Post-operative Mobilization for Carpal Tunnel Syndrome

NCT ID: NCT00435149

Last Updated: 2011-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2011-02-28

Brief Summary

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

Detailed Description

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Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Carpal tunnel release surgery

Intervention Type PROCEDURE

Patient will have carpal tunnel release surgery and will be put in a splint after surgery.

2

Group Type ACTIVE_COMPARATOR

Carpal tunnel release surgery

Intervention Type PROCEDURE

Patient will have carpal tunnel release surgery and will have a bandage placed over the incision site after surgery.

Interventions

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Carpal tunnel release surgery

Patient will have carpal tunnel release surgery and will be put in a splint after surgery.

Intervention Type PROCEDURE

Carpal tunnel release surgery

Patient will have carpal tunnel release surgery and will have a bandage placed over the incision site after surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Vanderbilt University

Principal Investigators

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Julie Daniels, BBA

Role: STUDY_DIRECTOR

VUMC

Locations

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Vanderbilt Orthopaedic Institute

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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060974

Identifier Type: -

Identifier Source: org_study_id

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