

Goodyear-Smith and Arroll (2004) undertook a literature review to produce evidence-based recommendations for non-surgical family physician management of carpal tunnel syndrome (CTS).  These investigators assessed 2 systematic reviews, 16 randomized controlled trials, and 1 before-and-after study using historical controls.  A considerable percentage of CTS resolves spontaneously.  There is strong evidence that local corticosteroid injections, and to a lesser extent oral corticosteroids, give short-term relief for CTS sufferers.  There is limited evidence to indicate that splinting, laser-acupuncture, yoga, and therapeutic ultrasound may be effective in the short-to-medium term (up to 6 months).

Graham et al (2004) evaluated the role of steroid injections combined with wrist splinting for the management of CTS.  A total of 73 patients with 99 affected hands were studied.  Patients presenting with known medical causes or muscle wasting were excluded.  Diagnosis was made clinically and electrodiagnostic studies were performed only when equivocal clinical signs were present.  Each patient received up to 3 betamethasone injections into the carpal tunnel and wore a neutral-position wrist splint continuously for 9 weeks.  After that period, symptomatic patients received an open carpal tunnel release, and those who remained asymptomatic were followed-up regularly for at least 1 year.  Patients who relapsed were scheduled for surgery.  At a minimum follow-up of 1 year, 7 patients (9.6 %) with 10 affected hands (10.1 %) remained asymptomatic.  This group had a significantly shorter duration of symptoms (2.9 months versus 8.35 months; p = 0.039, Mann-Whitney test) and significantly less sensory change (40 % versus 72 %; p = 0.048, Fisher's exact test) at presentation when compared with the group who had surgery.  It is concluded that steroid injections and wrist splinting are effective for relief of CTS symptoms; but have a long-term effect in only 10 % of patients.

In a systematic review, Larson and Jerosch-Herold (2008) examined the clinical effectiveness of post-operative splinting after surgical release of Dupuytren's contracture.  Studies were included if they met the following inclusion criteria: prospective or retrospective, experimental, quasi-experimental or observational studies investigating the effectiveness of static or dynamic splints worn day and/or night-time for at least 6 weeks after surgery and reporting either individual joint or composite finger range of motion and/or hand function.  The methodological quality of the selected articles was independently assessed by the two authors using the guidelines for evaluating the quality of intervention studies developed by McDermid.  Four studies, with sample sizes ranging from 23 to 268, met the inclusion criteria for the systematic review.  Designs included retrospective case review, prospective observational and one controlled trial without randomization.  Interventions included dynamic and static splinting with a mean follow-up ranging from 9 weeks to 2 years.  Pooling of results was not possible due to the heterogeneity of interventions (splint type, duration and wearing regimen) and the way outcomes were reported.  The authors concluded that there is empirical evidence to support the use of low-load prolonged stretch through splinting after hand surgery and trauma, however only a few studies have investigated this specifically in Dupuytren's contracture.  The low level evidence regarding the effect of post-operative static and dynamic splints on final extension deficit in severe PIP joint contracture (greater than 40 degrees) is equivocal, as is the effect of patient adherence on outcome.  While total active extension deficit improved in some patients wearing a splint, there were also deficits in composite finger flexion and hand function.  The lack of data on the magnitude of this effect makes it difficult to interpret whether this is of clinical significance.  There is a need for well-designed controlled trials with proper randomization to evaluate the short-term and long-term effectiveness of splinting following Dupuytren's surgery.

Foot drop usually refers to weakness or contracture of the muscles around the ankle joint.  It may arise from many neuromuscular diseases.  In a Cochrane review, Sackley and colleagues (2009) performed a systematic review of randomized trials for the treatment of foot drop resulting from neuromuscular disease.  Randomized and quasi-randomized trials of physical, orthotic and surgical treatments for foot drop resulting from lower motor neuron or muscle disease and related contractures were included.  People with primary joint disease were excluded.  Interventions included a "wait and see" approach, physiotherapy, orthoses, surgery and pharmacological therapy.  The primary outcome measure was quantified ability to walk while secondary outcome measures included range of motion (ROM), dorsiflexor torque and strength, measures of activity and participation, quality of life and adverse effects.  Methodological quality was evaluated by 2 authors using the van Tulder criteria.  Four studies with a total of 152 participants were included in the review.  Heterogeneity of the studies precluded pooling the data.  Early surgery did not significantly affect walking speed in a trial including 20 children with Duchenne muscular dystrophy.  Both groups deteriorated during the 12 months follow-up.  After 1 year, the mean difference (MD) of the 28-feet walking time was 0.00 seconds (95 % confidence interval [CI]: -0.83 to 0.83) and the MD of the 150-feet walking time was -2.88 seconds, favoring the control group (95 % CI: -8.18 to 2.42).  Night splinting of the ankle did not significantly affect muscle force or ROM about the ankle in a trial of 26 participants with Charcot-Marie-Tooth disease.  Improvements were observed in both the splinting and control groups.  In a trial of 26 participants with Charcot-Marie-Tooth disease and 28 participants with myotonic dystrophy, 24 weeks of strength training significantly improved 6-meter timed walk in the Charcot-Marie-Tooth group compared to the control group (MD 0.70 seconds, favoring strength training, 95 % CI: 0.23 to 1.17), but not in the myotonic dystrophy group (MD -0.20 seconds, favoring the control group, 95 % CI: -0.79 to 0.39).  No significant differences were observed for the 50-meter timed walk in the Charcot-Marie-Tooth disease group (MD 1.90 seconds, favoring the training group, 95 % CI: -0.29 to 4.09) or the myotonic dystrophy group (MD -0.80 seconds, favoring the control group, 95 % CI: -5.29 to 3.69).  In a trial of 65 participants with facio-scapulo-humeral muscular dystrophy, 26 weeks of strength training did not significantly affect ankle strength.  After 1 year, the mean difference in maximum voluntary isometric contraction was -0.43 kg, favoring the control group (95 % CI: -2.49 to 1.63) and the mean difference in dynamic strength was 0.44 kg, favoring the training group (95 % CI: -0.89 to 1.77).  The authors concluded that only 1 study, involving people with Charcot-Marie-Tooth disease, demonstrated a statistically significant positive effect of strength training.  No effect of strength training was found in people with either myotonic dystrophy or facio-scapulo-humeral muscular dystrophy.  Surgery had no significant effect in children with Duchenne muscular dystrophy and night splinting of the ankle had no significant effect in people with Charcot-Marie-Tooth disease.  They stated that more evidence generated by methodologically sound studies is needed.

In another Cochrane review, Rose et al (2010) evaluated the effect of interventions to reduce or resolve ankle equinus in people with neuromuscular disease.  Randomized controlled trials evaluating interventions for increasing ankle dorsiflexion ROM in neuromuscular disease.  Outcomes included ankle dorsiflexion ROM, functional improvement, foot alignment, foot and ankle muscle strength, health-related quality of life, satisfaction with the intervention and adverse events.  Two authors independently selected papers, assessed trial quality and extracted data.  Four studies involving 149 participants met inclusion criteria for this review.  Two studies assessed the effect of night splinting in a total of 26 children and adults with Charcot-Marie-Tooth disease type 1A.  There were no statistically or clinically significant differences between wearing a night splint and not wearing a night splint.  One study assessed the efficacy of prednisone treatment in 103 boys with Duchenne muscular dystrophy.  While a daily dose of prednisone at 0.75 mg/kg/day resulted in significant improvements in some strength and function parameters compared with placebo, there was no significant difference in ankle ROM between groups.  Increasing the prednisone dose to 1.5 mg/kg/day had no significant effect on ankle ROM.  One study evaluated early surgery in 20 young boys with Duchenne muscular dystrophy.  Surgery resulted in increased ankle dorsiflexion range at 12 months but functional outcomes favored the control group.  By 24 months, many boys in the surgical group experienced a relapse of achilles tendon contractures.  The authors concluded that there is no evidence of significant benefit from any intervention for increasing ankle ROM in Charcot-Marie-Tooth disease type 1A or Duchenne muscular dystrophy.  They stated that more research is needed.

In a pilot study, Postans and colleagues (2010) investigated the feasibility of applying the combination of dynamic splinting and neuromuscular electrical stimulation (NMES) in order to improve wrist and elbow function, and ROM, in children with upper limb contractures due to CP.  A total of 6 children aged 7 to 16, with contractures at the wrist or elbow, were recruited.  Following a 12-week baseline period all subjects underwent a 12-week treatment period where dynamic splinting was used for 1 hour per day and combined with NMES for the second half of the 1-hr treatment.  A 12-week follow-up period then ensued.  Upper limb function was assessed with the Melbourne assessment, physical disability with the Pediatric Evaluation of Disability Index and the Activity Scale for Kids, and quality of life with the Pediatric Quality of Life Scale.  Passive and active ROM at the wrist and elbow were measured using manual and electrical goniometers.  The technique of using combined NMES and dynamic splinting was demonstrated to be feasible and compliance with the intervention was good.  There was an increase in passive elbow extension in 2 subjects treated for elbow contractures, although no accompanying change in upper limb function was reported.  Wrist ROM improved in 1 subject treated for wrist contracture.  The findings of this pilot study need to be validated by well-designed studies.

John et al (2011) stated that hallux limitus (HL) is a pathology of degenerative arthritis in the first metatarsophalangeal joint (MTJ) of the great toe.  Chief complaints of HL include inflammation, edema, pain, and reduced flexibility.  The onset of HL commonly occurs after one of the two most common surgical procedures for foot pathologies, a bunionectomy or a cheilectomy.  These investigators determined the effectiveness of dynamic splinting in treating patients with post-operative hallux limitus, in a randomized, controlled trial.  A total of 50 patients (aged 29 to 69 years) were enrolled after diagnosis of HL following surgery.  The duration of this study was 8 weeks, and all patients received non-steroidal anti-inflammatory drugs, orthotics, and instructions for a home exercise program.  Experimental patients were also treated with dynamic splinting for first MTJ extension (60 mins, 3 times per day).  The dependent variable was change in active ROM (AROM).  A repeated measures analysis of variance was used with independent variables of patient categories, surgical procedure (cheilectomy versus bunionectomy) and duration since surgery.  There was a significant difference in change of AROM for experimental versus control patients (p < 0.001, T = 4.224, n = 48); there was also a significant difference for patient treated within 2 months of surgery (p = 0.0221).  The authors concluded that dynamic splinting was effective in reducing contracture of post-operative hallux limitus in this study; experimental patients gained a mean 250 % improvement in AROM.  This modality should be considered for standard of care in treating post-operative hallux limitus.

Sameem et al (2011) stated that controversy exists as to which rehabilitation protocol provides the best outcomes for patients after surgical repair of the extensor tendons of the hand.  These researchers determined which rehabilitation protocol yields the best outcomes with respect to ROM and grip strength in extensor zones V-VIII of the hand.  A comprehensive literature review and assessment was undertaken by 2 independent reviewers.  Methodological quality of randomized controlled trials (RCTs) and cohort studies was assessed using the Scottish Intercollegiate Guidelines Network scale.  A total of 17 articles were included in the final analysis (κ = 0.9).  From this total, 7 evaluated static splinting, 12 evaluated dynamic splinting, and 4 evaluated early active splinting.  Static splinting yielded "excellent/good" results ranging from 63 % (minimum) to 100 % (maximum) on the total active motion (TAM) classification scheme and TAM ranging from 185° (minimum) to 258° (maximum) across zones V-VIII.  Dynamic splinting studies demonstrated a percentage of "excellent/good" results ranging from 81 % (minimum) and 100 % (maximum) and TAM ranging from 214° (minimum) and 261° (maximum).  Early active splinting studies showed "excellent/good" results ranging from 81 % (minimum) and 100 % (maximum).  Only 1 study evaluated TAM in zones V-VIII, which ranged from 160° (minimum) and 165° (maximum) when using 2 different early active modalities.  The authors concluded that the available level 3 evidence suggested better outcomes when using dynamic splinting over static splinting.  Moreover, they stated that additional studies comparing dynamic and early active motion protocols are needed before a conclusive recommendation can be made.

Trismus refers to the spastic contraction of the muscles of mastication, which can lead to mandibular hypomobility.  Mandibular hypomobility is a condition in which the patient lacks normal ROM in the temporomandibular joint (TMJ).  Patients suffering from this condition are unable to separate the maxilla and mandible without pain, or simply are unable to open the mouth to the extent of functional disability.  They are unable to chew or eat normally or without pain, and may be unable to speak normally or maintain proper oral hygiene.  Severe jaw hypomobility can lead to malnutrition, infection, and serious disability.  

The Dynasplint Trismus System is designed to aid in restoring physical function in patients suffering from joint or muscle stiffness and limited range ROM in the posterior mandibular or TMJ region.  These functional limitations can be caused by a variety of conditions, such as: TMJ dysfunction, head and neck cancers, head and neck surgery, radiation therapy, fractures, trauma, infection, burns, congenital/developmental conditions, osteoarthritis, scleroderma, and others.

Stubblefield et al (2010) conducted a retrospective cohort study examining the effectiveness of a dynamic jaw opening device (Dynasplint Trismus System [DTS]) as part of a multi-modal treatment strategy for trismus in 20 patients with head and neck cancer.  All patients underwent assessment by a board-certified physiatrist and were referred to physical therapy for delivery of the DTS and instructed to progress use of the DTS to 30 minutes 3 times a day.  Additional modalities for the treatment of trismus including pain medications and botulinum toxin injections were prescribed as clinically indicated.  Change in maximal interincisal distance (MID) as documented in the medical record.  The use of the DTS as part of multi-modal therapy including physical therapy, pain medications, and botulinum toxin injections as deemed clinically appropriate resulted in an overall improvement of the MID from 16.5 mm to 23.5 mm (p < 0.001).  Patients who could comply with the treatment recommendations for DTS treatment did better than those who could not, with an improvement of the MID from 16 mm to 27 mm (p < 0.001) versus 17 mm to 22 mm (p = 0.88).

In a retrospective clinical trial, Schulman and colleagues (2008) evaluated the effect of the DTS (Dynasplint Systems Inc, Severna Park, MD) for patients recently diagnosed with trismus following radiation therapy, dental treatment, oral surgery, or following a neural pathology such as a stroke.  The histories of 48 patient (treated in 2006 to 2007) were reviewed, and divided into 4 cohort groups (radiation therapy for head/neck cancer, dental treatment, oral surgery, or stroke), to measure the efficacy of this treatment's modality.  Patients were prescribed the DTS after diagnosis of trismus based on examination that showed less than 40 mm MID.  The DTS uses low-load, prolonged-duration stretch with replicable, dynamic tension to achieve longer time at end ROM.  Each patient used this device for 20 to 30 mins, 3 times per day.  In this cohort case series the results showed that there was a statistically significant difference within all patient groups (p < 0.0001; t = 10.3289), but there was not a significant difference between groups (p = 0.374).  The biomechanical modality of DTS with a low-load, prolonged-duration stretch was attributed to the success in reducing contracture in this study.  This improved ROM allowed patients to regain the eating, hygiene and speaking patterns they had before developing trismus.

Guidelines from the International Society for Oral Oncology (2011) state that "[n]o guideline [is] possible regarding use of Dynasplint^® Trismus System in the reduction of RT-induced trismus, although may have some benefit for reduction of contracture of the muscles of mastication (Level of evidence III, Recommendation grade B)."

Furia et al (2013) evaluated the safety and effectiveness of dynamic splinting as it is used to treat joint contracture in lower extremities, and determined if duration on total hours of stretching had an effect on outcomes.  Reviews of PubMed, Science Direct, Medline, AMED, and EMBASE websites were conducted to identify the term 'contracture reduction' in manuscripts published from January 2002 to January 2012.  Publications selected for inclusion were controlled trials, cohort studies, or case series studies employing prolonged, passive stretching for lower extremity contracture reduction.  A total of 354 abstracts were screened and 8 studies (487 subjects) met the inclusion criteria.  The primary outcome measure was change in active ROM (AROM).  The mean aggregate change in AROM was 23.5° in the 8 studies examined.  Dynamic splinting with prolonged, passive stretching as home therapy treatment showed a significant direct, linear correlation between the total number of hours in stretching and restored AROM.  No adverse events were reported.  The authors concluded that dynamic splinting is a safe and effective treatment for lower extremity joint contractures.  Joint specific stretching protocols accomplished greater durations of end-range stretching that may be considered to be responsible for connective tissue elongation.

Veltman et al (2015) performed a comprehensive review of the literature to evaluate the best current evidence for non-operative treatment options for post-traumatic elbow stiffness.  These investigators performed a search of all studies on non-operative treatment for elbow stiffness in human adults.  All articles describing non-operative treatment of elbow stiffness, written in the English, German, French or Dutch language, including human adult patients and with the functional outcome reported were included in this study.  A total of 8 studies (including 232 patients) met the eligibility criteria and were included for data analysis and pooling.  These studies included 1 RCT and 7 retrospective cohort studies.  Static progressive splinting was evaluated in 160 patients.  The average pre-splinting ROM of all elbows was 72°, which improved by 36° after splinting to an average post-splinting arc of motion of 108°.  Dynamic splinting was evaluated in 72 patients with an average pre-splinting ROM of 63°.  The average improvement was 37° to an average post-splinting arc of motion of 100°.  The authors concluded that both dynamic orthoses and static progressive splinting showed good results for the treatment of elbow stiffness, regardless of etiology.  The choice for one treatment over the other is based on the preference of the surgeon and patient.  These investigators recommended continuing non-operative treatment with dynamic or static bracing for 12 months or until patients stop making progression in ROM of the elbow.

Dynamic Splinting to Improve Outcomes following Botulinum Toxin Injection for Treatment of Limb Spasticity

Mills and colleagues (2016) examined the quality of evidence from RCTs on the effectiveness of adjunct therapies following botulinum toxin (BTX) injections for limb spasticity. MEDLINE, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials electronic databases were searched for English language human studies from 1980 to May 21, 2015.  Randomized controlled trials evaluating adjunct therapies post-BTX injection for treatment of spasticity were included.  Of the 268 studies screened, 17 met selection criteria.  Two reviewers independently assessed risk of bias using the Physiotherapy Evidence Database (PEDro) scale and graded according to Sackett's levels of evidence.  A total of 10 adjunct therapies were identified.  Evidence suggested that adjunctive use of ES, modified constraint-induced movement therapy, physiotherapy (all Level 1), casting and dynamic splinting (both Level 2) result in improved Modified Ashworth Scale scores by at least 1 grade.  There is Level 1 and 2 evidence that adjunctive taping, segmental muscle vibration, cyclic functional ES, and motorized arm ergometer may not improve outcomes compared with BTX injections alone.  There is Level 1 evidence that casting is better than taping, taping is better than ES and stretching, and extra-corporeal shock wave therapy is better than ES for outcomes including the Modified Ashworth Scale, ROM and gait.  All results are based on single studies.  The authors concluded that there is high level evidence to suggest that adjunctive therapies may improve outcomes following BTX injection.  Moreover, they stated that no results have been confirmed by independent replication; all interventions would benefit from further study.

Dynamic Spinting for Hallux Valgus

Plaass and colleagues (2020) noted that vallux valgus is a common diagnosis in orthopedics.  Only a few studies have analyzed the effects of conservative therapy.  These investigators analyzed the effect of a dynamic hallux valgus splint.  A total of 70 patients were included in this prospective, randomized trial.  Patients with a hallux valgus were treated using a dynamic splint or underwent no treatment.  Clinical and radiological parameters were evaluated.  These researchers found no significant changes in hallux valgus angle, inter-metatarsal I-II angle, the American Orthopedic Foot and Ankle Society (AOFAS) score, foot and ankle outcome score (FAOS), or the 36-Item Short Form Health Survey (SF-36) score between the groups.  However, a significant between-group difference was found for pain during walking and running and in the FAOS sub-scale for pain and pain at rest at follow-up.  The authors concluded that wearing a dynamic hallux valgus splint provided some pain relief in patients with a symptomatic hallux valgus, but showed no effect on hallux valgus position.

An UpToDate review on “Hallux valgus deformity (bunion)” (Ferrari, 2019 ) states that “Studies of splinting for hallux valgus are limited by their small sample sizes and risk of bias.  Night splints were ineffective in reducing pain associated with HV deformity in one small randomized trial.  Progression of the deformity did not occur in the treatment or the control group over the 6-month trial duration.  Night splints were more effective in reducing deformity and pain than a toe separator, but they were less effective than exercises, in another small study.  However, the mean decrease in HA angle was approximately 2 degrees, which was within the range of measurement error.  A study of 30 patients comparing night splints to a toe separator attached to a semi-rigid insole reported a significant reduction in pain intensity at 3 months in the group using the toe separator insole, but changes in HA and IMA angles were not significantly different and the decrease in pain in the insole group may be attributable to the change in footwear.  A study of 30 subjects compared night splints to a slipper containing a toe separator reported improvement in the HV angle in the slipper group after 1 year but is the changes were not clinically meaningful.  A study of 20 female subjects comparing taping and exercises versus exercise alone reported statistically significant short-term reductions in pain and improved walking in the taping group.  This study also reported improvements for both groups in HV and IM angles, but the changes were small and within the margin of error”.  Moreover, this review does not mention dynamic splinting as a therapeutic option.

Flexionators and Extensionators

The shoulder flexionator (ERMI Shoulder Flexionater) is designed to isolate and treat decreased glenohumeral abduction and external rotation.  The device is intended to addresses the needs of patients with excessive scar tissue.  This customizable device has biomechanically and anatomically located pads to focus treatment on the glenohumeral joint, without stressing the other shoulder joints.  Once customized, the shoulder flexionator can be used by the patient at home without assistance to perform serial stretching exercises, alternately stretching and relaxing the scar tissue surrounding the glenohumeral joint.  The device has 3 sections, the main frame, arm unit and pump unit.  The shoulder flexionator was listed with the FDA in 2001, and is Class I exempt.

The knee/ankle flexionator (ERMI Knee/Ankle Flexionater) is a self-contained device that facilitates recovery from decreased range of motion of the knee and/or ankle joints.  The knee flexionator is designed to address the needs of patients with arthrofibrosis (excessive scar tissue within and around a joint).  The knee/ankle flexionator is a variable load/variable position device that uses a hydraulic pump and quick-release mechanism to allow patients to perform dynamic stretching exercises in the home without assistance, alternately stretching and relaxing the scar tissue surrounding affected joints.  The knee/ankle flexionator includes a frame to house hydraulic components, a pump handle and quick release valve for patient control, supporting footplate and specially incorporated padded chair.  The frame attaches to a folding chair and is adjustable to accommodate treatment of either extremity, or both extremities simultaneously.  The load potential ranges from a few ounces up to 500 foot-pounds.  The knee/ankle flexionator was listed with the FDA in 2002, and is Class 1 exempt.

The knee extensionator (ERMI Knee Extensionater) and elbow extensionator (ERMI Shoulder Extensionater) provide serial stretching, using a patient-controlled pneumatic device that can deliver variable loads to the affected joint.  The manufacturer claims that the knee and shoulder extensionators are the only devices on the market that can “consistently stretch scar tissue, without causing vascular re-injury and thereby significantly reduce the need for additional surgery” (ERMI, 2002).  The extensionator telescopes to the appropriate length, and is applied to the leg with Velcro straps.  During a typical training session, the joint is stretched from 1 to 5 mins, and then is allowed to recover for an equal length of time, and is then stretched again.  A typical training session lasts 15 mins, and the usual prescription is to perform 4 to 8 training sessions per day.  There are no controlled published peer-reviewed studies on the effectiveness of the knee/ankle flexionator, the shoulder flexionator, the knee extensionator, or the elbow extensionator.  There is insufficient scientific evidence to support the manufacturer's claims that these home-based stretching devices can consistently stretch scar tissues without causing vascular re-injury and thus significantly reduce the need for additional surgery (e.g., surgery for arthrofibrosis after knee surgery).  Furthermore, there is a lack of published data to support the claim that these devices can reduce the need for surgery manipulation under anesthesia.  Therefore, extensionator and flexionator devices are considered experimental and investigational.

The Elite Seat is a portable knee hyper-extension rehabilitation device that is used to correct the loss of knee extension, increase ROM, decrease knee pain and improve function.  However, there is insufficient evidence to support the use of the Elite Seat.

Joint Active Systems (JAS) Splints

JAS splints (e.g., JAS Elbow, JAS Shoulder, JAS Ankle, JAS Knee, JAS Wrist, and JAS Pronation-Supination) (Joint Active Systems, Effingham, IL) use static progressive stretch.  According to the manufacturer's website, "Static Progressive Stretch (SPS) and dynamic splinting are two fundamentally different techniques used to permanently lengthen shortened connective tissues."  Typically, the patient sets the device angle at the beginning of the session, and every several mins the angle is increased.  A typical session lasts 30 mins, and sessions may be repeated up to 3 times per day.  Unlike the flexionator, the joint is not allowed to recover during the stretch period.  According to the manufacturer, JAS systems are designed to simulate manual therapy.  The manufacturer claims that JAS devices eliminate the risk of joint compression, provide soft tissue distraction, and “achieve permanent soft tissue lengthening in a short amount of time.”  Published reports of the effectiveness of JAS splints are limited to case reports and small uncontrolled observational studies.  There are no prospective randomized studies demonstrating that the addition of the use of JAS devices to the physical therapy management of patients with joint injury or surgery significantly improves patient's clinical outcomes.  Thus, JAS splints are considered experimental and investigational.

EZ Turnbuckle Orthosis (Joint Active Systems Orthosis)

Green and McCoy (1979) reported the findings of 15 patients with acute flexion contractures of the elbow after injuries or operations were treated with a turnbuckle splint. Satisfactory correction was achieved in 12 patients.  An average reduction in deformity of about 37 degrees was recorded after an average treatment period of 20 weeks.  The treatment was unsuccessful in 3 patients with severe intra-articular damage because the splint caused excessive discomfort.  The average improvement in the arc of motion of the elbow was approximately 43 degrees.  This was a small study (n = 15); its findings need to be validated in well-designed studies.

Gelinas et al (2000) treated 22 patients with an elbow contracture using a static progressive turnbuckle splint for a mean of 4.5 +/- 1.8 months. All had failed to improve with supervised physiotherapy and splinting.  The mean range of flexion before splintage was from 32 +/- 10 degrees to 108 +/- 19 degrees and afterwards from 26 + 10 (p = 0.02) to 127 +/- 12 degrees (p = 0.0001).  A total of 11 patients gained a “functional arc of movement”, defined as at least 30 degrees to 130 degrees.  In 8 patients movement improved with turnbuckle splinting, but the functional arc was not achieved; 6 of these were satisfied and did not wish to proceed with surgical treatment and 2 had release of the elbow contracture.  In 3 patients, movement did not improve with the use of the turnbuckle splint and 1 subsequently had surgical treatment.  The authors concluded that these findings showed that turnbuckle splinting is a safe and effective treatment that should be considered in patients whose established elbow contractures have failed to respond to conventional physiotherapy.  This was a small study (n = 22); its findings need to be validated in well-designed studies.

Bhat et al (2010) evaluated the effectiveness of a turnbuckle orthosis as a means of improving the range of motion (ROM) in patients with elbow stiffness. A total of 17 males and 11 females aged 8 to 68 (mean of 32) years underwent static progressive stretching using a turnbuckle orthosis for elbow stiffness secondary to trauma or surgery.  Patients were instructed to wear the orthosis during the daytime for a mean of 15 hours and remove it during sleep as well as at breakfast, lunch, and dinner.  One hour of ROM exercise was performed during each break.  Patients were followed-up every month and ROM was recorded with a standard goniometer.  The use of orthosis was discontinued when there was no further improvement; ROM exercise was encouraged thereafter to maintain the results.  The extent of flexion contracture and ROM before and after the treatment were compared.  The mean duration of orthosis use was 5 (range of 3 to 8) months.  The mean flexion contracture reduced from 59 degrees to 27 degrees and ROM improved from 57 degrees to 102 degrees; 19 of the patients achieved functional ROM.  Improvement in ROM was excellent in 6 patients, good in 11, satisfactory in 7; at the end of follow-up (mean of 29 months), the results were maintained or improved further in 20 patients (even in those with long-standing contractures).  The authors concluded that static progressive stretching using a turnbuckle orthosis is reliable and cost-effective for treating elbow stiffness.  Again, this was a small study (n = 28); its findings need to be validated in well-designed studies.

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:
29126	Application of short arm splint (forearm to hand); dynamic [not covered for carpal tunnel syndrome]
29131	Application of finger splint; dynamic
29505	Application of long leg splint (thigh to ankle or toes)
29515	Application of short leg splint (calf to foot)
Other CPT codes related to the CPB:
25515	Open treatment of radial shaft fracture, includes internal fixation, when performed
29105	Application of long arm splint (shoulder to hand)
97760	Orthotic(s) management and training (including assessment and fitting when not otherwise reported), upper extremity(s), lower extremity(s) and/or trunk, each 15 minutes
HCPCS codes covered if selection criteria are met:
Advance Dynamic ROM, Pro-glide dynamic ROM, SaeboReach, EZ Turnbuckle Orthosis-No specific code:
E1800	Dynamic adjustable elbow extension/flexion device, includes soft interface material
E1802	Dynamic adjustable forearm pronation/supination device, includes soft interface material [not covered for carpal tunnel syndrome]
E1805	Dynamic adjustable wrist extension/flexion device, includes soft interface material [not covered for carpal tunnel syndrome]
E1810	Dynamic adjustable knee extension/flexion device, includes soft interface material
E1815	Dynamic adjustable ankle extension/flexion device, includes soft interface material
E1825	Dynamic adjustable finger extension/flexion device, includes soft interface material
E1830	Dynamic adjustable toe extension/flexion device, includes soft interface material
E1831	Static progressive stretch toe device, extension and/or flexion, with or without range of motion adjustment, includes all components and accessories
HCPCS codes not covered for indications listed in the CPB:
ERMI Knee/Ankle Flexionator, MPJ Extensionator, ERMI Elbow Extensionator , ERMI Shoulder Flexionator, ERMI Knee Extensionator, SaeboMas, JAZ EZ,Medi-Dyne Prostretch - No specific code :
E1801	Static progressive stretch elbow device, extension and/or flexion, woth or without range of motion adjustment, includes all components and accessories
E1806	Static progressive stretch wrist device, flexion and/or extension, with or without range of motion adjustment, includes all components and accessories
E1811	Static progressive stretch knee device, extension and/or flexion, with or without range of motion adjustment, includes all components and accessories
E1816	Static progressive stretch ankle device, flexion and/or extension, with or without range of motion adjustment, includes all components and accessories
E1818	Static progressive stretch forearm pronation/supination device, with or without range of motion adjustment, includes all components and accessories
E1821	Replacement soft interface material/cuffs for bi-directional static progressive stretch device
E1840	Dynamic adjustable shoulder flexion/abduction/rotation device, includes soft interface material
E1841	Static progressive stretch shoulder device, with or without range of motion adjustment, includes all components and accessories
L3100	Hallus-valgus night dynamic splint, prefabricated, off-the-shelf
Other HCPCS codes related to the CPB:
J0585	Injection, onabotulinumtoxinA, 1 unit
J0586	Injection, abobotulinumtoxinA, 5 units
J0587	Injection, rimabotulinumtoxinB, 100 units
J0588	Injection, incobotulinumtoxinA, 1 unit
ICD-10 codes covered if selection criteria are met:
M24.571 - M24.576	Contracture, ankle and foot
ICD-10 codes not covered for indications listed in the CPB:
G35	Multiple sclerosis
G56.00 - G56.03	Carpal tunnel syndrome
G71.00 - G72.9, G73.7	Primary disorders of muscles and other and unspecified myopathies
G80.0 - G80.9	Cerebral palsy
G97.31 - G97.32	Intraoperative hemorrhage and hematoma of a nervous system organ or structure complicating a procedure
I63.00 - I66.9	Occlusion and stenosis of precerebral and cerebral arteries [stroke]
I97.810 - I97.821	Intraoperative and postprocedural cerebrovascular infarction
M05.00 - M05.09, M05.20 - M06.39, M06.80 - M06.9, M08.00 - M08.09, M08.20 - M08.3, M08.40 - M08.99	Rheumatoid arthritis with rheumatoid factor, other rheumatoid arthritis and juvenile arthritis
M20.10 - M20.12	Hallux valgus (acquired)
M21.371 - M21.379	Foot drop (acquired) [foot drop associated with neuromuscular diseases]
M72.2	Plantar fascial fibromatosis [plantar fascitits]
R25.2	Cramp and spasm [trismus]
S06.0x0+ - S06.9x9+	Intracranial injury
S09.90x+	Unspecified injury of head
S12.000+ - S12.9xx+, S14.010+ - S14.159+, S22.000+ - S22.089+, S24.101+ - S24.159+, S32.000+ - S32.2xx+, S34.101+ - S34.139+, S34.3xx+	Fracture of vertebral column with spinal cord injury
S52.121A - S52.126S	Fracture of head of radius

The above policy is based on the following references: