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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor:
Information provided by (Responsible Party):
Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier:
NCT01562860
First received: August 8, 2011
Last updated: July 9, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Median Nerve Compression
Procedure: Pronator Teres Release
Procedure: dual compression release
Procedure: median nerve release only
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Influence of Pronator Teres Release in the Treatment of Median Nerve Compression Neuropathy: A Randomized Prospective Study

Resource links provided by NLM:


Further study details as provided by Christine M. Kleinert Institute for Hand and Microsurgery:

Primary Outcome Measures:
  • Symptom severity and functional status score (Brigham and Women's Carpal Tunnel Questionnaire) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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: Pronator Teres Release
Surgical release of median nerve compression
Other Name: carpal tunnel release
Procedure: dual compression release
Both the carpal tunnel compression and the pronator teres compression will be released on the same day.
Procedure: median nerve release only
only the carpal tunnel compression is released

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  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: NCT01562860

Contacts
Contact: Tuna Ozyurekoglu, MD 502-561-4263 tozyurekoglu@cmki.org
Contact: Ross D Gibson, BA 502-562-0307 rgibson@cmki.org

Locations
United States, Kentucky
Christine M. Kleinert Institute for Hand and Microsurgery Recruiting
Louisville, Kentucky, United States, 40202
Contact: Christina L Kaufman, PhD    502-562-0390    ckaufman@cmki.org   
Contact: Ross D Gibson, BA    502-562-0307    rgibson@cmki.org   
Principal Investigator: Tuna Ozyurekoglu, MD         
Sponsors and Collaborators
Christine M. Kleinert Institute for Hand and Microsurgery
Investigators
Principal Investigator: Tuna Ozyurekoglu, MD Christine M. Kleinert Institute for Hand and Microsurgery
  More Information

No publications provided

Responsible Party: Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier: NCT01562860     History of Changes
Other Study ID Numbers: 10.0039
Study First Received: August 8, 2011
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Christine M. Kleinert Institute for Hand and Microsurgery:
median nerve
carpal tunnel syndrome
Pronator Teres Release

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Nerve Compression Syndromes
Charcot-Marie-Tooth Disease
Hereditary Sensory and Motor Neuropathy
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Congenital Abnormalities
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 26, 2014