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

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.

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

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.

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