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 Dynasplint, EMPI Advance, LMB Pro-glide, SaeboFlex, SaeboReach, 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
• Head and spinal cord injuries
• Injuries of the ankle, and shoulder 
• Multiple sclerosis
• Muscular dystrophy
• Plantar fasciitis
• Rheumatoid arthritis
• Stroke
• Trismus

Flexionators and Extensionators:

Aetna considers the knee/ankle flexionator, the shoulder flexionator, the knee extensionator,  knee extension devices (e.g. the Elite Seat), and the elbow extensionator 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 Ankle, 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.

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 range of motion (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 of motion (ROM) in the posterior mandibular or temporomandibular joint (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.

In 2010, Stubblefield et al conducted a retrospective cohort study examining the effectiveness of a dynamic jaw opening device (dynasplint trismus system [DTS]) as part of a multimodal 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 multimodal therapy including physical therapy, pain medications, and botulinum toxin injections as deemed clinically appropriate resulted in an overall improvement of the MID from 16.5mm to 23.5mm (P<.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<.001) versus 17 mm to 22 mm (P=.88).

Schulman and colleagues, 2008, in a retrospective clinical trial, evaluated the effect of the Dynasplint Trismus System (DTS; Dynasplint Systems Inc, Severna Park, Md, USA) 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--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 < 40 mm maximal interincisal distance. The DTS uses low-load, prolonged-duration stretch with replicable, dynamic tension to achieve longer time at end range (of motion). Each patient used this device for 20-30 min, 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 range of motion, allowing patients to regain the eating, hygiene and speaking patterns they had before developing trismus.

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.