Health TrialsbyHealthPanel

Efficacy of Proximal Median Nerve Release

ConditionsCarpal Tunnel SurgeryMedian Nerve CompressionMedian Nerve Entrapment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTampere University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Proximal median nerve release

    Procedure/Surgery

    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.

  • Physiotherapy

    Other intervention

    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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Proximal median nerve releaseExperimental treatment 2 interventions
Group B: PhysiotherapyActive comparator 1 intervention

Trial outcomes

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)

Time frame
6 months

Secondary 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)

Time frame
3 months, and 1, 2, 5 years
2

Global improvement

Question to patient (dichotomous): Do you feel your symptoms have completely improved? (Yes; No)

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

Global improvement

Question to patient (scale 0-100): Rate the function of your hand at the moment. (scale 0-100, normal - very symptomatic)

Time frame
3 and 6 months, and 1, 2, and 5 years
4

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

BCTQ SSS is an 11-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse symptoms. The study will use a Finnish version of the BCTQ SSS.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tampere University Hospital

Lead sponsor

Seinajoki Central Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: