Back to resultsPost-operative Mobilization for Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carpal tunnel release surgery
Carpal tunnel release surgery
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing open carpal tunnel release will be included in this study.
- Patients must have clinical evidence of carpal tunnel syndrome.
- Patients must have positive EMG results.
- English speaking patients only.
Patient selection factors include:
- Ability and willingness to follow instructions.
- Patients who are able and willing to return for follow-up evaluations.
- Patients of all races and genders.
- Patients who are able to follow care instructions.
Exclusion Criteria:
- Patients less than 18 years old.
- Patients who are pregnant.
- Patients unwilling or unable to comply with a rehabilitation program for carpal tunnel release who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
- Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
Sites / Locations
- Vanderbilt Orthopaedic Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Function assessment questionnaire score, pain score questionnaire, and measurements will be used to determine outcome.
Secondary Outcome Measures
Full Information
NCT ID
NCT00435149
First Posted
February 12, 2007
Last Updated
February 17, 2011
Sponsor
Vanderbilt University
1. Study Identification
Unique Protocol Identification Number
NCT00435149
Brief Title
Post-operative Mobilization for Carpal Tunnel Syndrome
Official Title
Post-operative Mobilization for Carpal Tunnel
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will investigate the effect of one week of immobilization following carpal tunnel release surgery versus no immobilization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Carpal tunnel release surgery
Intervention Description
Patient will have carpal tunnel release surgery and will be put in a splint after surgery.
Intervention Type
Procedure
Intervention Name(s)
Carpal tunnel release surgery
Intervention Description
Patient will have carpal tunnel release surgery and will have a bandage placed over the incision site after surgery.
Primary Outcome Measure Information:
Title
Function assessment questionnaire score, pain score questionnaire, and measurements will be used to determine outcome.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing open carpal tunnel release will be included in this study.
Patients must have clinical evidence of carpal tunnel syndrome.
Patients must have positive EMG results.
English speaking patients only.
Patient selection factors include:
Ability and willingness to follow instructions.
Patients who are able and willing to return for follow-up evaluations.
Patients of all races and genders.
Patients who are able to follow care instructions.
Exclusion Criteria:
Patients less than 18 years old.
Patients who are pregnant.
Patients unwilling or unable to comply with a rehabilitation program for carpal tunnel release who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Daniels, BBA
Organizational Affiliation
VUMC
Official's Role
Study Director
Facility Information:
Facility Name
Vanderbilt Orthopaedic Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-8828
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Post-operative Mobilization for Carpal Tunnel Syndrome
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