A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness

Study Overview
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Brief Summary
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Primary Question: When splinting is used to improve motion in post-traumatic stiff elbows, is there a significant difference in gains in motion achieved between static progressive or dynamic splint approaches? Secondary Question: Is there a significant difference in patient compliance with static progressive versus dynamic splint use, and does this effect final ulnohumeral motion outcomes?

Official Title
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A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness

Conditions
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Post-traumatic Stiff Elbows

Intervention / Treatment
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* Device: Static-Progressive Splint
* Device: Dynamic Splint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients with post-traumatic elbow contractures in the Hand and Upper Extremity Service at Massachusetts General Hospital are eligible to for enrollment in this study regardless of sex, race or ethnicity. Exclusion Criteria: Only English speaking patients will be eligible for the study since questionnaires have not been validated in other languages. Vulnerable populations will not be recruited.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Static-progressive splint<br> | Device: Static-Progressive Splint<br>* Static progressive splinting is a well-established adjunct for restoring elbow motion. Such splints apply a static stress relaxation force to the elbow tissues, which is sequentially increased, as motion is achieved.<br>|
| Experimental: Dynamic Splint<br> | Device: Dynamic Splint<br>* Dynamic splints are a popular alternative, and apply a constant prolonged force to the tissues as additional motion is achieved.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Arc of Flexion and Extension | Active ulnohumeral motion will be measured using a hand-held goniometer by the co-investigator not involved in the care of the patient at enrollment and 6 months after enrollment. | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire | The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elbow, splint