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Not yet recruiting NCT07484100

Efficacy of Proximal Median Nerve Release

No phase Interventional Carpal Tunnel Surgery Median Nerve Compression Median Nerve Entrapment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Proximal median nerve release, Physiotherapy.
Who it may be relevant to
Registry conditions: Carpal Tunnel Surgery, Median Nerve Compression, Median Nerve Entrapment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy of Operative Versus Conservative Treatment in Proximal Median Nerve Compression

Overview

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.

Interventions

  • Procedure Proximal median nerve release
    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.
  • Other Physiotherapy
    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.

Primary outcome measures

  • Global improvement [Time frame: 6 months]
Secondary outcome measures (12)
  • Global improvement [Time frame: 3 months, and 1, 2, 5 years]
  • Global improvement [Time frame: 3 and 6 months, and 1, 2, and 5 years]
  • Global improvement [Time frame: 3 and 6 months, and 1, 2, and 5 years]
  • The Boston Carpal Tunnel Questionnaire Symptom Severity Scale scores (BCTQ SSS) [Time frame: 3 and 6 months, and 1, 2, and 5 years]
  • The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS) [Time frame: 3 and 6 months, and 1, 2, and 5 years]
  • Questions on proximal nerve symptoms [Time frame: 3 and 6 months, and 1, 2, and 5 years]
  • The use of painkillers [Time frame: 3 and 6 months, and 1, 2, and 5 years]
  • EUROQOL EQ-5D-5L [Time frame: 3 and 6 months, and 1, 2, and 5 years]
  • Patient reported wrist and hand evaluation (PRWHE) [Time frame: 3 and 6 months, and 1, 2, and 5 years]
  • Patient accepted symptom state (PASS) [Time frame: 3 and 6 months, and 1, 2, and 5 years]
  • Return to work [Time frame: 3 and 6 months, and 1, 2, and 5 years]
  • Adverse effects [Time frame: 3 and 6 months, and 1, 2, and 5 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Finland · 2 centers
  • Seinäjoki Central Hospital — Seinäjoki
  • Tampere University Hospital — Tampere

Identifiers

NCT: NCT07484100 · R23045

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗