A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness
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|ClinicalTrials.gov Identifier: NCT01241916|
Recruitment Status : Completed
First Posted : November 16, 2010
Results First Posted : July 3, 2012
Last Update Posted : July 3, 2012
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?"
|Condition or disease||Intervention/treatment|
|Post-traumatic Stiff Elbows||Device: Static-Progressive Splint Device: Dynamic Splint|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness|
|Study Start Date :||August 2003|
|Primary Completion Date :||September 2009|
|Study Completion Date :||September 2010|
|Experimental: Static-progressive splint||
Device: Static-Progressive Splint
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.
|Experimental: Dynamic Splint||
Device: Dynamic Splint
Dynamic splints are a popular alternative, and apply a constant prolonged force to the tissues as additional motion is achieved.
- Change in Arc of Flexion and Extension [ Time Frame: baseline and 6 months ]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.
- Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire [ Time Frame: 12 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241916
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|