- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00435149
Post-operative Mobilization for Carpal Tunnel Syndrome
February 17, 2011 updated by: Vanderbilt University
Post-operative Mobilization for Carpal Tunnel
This study will investigate the effect of one week of immobilization following carpal tunnel release surgery versus no immobilization.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232-8828
- Vanderbilt Orthopaedic Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
|
Patient will have carpal tunnel release surgery and will be put in a splint after surgery.
Patient will have carpal tunnel release surgery and will have a bandage placed over the incision site after surgery.
|
Active Comparator: 1
|
Patient will have carpal tunnel release surgery and will be put in a splint after surgery.
Patient will have carpal tunnel release surgery and will have a bandage placed over the incision site after surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Function assessment questionnaire score, pain score questionnaire, and measurements will be used to determine outcome.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Julie Daniels, BBA, VUMC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
February 12, 2007
First Submitted That Met QC Criteria
February 12, 2007
First Posted (Estimate)
February 14, 2007
Study Record Updates
Last Update Posted (Estimate)
February 18, 2011
Last Update Submitted That Met QC Criteria
February 17, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 060974
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carpal Tunnel Syndrome
-
Stanford UniversityMayo Clinic; Brown University; Duke University; Harvard University; University of...CompletedCarpal Tunnel Syndrome | Carpal Tunnel | Carpal Tunnel Syndrome Bilateral | Carpal Tunnel Syndrome Left | Carpal Tunnel Syndrome RightUnited States
-
Issa, Abdulhamid Sayed, M.D.CompletedCarpal Tunnel Syndrome | CTS | Carpal Tunnel Release | Carpal Tunnel Surgery | Carpal Tunnel Transverse ApproachSyrian Arab Republic
-
University of Split, School of MedicineCompletedCarpal Tunnel Syndrome BilateralCroatia
-
Ohio State UniversityCompletedBilateral Carpal Tunnel Syndrome (Diagnosis)United States
-
CMC Ambroise ParéCompletedCarpal Tunnel ReleaseFrance
-
Vanderbilt UniversityOrthopedic Research and Education FoundationCompleted
-
University of PittsburghWithdrawnPain After Carpal Tunnel ReleaseUnited States
-
Centre Hospitalier Saint Joseph Saint Luc de LyonRecruitingCarpal Tunnel Syndrome BilateralFrance
-
Istituto Ortopedico RizzoliCompletedEntrapment Neuropathy, Carpal Tunnel | Compression Neuropathy, Carpal Tunnel | Median Neuropathy, Carpal TunnelItaly
-
David TangRecruitingCarpal Tunnel Syndrome | Splints | Carpal Tunnel | Nerve Compression | Carpal Tunnel Release | Hand Injuries and DisordersCanada
Clinical Trials on Carpal tunnel release surgery
-
Vanderbilt UniversityTerminated
-
Kaohsiung Medical UniversityCompletedCarpal Tunnel SyndromeTaiwan
-
Henry Ford Health SystemRecruiting
-
Region SkaneCompleted
-
Penn State UniversityCompletedCarpal Tunnel SyndromeUnited States
-
Yonsei UniversityCompletedIdiopathic Carpal Tunnel SyndromeKorea, Republic of
-
Mansoura UniversityCompletedCarpal Tunnel Syndrome | IncisionEgypt
-
The Second Hospital of QinhuangdaoCompletedCarpal Tunnel SyndromeChina
-
Gelre HospitalsDeventer ZiekenhuisRecruitingCarpal Tunnel Syndrome | Wound Infection | Suture, ComplicationNetherlands
-
Sonex Health, Inc.Terminated