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

This study has been completed.
Sponsor:
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
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241916

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
  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 April 17, 2014