Influence of Pronator Teres Release on Treatment of Median Nerve Compression Neuropathy
This study is currently recruiting participants.
Verified January 2013 by Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor:
Christine M. Kleinert Institute for Hand and Microsurgery
Information provided by (Responsible Party):
Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier:
NCT01562860
First received: August 8, 2011
Last updated: January 30, 2013
Last verified: January 2013
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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:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562860
Contacts
| Contact: Tuna Ozyurekoglu, MD | 502-561-4263 | tozyurekoglu@cmki.org |
| Contact: Rebecca E Jones, BA | 502-562-0307 | rjones@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: Sara Sanders, BA 502-562-0307 ssanders@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: | January 30, 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:
|
Hereditary Sensory and Motor Neuropathy Median Neuropathy Carpal Tunnel Syndrome Charcot-Marie-Tooth Disease Nerve Compression Syndromes 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 May 22, 2013