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Post-operative Mobilization for Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT00435149
Recruitment Status : Completed
First Posted : February 14, 2007
Last Update Posted : February 18, 2011
Sponsor:
Information provided by:
Vanderbilt University

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

Condition or disease Intervention/treatment
Carpal Tunnel Syndrome Procedure: Carpal tunnel release surgery

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post-operative Mobilization for Carpal Tunnel
Study Start Date : December 2006
Primary Completion Date : February 2011
Study Completion Date : February 2011


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Function assessment questionnaire score, pain score questionnaire, and measurements will be used to determine outcome. [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Donald Lee, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00435149     History of Changes
Other Study ID Numbers: 060974
First Posted: February 14, 2007    Key Record Dates
Last Update Posted: February 18, 2011
Last Verified: February 2011

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