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ClinicalTrials.gov ID

NCT07484100

Lead Sponsor

Tampere University HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

160Estimated

Last Update Posted

Mar 19, 2026Actual

Start Date

Mar 1, 2026Estimated

Primary Completion Date

Dec 2036Estimated

Completion Date

Jul 2041Estimated

Official Title

Efficacy of Operative Versus Conservative Treatment in Proximal Median Nerve Compression

Brief Summary

A multi-center randomized controlled clinical trial which determines the efficacy of proximal median nerve release in patients with persistent proximal median nerve compression. The primary outcome is patient reported improvement of symptoms on a 7-point Likert scale at 6 months after the randomization to treatment group.

Detailed Description

Carpal tunnel surgery is one of the most common surgeries in upper extremity. Most patients benefit from carpal tunnel surgery, but some patients complain weakness and pain symptoms after surgery. According to a case series by Özdemir et al. (2020), after carpal tunnel surgery up to 13% of patients were diagnosed with proximal median nerve compression. Proximal median nerve compression is a poorly known and recognized condition that is likely to be underdiagnosed. Surgical treatment has become more common in recent years even though the effect of surgical treatment is unclear at the moment.

The planned multi-center randomized controlled clinical trial determines the efficacy of proximal median nerve release in patients with persistent proximal median nerve compression. The primary outcome is patient reported improvement of symptoms on a 7-point Likert scale at 6 months after the randomization to treatment group.

• Carpal Tunnel Surgery
• Median Nerve Compression
• Median Nerve Entrapment

• Proximal median nerve release
• Physiotherapy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Clinically diagnosed PMNC
2. If the patient has clinically and electrodiagnostically confirmed carpal tunnel syndrome, at least 6 months must have passed since surgical treatment
3. Age 18 or over
4. Ability to understand Finnish
5. Ability to complete electronic questionnaires independently
6. Willingness to participate in research and follow research instructions
7. Provision of informed consent from the participant

Exclusion Criteria:

1. Nerve root disorder findings in ENMG
2. Thoracic outlet syndrome, TOS
3. Other neurological condition that causes upper limb symptoms such as MS, previous nerve injury
4. Active rheumatoid arthritis or any other active inflammatory joint disease that affects hand function
5. Significant compression symptoms of another peripheral nerve in association with PMNC
6. Other upper extremity operation performed less than 6 months ago
7. Another disease or condition that accounts for most of the patient's symptoms
8. Other known reasons that may prevent participation or implementation of treatment during the study

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Tampere University HospitalOTHER

Collaborators

Seinajoki Central HospitalOTHER

henrikki.ronkko@pirha.fi+3583311611