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NCT Number: NCT07484100

Efficacy of Proximal Median Nerve Release

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seinäjoki Central Hospital, Seinäjoki, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Global improvement

    Time frame: 6 months

    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)

Secondary outcomes

  1. Global improvement

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

    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)

  2. Global improvement

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

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

  3. Global improvement

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

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

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

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

    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.

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

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

    BCTQ FSS is an 8-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse function. The study will use a Finnish version of the BCTQ FSS.

  6. Questions on proximal nerve symptoms

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

    Question (Likert scale):

    Have you had forearm pain in the past two weeks? (1=No pain; 2=Slight; 3=Medium; 4=Severe; 5=Very serious)

    How often have you had forearm pain in the past two weeks? (1=Normal; 2=1-2 times a week; 3=Daily or almost daily; 4=3-5 times a day; 5=Pain is constant)

    Have you had upper arm pain in the past two weeks? (1=No pain; 2=Slight; 3=Medium; 4=Severe; 5=Very serious)

    Have you had neck or shoulder pain in the past two weeks? (1=No pain; 2=Slight; 3=Medium; 4=Severe; 5=Very serious)

    Do you experience unusual fatigue in your fingers or wrist with exertion? (1=No fatigue; 2=Slight; 3=Medium; 4=Severe; 5=Very serious)

    Higher score indicate worse function.

  7. The use of painkillers

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

    Two questions to patient:

    Have you used painkillers for your upper limb symptoms in the past month? (1=Daily; 2=A few times a week; 3=Once a week; 4=Less than once a week; 5=I have not used painkillers) What painkillers have you used for your symptoms? Select one or more. (None; anti-inflammatory; paracetamol; opioid; neuropathic painkiller; painkiller gel; other)

  8. EUROQOL EQ-5D-5L

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

    The EQ-5D-5L is a widely employed, health-related quality of life instrument comprising five dimensions and a visual VAS for health level. The five dimensions assessed by EQ-5D-5L include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, patients rate their current state on each dimension using a 5-point scale, and the VAS scale ranges from 0 (worst) to 100 (best). Utility or preference weights, applied with an aggregation formula, yield a single index number used to evaluate overall health-related quality of life. It has been proven to be a reliable and validated tool and it is widely used in healthcare research. The EQ-5D-5L has demonstrated good responsiveness in upper extremity conditions, such as distal radius fractures, its responsiveness in hand surgery has not been measured previously. The MID for the index is 0.085 and for the VAS 6.41. Translation and validation for Finnish has been conducted.

  9. Patient reported wrist and hand evaluation (PRWHE)

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

    The PRWHE questionnaire is a wrist and hand -specific instrument comprising a 15-item questionnaire assessing pain and disability in daily living. The questionnaire consists of two subscales (pain and function), and the score ranges from 0 (no disability) to 100 (severe disability). It demonstrates good reliability, validity, and responsiveness. Translation and validation has been conducted for Finnish.

  10. Patient accepted symptom state (PASS)

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

    PASS will be assessed with the statement, "Rate the function of your hand at the moment. I am…very satisfied with the current situation; satisfied; neither satisfied nor dissatisfied; dissatisfied; very dissatisfied." We will also assess whether the patients would choose the same treatment again with the statement, "Would you be willing to undergo the same treatment again if the treatment outcome was the same as it is now? (Yes; No)".

    This type of questionnaire has been shown to have good test-retest reliability and construct validity

  11. Return to work

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

    Two questions to patient: 1) Are you able to work? (I am able to work/ I am unable to work due to this ailment/ I am incapacitated for work due to other ailment) 2) If your incapacity for work due to this ailment has ended, how long did the incapacity for work last?

  12. Adverse effects

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

    Assessed by participant self-reported adverse events.

  13. Questionnaire on the need for treatment

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

    Assessed by participant self-reported information of referral to or executed surgery. The questions are as follows: "Have you had any unexpected post-operative problems that required you to contact healthcare? (Yes; No) Which provider did you contact and for what symptom? Have any surgical procedures been performed on the treated hand outside of research-related visits? (Yes; No) Where and what kind? "

  14. Grip strength

    Time frame: 6 months

    Grip strength (in kilograms) is measured using Jamar dynamometer, providing standardized, reliable data for comparisons. The closer the result is to that of the uninjured hand, the better.

  15. Pinch strength

    Time frame: 6 months

    Key (lateral) pinch strength (in kilograms) is measured using a pinch gauge, thumb pad against the lateral side of the index finger. The closer the result is to that of the uninjured hand, the better.

  16. Standard two-point discrimination

    Time frame: 6 months

    Tests evaluating finger pulp sensitivity are frequently used in clinical practice. S2PD has been used in many digital nerve repair studies, and has good test retest and interobserver reliability, although has received criticism for lack of standardization in previous studies. S2PD normative results depend on the age of the patients, being close to 2mm in younger patients and around 4mm in elderly population. Generally, the lower the result, the better sensation is in the fingertip.

Study contacts

Contact information is provided by the study sponsor or research team.

Henrikki Rönkkö

CONTACT

[email protected]

+3583311611

Jarkko Jokihaara

CONTACT

[email protected]

+3583311611

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Seinajoki Central Hospital

Registry information

Official study title

Efficacy of Operative Versus Conservative Treatment in Proximal Median Nerve Compression

Acronym: PROMER

Important dates

Study start
2026
Primary completion
2036
Study completion
2041
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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