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||Phase|
|Post-traumatic Stiff Elbows||Device: Static-Progressive Splint Device: Dynamic Splint||Not Applicable|
|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|
|Actual Primary Completion Date :||September 2009|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241916
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|