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

Christine M. Kleinert Institute for Hand and Microsurgery

Status and phase: Unknown; Phase 2

Conditions: Median Nerve Compression

Treatments: Procedure: median nerve release only; Procedure: dual compression release; Procedure: Pronator Teres Release

Study type: Interventional

Funder types: Other

Identifiers

NCT01562860

10.0039

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Carpal Tunnel and Pronator Teres Release

Active Comparator group

Description:

Patients enrolled in this arm of the study will have both surgical procedures performed at the same time

Treatment:

Procedure: dual compression release

Procedure: dual compression release

Carpal Tunnel Release only

Active Comparator group

Description:

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.

Treatment:

Procedure: Pronator Teres Release

Procedure: median nerve release only

Procedure: dual compression release

Procedure: dual compression release