Efficacy of Proximal Median Nerve Release (PROMER)

Efficacy of Operative Versus Conservative Treatment in Proximal Median Nerve Compression

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Median Nerve Compression; Median Nerve Entrapment; Carpal Tunnel Surgery
• Intervention / Treatment: Procedure: Proximal median nerve release; Other: Physiotherapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jarkko Jokihaara; Phone Number: +3583311611; Email: jarkko.jokihaara@pirha.fi
• Study Contact Backup: Name: Henrikki Rönkkö; Phone Number: +3583311611; Email: henrikki.ronkko@pirha.fi

Study Locations

• Finland
  • Seinäjoki, Finland
    • Seinäjoki Central Hospital
    • Contact: Pekka Löppönen; Phone Number: +3586 4154111; Email: pekka.lopponen@hyvaep.fi
  • Tampere, Finland
    • Tampere University Hospital
    • Contact: Henrikki Rönkkö; Phone Number: +3583311611; Email: henrikki.ronkko@pirha.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proximal median nerve release; Operative treatment: proximal median nerve release	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.
Active Comparator: Physiotherapy; Conservative treatment: physiotherapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 months, and 1, 2, 5 years
Global improvement	Question to patient (dichotomous): Do you feel your symptoms have completely improved? (Yes; No)	3 and 6 months, and 1, 2, and 5 years
Global improvement	Question to patient (scale 0-100): Rate the function of your hand at the moment. (scale 0-100, normal - very symptomatic)	3 and 6 months, and 1, 2, and 5 years
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.	3 and 6 months, and 1, 2, and 5 years
The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS)	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.	3 and 6 months, and 1, 2, and 5 years
Questions on proximal nerve symptoms	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.	3 and 6 months, and 1, 2, and 5 years
The use of painkillers	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)	3 and 6 months, and 1, 2, and 5 years
EUROQOL EQ-5D-5L	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.	3 and 6 months, and 1, 2, and 5 years
Patient reported wrist and hand evaluation (PRWHE)	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.	3 and 6 months, and 1, 2, and 5 years
Patient accepted symptom state (PASS)	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	3 and 6 months, and 1, 2, and 5 years
Return to work	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?	3 and 6 months, and 1, 2, and 5 years
Adverse effects	Assessed by participant self-reported adverse events.	3 and 6 months, and 1, 2, and 5 years
Questionnaire on the need for treatment	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? "	3 and 6 months, and 1, 2, and 5 years
Grip strength	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.	6 months
Pinch strength	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.	6 months
Standard two-point discrimination	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.	6 months

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Seinajoki Central Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 1, 2036
• Study Completion (Estimated): July 1, 2041

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; proximal median nerve entrapment; proximal median nerve compression; proximal median nerve release
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Mononeuropathies; Median Neuropathy; Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: R23045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On request and if current legislation allows, we will provide the anonymized data of the study.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Summary statistics may be shared outside the study group if reasonable request is received - for example, for meta analysis purposes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No