Post-operative Mobilization for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Post-operative Mobilization for Carpal Tunnel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435149
• Other study ID #: 060974
• Status: Completed
• Phase: N/A
• First received: February 12, 2007
• Last updated: February 17, 2011
• Start date: December 2006
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt Orthopaedic Institute	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function assessment questionnaire score, pain score questionnaire, and measurements will be used to determine outcome.		6 months	No