Efficacy of Proximal Median Nerve Release

NCT07484100 | Not Yet Recruiting DMC

• 1 other identifier: R23045
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Median Nerve Compression; Median Nerve Entrapment; Carpal Tunnel Surgery

Keywords

proximal median nerve entrapment; proximal median nerve compression; proximal median nerve release; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Global improvement

  Question to patient (Likert scale): Have your symptoms been better in the last week than before the beginning of treatment? (much better; better; a little better; no change; a little worse; worse; much worse)

  6 months

Secondary Outcomes (16)

• Global improvement

  3 months, and 1, 2, 5 years

• Global improvement

  3 and 6 months, and 1, 2, and 5 years

• Global improvement

  3 and 6 months, and 1, 2, and 5 years

• The Boston Carpal Tunnel Questionnaire Symptom Severity Scale scores (BCTQ SSS)

  3 and 6 months, and 1, 2, and 5 years

• The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS)

  3 and 6 months, and 1, 2, and 5 years

Study Arms (2)

Proximal median nerve release

EXPERIMENTAL

Operative treatment: proximal median nerve release

Procedure: Proximal median nerve release; Other: Physiotherapy

Physiotherapy

ACTIVE COMPARATOR

Conservative treatment: physiotherapy

Other: Physiotherapy

Interventions

Proximal median nerve release PROCEDURE

Participants randomized to operative treatment will be scheduled for surgery. During surgery, the proximal median nerve compression will be released in a manner deemed best by the treating surgeon. Patients randomized to surgery will also receive conservative management following surgery.

Proximal median nerve release

Physiotherapy OTHER

Participants randomized to conservative treatment will receive information about median nerve compression and written instructions for self-directed nerve stretching exercises. There will be one supervision visit with a physiotherapist at the beginning of the treatment period.

Physiotherapy; Proximal median nerve release

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tampere University Hospital: lead
• Seinajoki Central Hospital: collaborator

Study Sites (2)

Seinäjoki Central Hospital

Seinäjoki, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Median Neuropathy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Jarkko Jokihaara

CONTACT

+3583311611; jarkko.jokihaara@pirha.fi

Henrikki Rönkkö

CONTACT

+3583311611; henrikki.ronkko@pirha.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 19, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2036
• Study Completion (Estimated): July 1, 2041
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available after the trial conclusion. All data will be retained for fifteen years following the conclusion of the trial.
• Access Criteria: Summary statistics may be shared outside the study group if reasonable request is received - for example, for meta analysis purposes.

Locations

FI (2)