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| Name | Class |
|---|---|
| Seinajoki Central Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proximal median nerve release | Experimental | Operative treatment: proximal median nerve release |
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| Physiotherapy | Active Comparator | Conservative treatment: physiotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jarkko Jokihaara | Contact | +3583311611 | jarkko.jokihaara@pirha.fi | |
| Henrikki Rönkkö | Contact | +3583311611 | henrikki.ronkko@pirha.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seinäjoki Central Hospital | Seinäjoki | Finland |
On request and if current legislation allows, we will provide the anonymized data of the study.
The data will be available after the trial conclusion. All data will be retained for fifteen years following the conclusion of the trial.
Summary statistics may be shared outside the study group if reasonable request is received - for example, for meta analysis purposes.
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| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| 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. |
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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 |
| Tampere University Hospital | Tampere | Finland |
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