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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014