A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness
This study has been completed.
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01241916
First received: November 15, 2010
Last updated: May 30, 2012
Last verified: May 2012
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Purpose
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 | Intervention |
|---|---|
|
Post-traumatic Stiff Elbows |
Device: Static-Progressive Splint Device: Dynamic Splint |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness |
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Change in Arc of Flexion and Extension [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
| Enrollment: | 66 |
| Study Start Date: | August 2003 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | David C. Ring, MD, Director of Research, Hand Service, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01241916 History of Changes |
| Other Study ID Numbers: | 2003P001441 |
| Study First Received: | November 15, 2010 |
| Results First Received: | April 16, 2012 |
| Last Updated: | May 30, 2012 |
| Health Authority: | USA: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
elbow, splint |
ClinicalTrials.gov processed this record on May 22, 2013