Clinical UM Guideline

This document addresses dynamic low-load prolonged-duration stretch (LLPS) devices for the treatment of joint stiffness and contracture.

Dynamic LLPS (dynamic splinting) devices are designed to provide a low load, prolonged stretch to joints that have reduced range of motion secondary to immobilization, surgery, contracture, fracture, dislocation, or a number of additional non-traumatic disorders. The objective of stretch therapy is to improve range of motion without compromising the stability and quality of the connective tissue and joint.

Note: For additional information, please see the following documents:

• CG-DME-05 Cervical Traction Devices for Home Use
• DME.00038 Static Progressive Stretch (SPS) and Patient-Actuated Serial Stretch (PASS) Devices
• SURG.00008 Mechanized Spinal Distraction Therapy

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Medically Necessary:

Dynamic LLPS devices are considered medically necessary when criteria A, B and C below have been met:

1. For use in the following anatomical locations:
   1. Elbow; or
   2. Finger; or
   3. Knee; or
   4. Wrist;
      and
2. Clinical settings:
   1. During the subacute injury or post-operative period (greater than or equal to 3 weeks but less than or equal to 4 months after injury or operation); and
      1. As an addition to physical or occupational therapy in in individuals with signs and symptoms of persistent joint stiffness or contracture; or
      2. The individual’s limited range of motion poses a meaningful (as judged by the physician) functional limitation, AND who has not responded to other therapy (including physical or occupational therapy); or
   2. During the acute post-operative period for individuals who have undergone additional surgery to improve the range of motion of a previously affected joint; or
   3. For individuals unable to benefit from standard physical or occupational therapy modalities because of an inability to exercise;
      and
3. Duration:
   1. For an initial period of up to 4 months; or
   2. After 4 months: for as long as improvement can continue to be demonstrated.

Dynamic LLPS devices for the postoperative management of tendon repair, referred to as "protected motion", to limit motion and protect the underlying surgical repair are considered medically necessary. 

Replacement interface material used with the dynamic LLPS device is considered medically necessary when both the following criteria have been met:

1. The interface material is no longer functioning properly; and
2. The replacement material is requested for use during the time that the device is considered medically necessary.

Not Medically Necessary: 

If there is no significant improvement after 4 months of use, dynamic LLPS devices are considered not medically necessary under any circumstance, including but not limited to for individuals unable to benefit from standard physical or occupational therapy modalities because of an inability to exercise.

Dynamic LLPS devices are considered not medically necessary for use on any other joint or for any other condition not listed above, including but not limited to the management of chronic joint stiffness or chronic or fixed contractures.

This document describes clinical studies and expert recommendations, and explains whether dynamic low-load prolonged-duration stretch (LLPS) devices are clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Dynamic low-load prolonged stretch devices, also called dynamic LLPS devices, are braces that use springs to gently stretch a stiff joint over a long time. They are worn for several hours each day or overnight and can help improve how far a joint can move, also called range of motion. These devices are used after injury or surgery, or when a person has joint stiffness from conditions such as fractures, tendon repair, or neurologic disorders. They are most often used for the elbow, wrist, fingers, or knee. Studies suggest they may help improve movement and function, especially when used with therapy, but results can vary. Some people may not improve, and wearing the device for long periods can be uncomfortable. These devices are considered medically appropriate only in certain situations, such as during recovery after injury or surgery, and when other treatments have not worked. They are not recommended for long-term, fixed stiffness or for joints not listed above because studies have not shown clear benefit in those cases.

What the Studies Show

Studies have looked at how well these devices improve joint movement. One study in people with finger problems after surgery found that those who used dynamic LLPS devices as directed had greater improvement in joint movement than those who did not follow the program. This suggests that consistent use may help improve flexibility over time. Another study in people with contractures of the wrist, elbow and knee found that these devices improved range of motion and daily function. Both older adults with neurologic conditions and younger people with musculoskeletal problems showed benefit.

A study compared dynamic splints with dynamic LLPS devices for elbow stiffness after injury. Both groups improved over time, but there was no meaningful difference between the two methods. This suggests that improvement may come from stretching and exercise over time, not from one device type being better than another.

Some limits of the evidence include small study sizes and limited high-quality trials. Harms may include discomfort, skin irritation, or poor tolerance due to long wear times. These devices are widely used by orthopedists as well as occupational and physical therapists for selected populations. Feedback from clinicians in relevant specialties also supports the use of dynamic splinting in the clinical situations described in the Clinical Indications section of this document.

When is Dynamic LLPS Clinically Appropriate?

Dynamic LLPS devices may be appropriate in these situations:

• Use in the elbow, finger, knee, or wrist.
• During recovery after injury or surgery, between about 3 weeks and 4 months, and:
  • Used along with physical therapy or occupational therapy in people with ongoing joint stiffness or contracture, or
  • When limited motion causes meaningful problems with daily function and other treatments have not worked, or
• During early recovery after repeat surgery done to improve joint motion, or
• For individuals who cannot take part in standard therapy due to inability to exercise.

They may also be appropriate after tendon repair surgery to allow safe, limited movement while protecting the repair.

Use is typically limited to up to 4 months at first, and may continue longer only if there is clear ongoing improvement.

Replacement parts are appropriate if the device is still needed and the parts no longer work properly.

When is this not Clinically Appropriate?

Dynamic LLPS devices are not clinically appropriate in these situations:

• When there is no meaningful improvement after 4 months of use. Studies show that continued use without improvement does not provide added benefit.
• For joints other than the elbow, finger, knee, or wrist.
• For long-term stiffness or fixed contractures. Better studies are needed to know if these devices improve health in these cases.

Using these devices when they are not likely to help can lead to unnecessary discomfort, skin problems, and time spent on treatment that does not improve function.

Dynamic LLPS devices are not clinically appropriate in scenarios other than those listed above.

(Return to Description)

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.

When services are also Not Medically Necessary:
For the following procedure codes, or when the code describes a procedure or situation designated in the Clinical Indications section as not medically necessary.

Summary

Dynamic LLPS devices are spring-loaded, adjustable systems which provide a low-load prolonged stretch to joints. These devices are set at a fixed joint angle and worn over long periods (6-8 hours/day or overnight). Dynamic LLPS units provide extension as well as flexion and are available for various joints including the elbows, wrists, fingers, knees, ankles, and toes. These devices are being marketed for the treatment of joint stiffness due to immobilization or limited range of motion (ROM) as a result of various conditions, including, but not limited to, 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. The purpose of the dynamic LLPS device is to restore ROM to a joint without diminishing the stability and quality of the connective tissue and joint. Dynamic LLPS devices are frequently used during the post-operative period to prevent or treat stiffness or decreased ROM in the knee, elbow, wrist or finger. These devices are generally not used in other joints such as the hip, ankle or foot. Examples of this type of device include, but are not limited to:

• Dynasplint^® (Dynasplint Systems, Severna Park, MD); and
• JAS Dynamic (Joint Active Systems, Effingham, IL); and
• Pro-Glide™ (De Royal Industries, Powell, TN).

Discussion

Rives and colleagues (1992) reported the results of a prospective, non-randomized study in which a total of 23 proximal interphalangeal joints that were severely contracted (approximately 45 degrees) as a result of Dupuytren disease underwent operative correction and 6 months of dynamic extension splinting. Proximal interphalangeal joint extension was measured preoperatively and postoperatively at 3-month intervals for 1 year and at 6-month intervals thereafter. Mean follow-up was 2 years (minimum, 1 year). Overall, at 2 years, 44% improvement in proximal interphalangeal joint extension was noted. Mean improvement of 59% in proximal interphalangeal joint extension was noted in the participants who complied with the postoperative dynamic extension splinting program. Participants who were noncompliant demonstrated a 25% improvement in proximal interphalangeal joint extension. The difference in values between participants who were compliant and those who were not was statistically significant. Other factors such as the severity of contracture, the digit involved, and the necessity for capsular release were not significantly related to outcome. The authors concluded that soft tissue responds to continuous dynamic extension stresses and can be remodeled over time.

In a descriptive study, Nuismer and colleagues (1997) retrospectively evaluated a convenience sample of participants at multiple sites using LLPS orthoses for contracture management. The records of 17 participants from skilled nursing facilities, hand clinics, and hospitals were reviewed. There were a total of 18 contractures (2 wrists, 12 elbows, 4 knees) secondary to neurological and orthopedic causes. Chart review focused on participant demographic information, ROM, functional outcomes, and wear schedules. The authors found that the use of LLPS orthoses significantly increased ROM for the whole sample, mean 28.61 degrees (range, -10-66, p<0.001), which in turn significantly improved the participants' functional outcomes. When the sample was divided into two pathology groups to compare a predominately geriatric population with neurological pathologies to a somewhat younger population with a history of musculoskeletal pathology, both groups showed a significant gain in ROM with the use of the LLPS orthoses. The authors concluded that the use of LLPS orthoses for contracture management can mediate the losses in ROM and function that occur with joint contractures.

Lindenhovius (2012) compared the use of dynamic and static progressive (turnbuckle) splints to help stretch a contracted elbow capsule and regain motion after elbow trauma. In a prospective randomized controlled trial, the authors tested the null hypothesis that there is no difference in improvement of motion and Disabilities of the Arm, Shoulder and Hand (DASH) scores between static progressive and dynamic splinting. A total of 66 participants with posttraumatic elbow stiffness were enrolled in a prospective randomized trial: 35 in the static progressive and 31 in the dynamic cohort. Elbow function was measured at enrollment and at 3, 6, and 12 months later and the DASH questionnaire at enrollment and at the 6- and 12-month evaluation. A total of 3 participants asked to be switched to static progressive splinting. The analysis was done according to intention-to-treat principles and with use of mean imputation for missing data. There were no significant differences in flexion arc at any time point. Improvement in the arc of flexion (dynamic vs. static) averaged 29 degrees compared to 28 degrees at 3 months (p=0.87), 40 degrees compared to 39 degrees at 6 months (p=0.72), and 47 degrees compared to 49 degrees at 12 months after splinting was initiated (p=0.71). The average DASH score (dynamic vs. static) was 50 compared to 45 points at enrollment (p=0.52), 32 compared to 25 points at 6 months (p<0.05), and 28 compared to 26 points at 12 months after enrollment (p=0.61). The authors concluded that posttraumatic elbow stiffness can improve with exercises and dynamic or static splinting over a period of 6 to 12 months, and patience is warranted. There were no significant differences in improvement in motion between static progressive and dynamic splinting protocols.

Although there is limited data from controlled trials in the published peer reviewed literature, this technology is widely used by orthopedists as well as occupational and physical therapists for selected populations. Additional input from medical practitioners practicing in relevant clinical areas supports the role of dynamic splinting in the clinical settings outlined under the Clinical Indications section of this document

  Protected motion: A clinical concept which recognizes the importance of protecting damaged tissues as well as the benefits of controlled motion during the early stages of connective tissue repair.

Peer Reviewed Publications:

1. Hepburn GR. Case studies: contracture and stiff joint management with Dynasplint. J Orthop Sports Phys Ther. 1987; 8(10):498-504.
2. Lindenhovius AL, Doornberg JN, Brouwer KM, et al. A prospective randomized controlled trial of dynamic versus static progressive elbow splinting for posttraumatic elbow stiffness. J Bone Joint Surg Am. 2012; 94(8):694-700.
3. 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.
4. Nuismer BA, Ekes AM, Holm MB. The use of low-load prolonged stretch devices in rehabilitation programs in the Pacific Northwest. Am J Occup Ther. 1997; 51(7):538-543.
5. Richard RL, Jones LM, Miller SF, Finley RK Jr. Treatment of exposed bilateral Achilles tendons with use of the Dynasplint. A case report. Phys Ther. 1988; 68(6):989-991.
6. 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. 1992; 17(6):1153-1159.
7. Steffen TM, Mollinger LA. Low-load, prolonged stretch in the treatment of knee flexion contractures in nursing home residents. Phys Ther. 1995; 75(10):886-895

Advance Dynamic ROM
Dynamic Splinting
Dynasplint
JAS Dynamic
Pro-Glide
Spring Loaded Dynamic Splinting

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language including definitions and specific coverage provisions/exclusions, and Medical Policy take precedence over Clinical UM Guidelines and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Clinical UM Guidelines, which address medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Clinical UM Guidelines periodically. Clinical UM guidelines are used when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether or not to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the back of the member's card.

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