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

Study Overview
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Brief Summary
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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.

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

Conditions
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Median Nerve Compression

Intervention / Treatment
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* Procedure: Pronator Teres Release
* Procedure: dual compression release
* Procedure: dual compression release
* Procedure: median nerve release only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carpal Tunnel and Pronator Teres Release<br>Patients enrolled in this arm of the study will have both surgical procedures performed at the same time | Procedure: dual compression release<br>* both procedures will be done on the same day<br>|
| Active Comparator: Carpal Tunnel Release only<br>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<br>* Surgical release of median nerve compression<br>* Other names: carpal tunnel release;Procedure: dual compression release<br>* Both the carpal tunnel compression and the pronator teres compression will be released on the same day.<br>Procedure: median nerve release only<br>* only the carpal tunnel compression is released<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom severity and functional status score (Brigham and Women's Carpal Tunnel Questionnaire) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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median nerve, carpal tunnel syndrome, Pronator Teres Release