Median Nerve Compression Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | July 2019 |
| Est. primary completion date | July 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
- 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Christine M. Kleinert Institute for Hand and Microsurgery | Louisville | Kentucky |
| Lead Sponsor | Collaborator |
|---|---|
| Christine M. Kleinert Institute for Hand and Microsurgery |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |