The Effectiveness of Pain Neuroscience Education for Patients With Carpal Tunnel Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaramanoğlu Mehmetbey University

About this trial

The goal of this clinical trial is to investigate the effects of Pain Neuroscience Education applied in the treatment of mild and moderate carpal tunnel syndrome (CTS).

The main question it aims to answer is: Does PNE have a therapeutic effect on carpal tunnel syndrome in clinical and ultrasonographic terms? Researchers will compare whether PNE creates a synergistic effect alongside home based exercise programs and splint application in mild to moderate CTS, and will objectively demonstrate potential benefits such as relief from pain and numbness.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being 18 years of age or older

Having a diagnosis of mild or moderate CTS confirmed by ENMG

Having complaints of pain and numbness in the first three fingers of the hand for at least 3 months

Disqualifiers

Presence of severe CTS findings on electrophysiological examination

Presence of metabolic diseases such as uncontrolled diabetes and hypothyroidism

Presence of inflammatory rheumatic disease (e.g., rheumatoid arthritis)

Presence of other neuromuscular diseases affecting the hand and wrist (Polyneuropathy, Cervical radiculopathy, peripheral nerve damage, Brachial plexus damage, other entrapment neuropathies, etc.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Other intervention

    Stretching the transverse carpal ligament helps correct imbalance and provides more space for the median nerve, supporting nerve mobility. Stretching also balances flexor and extensor muscles, reduces tension, and supports overall hand health. Nerve gliding exercises, similar to stretching, aim to restore nerve mobility and reduce symptoms.

  • Pain neuroscience education

    Behavioral

    PNE is an educational intervention aiming to alter a patient's beliefs and cognitions regarding their pain experience. The main contents addressed in the educational session were: neurophysiological aspects of pain, biopsychosocial aspects of pain, concept of peripheral and central sensitization, using audio-visual support, examples and metaphors for a better understanding by the patient, as reported in previous studies.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Group 1 (home based exercise program)Active comparator 1 intervention
Group B: Group 2 (home based exercise program and pain neuroscience education)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Boston Carpal Tunnel Questionnaire - Symptom Severity Scale

Symptom Severity Scale is an 11-item questionnaire used to assess symptom severity in individuals with CTS. Each item is scored from 1 to 5. Scores range from 1 (no symptoms) to 5 (worst symptoms). The patient's symptom severity score is the average score of 11 items.

Time frame
Baseline, in the 3rd week and in the 6th week
2

Boston Carpal Tunnel Questionnaire - Functional Status Scale

Functional Status Scale is an 8-item questionnaire used to assess the functional status of patients with CTS. Each item is scored from 1 to 5. Scores range from 1 (no functional deficit) to 5 (worst possible function). The patient's functional status score is the average of all 8 items.

Time frame
Baseline, in the 3rd week and in the 6th week
3

Numerical Rating Scale

Patients rate the current pain intensity from 0 ("no pain") to 10 ("worst possible pain").

Time frame
Baseline, in the 3rd week and in the 6th week
4

6-item carpal tunnel syndrome symptom scale (CTS-6)

6 items are evaluated out of a total of 26 points. If the patient's total score is above 5, the probability of carpal tunnel syndrome is 25%, while if it is above 12, the probability reaches 80%.

Time frame
Baseline, in the 3rd week and in the 6th week

Secondary outcomes

1

Ultrasound median nerve cross-sectional area

The cross-sectional area of the median nerve is significantly higher in CTS patients compared to the normal population. Ultrasound, which is used to evaluate the median nerve and determine the underlying etiology, is also used to monitor the effectiveness of the treatment. The cross-sectional area measurement of the median nerve will be recorded in mm².

Time frame
Baseline, in the 3rd week and in the 6th week
2

Semmes-Weinstein Monofilament Test

It is used to assess light touch sensation. The assessment is performed using 5 separate monofilaments. The numerical value in the test kits represents the logarithm of 10 times the force required to bend the monofilament, expressed in milligrams. The numerical values are 2.83 (normal light touch sensation), 3.61 (decreased light touch), 4.31 (decreased protective sensation), 4.56 (loss of protective sensation), and 6.65 (loss of deep pressure sensation). The test is performed by applying the monofilament to the tip of the index finger at a 90-degree angle to the skin for 1.5 seconds, repeated three times. The patient must perceive at least one of the monofilament applications as normal. Failure to perceive the 2.83 threshold value is significant for carpal tunnel syndrome.

Time frame
Baseline, in the 3rd week and in the 6th week
3

Two-Point Discrimination Test (2PD)

It is used to assess cortical tactile sensation. The test is applied to the lateral part of the volar surface of the index finger tip. During the test, patients are asked to close their eyes and indicate whether they feel a single or double point. To prevent incorrect sensory perception, pressure exceeding 1 mm is not applied to the skin. The distance between the two points is increased by 1 mm at a time, starting from 1 mm, until the patient feels two distinct points. In the evaluation, a measurement value perceived as two points is considered normal if it is below 6 mm. The minimum distance between two points that can be distinguished by an individual will be tested three times at 1-minute intervals, and the average value will be recorded in centimeters.

Time frame
Baseline, in the 3rd week and in the 6th week
4

Quantitative sensory evaluation

Starting at 32 °C, the Cold Detection Threshold is cooled at a rate of 1 °C per second, and the patient presses the button when they first feel the cold. For the Heat Detection Threshold, the temperature is heated at a rate of 1 °C per second, and the patient presses the button when they first feel the heat. For the cold pain threshold, it is cooled at a rate of 1 °C per second, and the patient presses the button when they feel cold pain. For the hot pain threshold, it is heated at a rate of 1 °C per second, and the patient presses the button when they feel hot pain. Each measurement is taken 3 times, and the average value is recorded in degrees Celsius.

Time frame
Baseline, in the 3rd week and in the 6th week

Other outcomes

Sponsors and contacts

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Karamanoğlu Mehmetbey University

Lead sponsor

Karaman Training and Research Hospital

Collaborator