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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Exercise
Other interventionStretching 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
BehavioralPNE 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
Trial outcomes
Primary outcomes
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.
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.
Numerical Rating Scale
Patients rate the current pain intensity from 0 ("no pain") to 10 ("worst possible pain").
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%.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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Karamanoğlu Mehmetbey University
Lead sponsor
Karaman Training and Research Hospital
Collaborator