Post-operative Mobilization for Carpal Tunnel Syndrome

Verified by: Vanderbilt University, February 2011
First Received: February 12, 2007 | Last Updated: February 17, 2011 | Phase: N/A | Start Date: December 2006
Overall Status: Completed | Estimated Enrollment: 100
  • …
  • Tell a FriendPrint

This study will investigate the effect of one week of immobilization following carpal tunnel release surgery versus no immobilization...

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: February 2011

Intervention(s) in this Clinical Trial

  • Procedure: Carpal tunnel release surgery
    • Patient will have carpal tunnel release surgery and will be put in a splint after surgery.
  • Procedure: Carpal tunnel release surgery
    • Patient will have carpal tunnel release surgery and will have a bandage placed over the incision site after surgery.

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
  • Active Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Function assessment questionnaire score, pain score questionnaire, and measurements will be used to determine outcome.
    • Time Frame: 6 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Vanderbilt University Other

Overall Clinical Trial Officials and Contacts

Julie Daniels, BBA Study Director VUMC  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00435149

Study ID Number: 060974

ClinicalTrials.gov Identifier: NCT00435149

Health Authority: United States: Institutional Review Board

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00435149