Influence of Pronator Teres Release on Treatment of Median Nerve Compression Neuropathy

January 23, 2018 updated by: Christine M. Kleinert Institute for Hand and Microsurgery

The Influence of Pronator Teres Release in the Treatment of Median Nerve Compression Neuropathy: A Randomized Prospective Study

The investigators are comparing two standard of care procedures which can be performed at the same time, or sequentially. The hypothesis being tested is whether simultaneous release of both the carpal Tunnel and the Pronator Teres results in a better outcome in terms of symptom relief and recurrence than Carpal Tunnel Release alone when signs and symptoms of both carpal tunnel and pronator Teres syndromes are present.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Millicent L Horn, BS
  • Phone Number: 502-562-0307
  • Email: mhorn@cmki.org

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Christine M. Kleinert Institute for Hand and Microsurgery
        • Contact:
          • Millicent L Horn, BS
          • Phone Number: 502-562-0307
          • Email: mhorn@cmki.org

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

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Inclusion Criteria: Positive Tinnels signs over the median nerve at the Carpal Tunnel and Pronator Teres
  • Normal two point discrimination
  • Over the age of 18 and under the age of 65

Exclusion Criteria:

  • Peripheral neuropathy of the median nerve secondary to trauma
  • Presence of thoracic outlet syndrome
  • Presence of cervical disk disease
  • Under the age of 18 and over the age of 65

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Carpal Tunnel and Pronator Teres Release
Patients enrolled in this arm of the study will have both surgical procedures performed at the same time
Procedure: dual compression release
Both the carpal tunnel compression and the pronator teres compression will be released on the same day.
Procedure: dual compression release
both procedures will be done on the same day
Active Comparator: Carpal Tunnel Release only
Patients enrolled in this arm will have only Carpal Tunnel Release performed. In they still have symptoms of median nerve neuropathy, they will be scheduled for an additional procedure to release the pronator Teres in a separate surgery.
Procedure: dual compression release
Both the carpal tunnel compression and the pronator teres compression will be released on the same day.
Procedure: dual compression release
both procedures will be done on the same day
Procedure: Pronator Teres Release
Surgical release of median nerve compression
Other Names:
  • carpal tunnel release
Procedure: median nerve release only
only the carpal tunnel compression is released

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom severity and functional status score (Brigham and Women's Carpal Tunnel Questionnaire)
Time Frame: 12 months
The primary outcome measure will be the difference between the pre and post operative assessments of the questionnaire, which will represent the degree of improvement as result of the surgical intervention.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christine M. Kleinert Institute for Hand and Microsurgery

Investigators

  • Principal Investigator: Tuna Ozyurekoglu, MD, Christine M. Kleinert Institute for Hand and Microsurgery

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

July 1, 2010

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

August 8, 2011

First Submitted That Met QC Criteria

March 22, 2012

First Posted (Estimate)

March 26, 2012

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10.0039

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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