Post-operative Mobilization for Carpal Tunnel Syndrome

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00435149
First received: February 12, 2007
Last updated: February 17, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention
Carpal Tunnel Syndrome
Procedure: Carpal tunnel release surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post-operative Mobilization for Carpal Tunnel

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Function assessment questionnaire score, pain score questionnaire, and measurements will be used to determine outcome. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2006
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Procedure: Carpal tunnel release surgery
Patient will have carpal tunnel release surgery and will be put in a splint after surgery.
Active Comparator: 2 Procedure: Carpal tunnel release surgery
Patient will have carpal tunnel release surgery and will have a bandage placed over the incision site after surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435149

Locations
United States, Tennessee
Vanderbilt Orthopaedic Institute
Nashville, Tennessee, United States, 37232-8828
Sponsors and Collaborators
Vanderbilt University
Investigators
Study Director: Julie Daniels, BBA VUMC
  More Information

No publications provided

Responsible Party: Dr. Donald Lee, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00435149     History of Changes
Other Study ID Numbers: 060974
Study First Received: February 12, 2007
Last Updated: February 17, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on July 23, 2014