Carpal Tunnel SurgeryPROMERNCT07484100
Efficacy of Proximal Median Nerve Release
A study testing Proximal median nerve release and Physiotherapy in people with Carpal Tunnel Surgery and Median Nerve Compression, run by Tampere University Hospital at 2 sites in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Surgery, Median Nerve Compression, Median Nerve Entrapment
- What is being tested?
- Proximal median nerve release and Physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesFinland
- Study dates
- 1 Mar 2026to Jul 2041
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites
Seinäjoki Central Hospital
Seinäjoki
Pekka Löppönen, +3586 4154111, pekka.lopponen@hyvaep.fi
Tampere University Hospital
Tampere
Henrikki Rönkkö, +3583311611, henrikki.ronkko@pirha.fi
About this study
Official title: 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.
Read the 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.
- Being tested
- Proximal median nerve release, Physiotherapy
- Keywords
- proximal median nerve entrapment, proximal median nerve compression, proximal median nerve release, randomized controlled trial
- Medical subject headings
- Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal median nerve releaseProcedure or 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.
PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Proximal median nerve release | Experimental | Operative treatment: proximal median nerve release Receives: Procedure: Proximal median nerve release; Other: Physiotherapy |
| Physiotherapy | Active comparator | Conservative treatment: physiotherapy Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (16)
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)
Measured: 3 months, and 1, 2, 5 years
Global improvement
Question to patient (dichotomous): Do you feel your symptoms have completely improved? (Yes; No)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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?
Measured: 3 and 6 months, and 1, 2, and 5 years
Adverse effects
Assessed by participant self-reported adverse events.
Measured: 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? "
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completionDec 2036 (estimated)
- Study completionJul 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SurgeryStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seinajoki Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484100
- Sponsor's protocol ID
- R23045
- Acronym
- PROMER
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request and if current legislation allows, we will provide the anonymized data of the study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Operative Versus Conservative Treatment in Proximal Median Nerve Compression
- ClinicalTrials.gov ID
- NCT07484100
- Acronym / sponsor ID
- PROMER / R23045
- Keywords
- proximal median nerve entrapment, proximal median nerve compression, proximal median nerve release, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Seinajoki Central Hospital
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- Dec 2036 (estimated)
- Study completion
- Jul 2041 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal median nerve release | Experimental | Procedure: Proximal median nerve release, Other: PhysiotherapyOperative treatment: proximal median nerve release |
| Physiotherapy | Active comparator | Other: PhysiotherapyConservative treatment: physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proximal median nerve releaseParticipants 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. | Procedure or surgery | Proximal median nerve release |
| PhysiotherapyParticipants 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. | Other | Physiotherapy, Proximal median nerve release |
Primary outcome
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)
16 secondary outcomes
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
Questionnaire on the need for treatment
Time frame: 3 and 6 months, and 1, 2, and 5 years
Grip strength
Time frame: 6 months
Pinch strength
Time frame: 6 months
Standard two-point discrimination
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Yes. On request and if current legislation allows, we will provide the anonymized data of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal median nerve release and Physiotherapy in people with Carpal Tunnel Surgery and Median Nerve Compression, run by Tampere University Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jarkko Jokihaara (+3583311611, jarkko.jokihaara@pirha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global improvement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.