LEEDer Group Inc.
8508 North West 66th St.
Miami, Florida 33166 USA

Phone: 305.436.5030
Fax: 305.436.0086
E-mail Address: info {at] LEEDerGroup [dot] com

Dynamic Splints-Splinting

  • Clinical Policy Bulletins Number: 0405
    Subject: Mechanical Stretching Devices for Contracture and Joint Stiffness
  • Important Note
    This Clinical Policy Bulletin expresses Aetna’s determination of whether certain services or supplies are medically necessary. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Aetna expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member’s benefit plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Aetna) for a particular member. The member’s benefit plan determines coverage. Some plans exclude coverage for services or supplies that Aetna considers medically necessary. If there is a discrepancy between this policy and a member’s plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members.
  • Policy Dynamic Splinting Devices:
    Aetna considers dynamic splinting devices for the knee, elbow, wrist or finger medically necessary durable medical equipment (DME) if either of the following two selection criteria is met:
    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
    In the acute post-operative period for members who have a prior documented history of motion stiffness/loss in a joint and are having additional surgery or procedures done to improve motion to that joint.
  • Aetna considers the prophylactic use of dynamic splinting 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 not medically necessary. 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 in the management of joint injuries of the shoulder, ankle and toe experimental and investigational because there is a lack of scientific evidence regarding its effectiveness for these indications.
  • Flexionators and Extensionators:
    Aetna considers the knee/ankle flexionator, the shoulder flexionator, the knee extensionator, and the elbow extensionator experimental and investigational because of a lack of 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.
  • Background 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, 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, and EMPI Advance.
  • 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 three 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 minutes, and then is allowed to recover for an equal length of time, and is then stretched again. A typical training session lasts 15 minutes, 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.
  • 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. Typically, the patient sets the device angle at the beginning of the session, and every several minutes the angle is increased. A typical session lasts 30 minutes, and sessions may be repeated up to three 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 case series. 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.
  • The above policy is based on the following references:
    1. Halar EM, Bell KR. Contracture and other deleterious effects of immobility. In: Rehabilitation Medicine: Principles and Practice. 2nd ed. JA DeLisa, ed. , Philadelphia, PA: J.B. Lippincott Co.; 1993; Ch. 33, pp 681-699.
    2. McClure PW, Blackburn LG, Dusold C. The use of splints in the treatment of joint stiffness: Biologic rationale and an algorithm for making clinical decisions. Phys Ther. 1994;74(12):1101-1107.
    3. Hepburn GR, Crivelli KJ. Use of elbow Dynasplint for reduction of elbow flexion contractures: A case study. J Orthop Sports Phys Ther. 1984;5(5):269-274.
    4. Richard RL. Use of the Dynasplint to correct elbow flexion burn contracture: A case report. J Burn Care Rehabil. 1986;7(2):151-152.
    5. Mackay-Lyons M. Low-load, prolonged stretch in treatment of elbow flexion contractures secondary to head trauma: A case report. Phys Ther. 1989;69(4):292-296.
    6. Richard RL, Jones LM, Miller SF, Finley RK Jr. Treatment of exposed bilateral Achilles tendons with use of the Dynasplint. Phys Ther. 1988;68(6):989-991.
    7. Hepburn GR. Case studies: Contracture and stiff joint management with Dynasplint. J Orthop Sports Phys Ther. 1987;8:498-504.
    8. Steffen TM, Mollinger LA. Low-load, prolonged stretch in the treatment of knee flexion contractures in nursing home residents. Phys Ther. 1995;75(10):886-897.
    9. Chow JA, Thomes LJ, Dovelle S, et al. Controlled motion rehabilitation after flexor tendon repair and grafting. J Bone Joint Surg. 1988;70(4):591-595.
    10. Chow JA, Dovelle S, Thomes LJ, et al. A comparison of results of extensor tendon repair followed by early controlled mobilization versus static immobilization. J Hand Surg. 1989;14(1):18-20.
    11. Browne EZ Jr, Ribik CA. Early dynamic splinting for extensor tendon injuries. J Hand Surg [Am]. 1989;14(1):72-76.
    12. Kerr CD, Burczak JR. Dynamic traction after extensor tendon repair in zone 6, 7, and 8: A retrospective study. J Hand Surg [Br]. 1989;14(1):21-25.
    13. Saldana MJ, Chow JA, Gerbino P 2nd, et al. Further experience in rehabilitation of zone II flexor tendon repair with dynamic traction splinting. Plast Reconstr Surg. 1991;87(3):543-546.
    14. Hung LK, Chan A, Chang J, et al. Early controlled active mobilization with dynamic splintage for treatment of extensor tendon injuries. J Hand Surg [Am]. 1990;15 (2):251-257.
    15. Saldana MJ, Choban S, Westerbeck P, Schacherer TG. Results of acute zone III extensor tendon injuries treated with dynamic extension splinting. J Hand Surg [Am]. 1991;16 (6):1145-1150.
    16. Rives K, Gelberman R, Smith B, Carney K. Severe contractures of the proximal interphalangeal joint in Dupuytren’s disease: Results of a prospective trial of operative correction and dynamic extension splinting. J Hand Surg [Am]. 1992;17 (6):1153-1159.
    17. May EJ, Silfverskiold KL, Sollerman CJ. The correlation between controlled range of motion with dynamic traction and results after flexor tendon repair in zone II. J Hand Surg [Am]. 1992;17 (6):1133-1139.
    18. Blair WF, Steyers CM. Extensor tendon injuries. Orthop Clin North Am. 1992;23(1):141-148.
    19. Center for Medicare and Medicaid Services (CMS). Payment and coding determinations for new durable medical equipment. CMS Public Meeting Agenda. Baltimore, MD: CMS; June 17, 2002. Available at: http://www.hcfa.gov/medicare/jun2dme.pdf. Accessed July 25, 2002.
    20. ERMI, Inc. Insurance Provider Information Folder. Decatur, GA: ERMI; 2002.
    21. Bonutti PM, Windau JE, Ables BA, et al. Static progressive stretch to reestablish elbow range of motion. Clin Orthop. 1994;303:128-134.
    22. Jansen CM, Windau JE, Bonutti PM, et al. Treatment of a knee contracture using a knee orthosis incorporating stress-relaxation techniques. Phys Ther. 1996;76(2):182-186.
    23. Cohen EJ. Adjunctive therapy devices: Restoring ROM outside of the clinic. Phys Ther Magazine. 1995 Mar:10-13.
    24. Joint Active Systems, Inc. JAS OnLine [website]. Effingham, IL: Joint Active Systems; 2002. Available at: http://www.jointactivesystems.com. Accessed September 11, 2002.
    25. Branch TP, Karsch RE, Mills TJ, Palmer MT. Mechanical therapy for loss of knee flexion. Am J Orthop. 2003;32(4):195-200.
    26. Egan M, Brosseau L, Farmer M, et al. Splints and Orthosis for treating rheumatoid arthritis (Cochrane Review). In: The Cochrane Library, Issue 3, 2003. Oxford, UK: Update Software.
    27. Washington State Department of Labor and Industries, Office of the Medical Director. ERMI Flexionators and Extensionators. Health Technology Assessment Brief. Olympia, WA: Washington State Department of Labor and Industries; updated June 6, 2003. Available at: www.lni.wa.gov/ClaimsInsurance/Files/OMD/ermi.pdf. Accessed June 3, 2004

Property of Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 13, 2004