Mechanical Stretching Devices including Dynamic Splinting Devices

 

Medical Policy: 01.01.16 

Original Effective Date: March 2009 

Reviewed: January 2020 

Revised: January 2020 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Mechanical stretching devices are generally proposed as an adjunct treatment to PT and/or exercise. 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 physical therapy (PT) and/or exercise. Physical Therapy (PT)/Occupational Therapy (OT) procedures and stretching devices have been developed to increase ROM without damaging the affected joint or its related muscles, tendons, and connective tissue.

 

Several types of dynamic splinting devices are available:

 

Types of Devices

Low-Load Prolonged-Duration Stretch (LLPS) Devices/Dynamic Splinting Systems:

LLPS devices permit active and passive motion with elastic traction within a limited range. The devices maintain a set level of tension by incorporated springs. Examples of low-load, prolonged-duration stretch (LLPS) devices include:

  • Dynasplint System® (Dynasplint Systems, Inc., Severna Park, MD) 
  • Ultraflex (Ultraflex Systems, Pottstown, PA) 
  • Pro-glide™ Dynamic ROM devices (DeRoyal®, Powell, TN) 
  • Advance Dynamic ROM® devices (Empi, St. Paul, MN)

 

Static Progressive (SP) Stretch Devices:

SP stretch devices hold the joint in a set position, while allowing manual modification of the joint angle, and may allow active motion without resistance. The device does not exert stress on the tissue unless the angle is set to the joint’s limitation. This type of device allows a limited range of passive or active motion, but the motion is free and does not provide elastic traction. Available static progressive (SP) stretch devices include:

  • Joint Active Systems (JAS) Static Progressive Stretch devices (finger, wrist, elbow, shoulder, knee, ankle) (Joint Active Systems, Inc., Effington, IL)
  • JAS Pronation/Supination device
  • Static-Pro® Knee (DeRoyal Industries, Inc.)

 

Patient-Actuated Serial Stretch (PASS) Devices:

PASS devices provide a low-to high-level load to the joint using pneumatic (Extensionators [ERMI} or hydraulic (Flexionators [ERMI}) systems that are adjusted by the patient. PASS devices are custom-fitted and are available for the ankle, elbow, knee, and shoulder. A customized treatment protocol and training in use of the device are provided to the patient. Available patient-actuated serial stretch (PASS) devices include:

  • ERMI Knee Extensionator®, ERMI Knee/Ankle Flexionator®, ERMI Shoulder Flexionator®, ERMI MPJ Extensionator®, ERMI Elbow Extensionator® II (ERMI, Inc., Atlanta, GA)

 

Jaw Stretch Devices:

Jaw stretch devices are devices that open the jaw to stretch the oro-facial tissues and mobilize the temporomandibular joint (TMJ). It is used primarily to prevent and treat trismus and scarring or fibrosis from radiation therapy, surgery, and trauma. Brands include:

  • TheraBite® Jaw Motion Rehabilitation System™
  • OraStretch™ Press Jaw Motion Rehab

 

Limb Support System

  • SaeboStretch® (Saebo, Charlotte, NC)

 

The use of low-load prolonged stretch (LLPS) splinting devices are proven for improvement of range of motion after surgery or injury when physical therapy alone has not been effective. The use is limited to joints of the knee, elbow, toe, finger, and wrist. Use in other joints has not been proven at this time. Use prophylactically has not been proven at this time. Success in use with chronic or long-term fixed contractures has not been proven at this time.

 

Prior Approval:

Not applicable

 

Policy:

Low-Load Prolonged Stretch (LLPS)/Dynamic Splinting Devices

Low-load prolonged stretch (LLPS) will be considered medically necessary for those with contractures of the following joints, caused by injury or joint stiffness of the following joints:

  • Knee
  • Elbow
  • Toe - only for persistent stiffness of hallux limitus following bunionectomy or cheilectomy
  • Finger
  • Wrist

 

Criteria

  • Only after a trial of physical therapy has been ineffective in improving range of motion.
  • The use can also be as an adjunct to physical therapy, but only after physical therapy alone has been ineffective in improving range of motion use will this be considered medically necessary.
  • The use of LLPS/dynamic splinting devices is limited to four months of use

 

There is no evidence that prolonged use of dynamic splinting devices past four months has been any more effective in long-term outcomes.

 

Dynamic splinting devices (dynamic (low-load prolonged stretch [LLPS]) devices are considered investigational for use with joints other than knee, elbow, toe, finger, and wrist.

 

Dynamic splinting devices (dynamic (low-load prolonged stretch [LLPS]) devices which are specific to the ankle and shoulder are considered investigational for all indications including but not limited to the management of chronic joint stiffness or chronic fixed contractures due to trauma, fractures, burns, head and spinal cord injury, rheumatoid arthritis, multiple sclerosis, muscular dystrophy, or cerebral palsy. Based on peer reviewed literature there is lack of scientific evidence regarding the safety and effectiveness of dynamic splinting for these indications.

 

The use of dynamic splinting devices are not appropriate and are unproven in the pediatric population. Dynamic splinting devices are investigational for pediatrics, those patients under 18 years of age.

 

The use of dynamic splinting devices are not appropriate and unproven in the use of chronic conditions including, but not limited to: contractures from chronic conditions, arthritis. Prophylactic use of dynamic splinting is investigational in the management of chronic contractures.

 

Dynamic splinting is considered investigational for the following indications (this is not an all-inclusive list):

  • Carpal tunnel syndrome
  • Cerebral palsy and congenital quadriplegia
  • Epilepsy
  • Foot drop associated with neuromuscular diseases
  • Head and spinal cord injuries
  • Multiple sclerosis
  • Muscular dystrophy
  • Plantar Fasciitis
  • Rheumatoid arthritis
  • Stroke
  • Trismus
  • Bunion
  • Halux valgus or halux rigidus
  • Injuries of ankle
  • Injuries of the shoulder
  • Burns
  • Temporomandibular Joint Disease (TMJ)
  • Chronic contractures

 

Based on peer reviewed literature there is lack of scientific evidence regarding the safety and effectiveness of dynamic splinting for these indications and therefore, is considered investigational.

 

Joint Active Systems (JAS) Splints/Bi-Directional Static Progressive Stretch (SPS)/Static Progressive (SP) Stretch Devices:

Bi-directional static progressive stretch (SPS) devices including JAS splints (e.g., JAS Elbow, JAS Shoulder, JAS Ankle, JAS Knee, JAS Wrist, and JAS Pronation-Supination) are considered investigational for all indications.

 

Clinical evidence is not sufficient to demonstrate that use of static progressive or patient actuated devices is a safe or effective treatment option. Studies are limited to small sample sizes. Based on peer review literature clinical evidence is not sufficient to demonstrate that the use of a static progressive stretch device improves long-term patient outcomes. Evidence is limited to primarily short-term outcomes and lack of comparison to other treatment modalities and therefore is considered investigational for all indications.

 

Patient-actuated Serial Stretch (PASS) Devices

Patient-actuated serial stretch (PASS) (including but not limited to ERMI Flexonaters and Extensonators) devices are considered investigational for all indications.

 

Based on peer reviewed literature, there is lack of published studies investigating PASS devices, no conclusion can be drawn regarding their efficacy. Therefore, patient-actuated serial stretch (PASS) devices are considered investigational for all indications.

 

Jaw Stretch Devices

Use of jaw stretch devices (e.g. TheraBite, OraStretch) is considered investigational

Based on peer reviewed literature, there is lack of published studies investigating jaw stretch devices. No conclusion can be drawn regarding their efficacy.

 

SaeboMas Support System

Use of the SaeboMas support system is considered investigational.

 

Based on peer reviewed literature, there is lack of published studies investigating the SaeboMas support system for patients. No conclusion can be drawn regarding the efficacy.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • E1700 Jaw motion rehabilitation system
  • E1701 Replacement cushions for jaw motion rehabilitation system, package of 6
  • E1702 Replacement measuring scales for jaw motion rehabilitation system, package of 200
  • E1800 Dynamic adjustable elbow extension/flexion device includes soft interface material
  • E1801 Static progressive stretch elbow device, extension and/or flexion, with or without range of motion adjustment, includes all components and accessories
  • E1802 Dynamic adjustable forearm pronation/supination device, includes soft interface material
  • E1805 Dynamic adjustable wrist extension/flexion device,includes soft interface material
  • E1806 Static progressive stretch wrist device, flexion and/or extension, with or without range of motion adjustment, includes all components and accessories
  • E1810 Dynamic adjustable knee extension/flexion device, includes soft interface material
  • E1811 Static progressive stretch knee device, extension and/or flexion, with or without range of motion adjustment, includes all components and accessories
  • E1812 Dynamic knee, extension/flexion device with active resistance control
  • E1815 Dynamic adjustable ankle extension/flexion device, includes soft interface material
  • 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
  • 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
  • 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
  • E1399 Durable medical equipment, miscellaneous (Patient actuated serial stretch (PASS) device)

 

Selected References:

  • 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):1201-1107.
  • Harvey L, Herbert R, Crosbie J. Does stretching induce lasting increases in joint ROM? A systematic review. Physiother Res Int. 2002;7(1):1-13.
  • Branch TP, Karsch RE, Mills TJ, Palmer MT. Mechanical therapy for loss of knee flexion. Am J Orthop. 2003;32(4):195-200.
  • Doornberg JN, Ring D, Jupiter JB. Static progressive splinting for posttraumatic elbow stiffness. J Orthop Trauma. 2006 July;20(6):400-4.
  • ECRI. Mechancial Stretching Devices (ERMI Flexionaters and Extensionaters) for Contracture and Joint Stiffness. Plymouth Meeting (PA): ECRI Health Technology Information Service 2007 March 27. 5 p. (ECRI Hotline Response).
  • Bonutti PM, McGrath MS, Ulrich SD, McKenzie SA, Seyler TM, Mont MA. Static progressive stretch for the treatment of knee stiffness. Knee. 2008 Aug; 15(4):272-6.
  • ECRI. Joint Active Systems (JAS) Devices for Improving Range of Motion in Injured Joints. Plymouth Meeting (PA): ECRI Health Technology Information Service 2007 October 12. (ECRI Hotline Response).
  • ECRI. Mechanical Stretching Devices (ERMI Flexionaters and Extensionaters) for Contracture and Joint Stiffness. Plymouth Meeting (PA): ECRI Health Technology Information Service 2011 March 22. (ECRI Hotline Response).
  • Glasgow C, Tooth LR, Fleming J, Peters S. Dynamic splinting for the stiff hand after trauma: predictors of contracture resolution J Hand Ther. 2011 Jul-Sep;24(3):195-205.
  • John MM, Kalish S, Perns SV, Willis FB. Dynamic splinting for postoperative hallux limitus: a randomized, controlled trial. J Am Podiatr Med Assoc. 2011 Jul-Aug;101(4):285-8.
  • Glasgow C, Fleming J, Tooth LR, & Hockey RL. The long-term relationship between duration of treatment and contracture resolution using dynamic orthotic devices for the stiff proximal interphalangeal joint: A prospective cohort study J Hand Ther. 2012 Jan;25(1):38-47.
  • Ibraham M., Donatelli R., Hellman M., Echternach J. Efficacy of a Static Progressive Stretch Device as an Adjunct to Physical Therapy in Treating Adhesive Capsulitis of the Shoulder: A prospective, Randomized Study
  • Mahmoud I Ibrahim, Aaron J. Johnson et. al Treatment of Adhesive Capsulitis of the Shoulder with a Static Progressive Stretch Device: A Prospective Randmized Study. JLTMI; April 2013; Vol2294) 281-291.
  • Aaron J. Johnson, Shelton A McKensi et. al Assessment of Static Progressive Stretch for Treatment of Shoulder Stiffness. A Prospective Case Series. JLTMI; April2013;Vol22(4) 293-303.
  • Anneluuk Lindenhovius, M.D., PhD, Job Doornberg M.D.,PhD et. al A Prospective Randomized Controlled Trial of Dynamic Versus Static Progressive Elbow Splinting for Post-Traumatic Elbow Stiffness. J Bone Joint Surg Am: April 2012;Vol 94-A (8) 694-700.
  • Dempsey AL, Branch TP, Mills T, et al. High-intensity mechanical therapy for loss of knee extension for worker's compensation and non-compensation patients. Sports Med Arthrosc Rehabil Ther Technol. 2010;2:26. PMID 20939921
  • Lucado AM, Li Z, Russell GB, et al. Changes in impairment and function after static progressive splinting for stiffness after distal radius fracture. J Hand Ther. Oct-Dec 2008;21(4):319-325. PMID 19006757
  • Veltman ES, Doornberg JN, Eygendaal D, et al. Static progressive versus dynamic splinting for posttraumatic elbow stiffness: A systematic review of 232 patients. Arch Orthop Trauma Surg. 2015 Mar 13
  • Ultraflex® Systems, Inc.. Patient inspired solutions. [Ultrafex® Systems, Inc. Web site]. 2010.
  • Harvey LA, Katalinic OM, Herbert RD, Moseley AM, Lannin NA, et al. Stretch for the treatment and prevention of contractures. Cochrane Database Syst Rev. 2017 Jan 9;1:CD007455
  • Zatarain LA, Smith DK, Deng J, Gilbert J, Dietrich MS, et al. A Randomized Feasibility Trial to Evaluate Use of the Jaw Dynasplint to Prevent Trismus in Patients With Head and Neck Cancer Receiving Primary or Adjuvant Radiation-Based Therapy. Integr Cancer Ther. 2018 Sep;17(3):960-967

 

Policy History:

  • January 2020 - Annual Review, Policy Revised
  • January 2019 - Annual Review, Policy Revised
  • January 2018 - Annual Review, Policy Revised
  • January 2017- Annual Review, Policy Revised
  • January 2016 - Annual Review, Policy Revised
  • January 2015 - Annual Review, Policy Revised
  • February 2014 - Annual Review, Policy Revised
  • February 2013  - Annual Review, Policy Revised
  • February 2012 - Annual Review, Policy Revised
  • October 2011 - Annual Review, Policy Renewed
  • August 2010 - Annual Review, Policy Renewed

 

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark 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 Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.