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Carpal Tunnel Syndrome (CTS)NCT07302282

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

A study testing Exercise and Pain neuroscience education in people with Carpal Tunnel Syndrome (CTS), run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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?… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carpal Tunnel Syndrome (CTS)
What is being tested?
Exercise and Pain neuroscience education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
29 Dec 2025to 31 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

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

  • 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

Who cannot join

  • 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.)
  • History of hand and wrist trauma
  • History of neck and wrist surgery
Show all 11Show fewer
  • History of steroid injection into the carpal tunnel within the last 3 months
  • History of physical therapy application to wrist within the last 3 months
  • Deformity preventing the use of a splint on the wrist
  • Previous participation in a program for the psychological management of chronic pain
  • Cognitive dysfunction preventing cooperation with tests

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Karaman Training and Research Hospital

    Karaman, Karaman, 70200

Other trials in Turkey (Türkiye)

About this study

Official title: The Effectiveness of Pain Neuroscience Education for Patients With Mild to Moderate Carpal Tunnel Syndrome

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.

Read the detailed description

Carpal Tunnel Syndrome (CTS) is a common compressive neuropathy of the median nerve that presents with symptoms of numbness and tingling in the median nerve distribution of the hand. If symptoms are not treated early, they become chronic. Factors affecting the severity of chronic pain include; biological, psychological and social/environmental etc.

Pain neuroscience education is a treatment strategy that aims to teach patients about the effects of their beliefs and behaviors on the formation of their pain experiences. This education focuses on the role of the central nervous system in pain by raising awareness about the neurobiology and neurophysiology of pain. It focuses on remodelling the behavioral approach to pain perception rather than anatomical damage. This approach aims to reduce patients' fear and catastrophizing by helping them better understand pain. Various metaphors, examples, and visuals are used during PNE to help patients understand pain mechanisms. PNE is thought to have an impact not only on pain but also on disability, functionality, and quality of life. PNE has been documented to have a positive effect not only on pain but also on other important factors such as disability, functionality, and quality of life.

A clinical study has shown that adding PNE to a telerehabilitation program has some positive effects, such as a reduction in symptom severity in patients with carpal tunnel syndrome. However, the number of studies in the literature on the efficacy of PNE in carpal tunnel syndrome is limited to a single study and is based on subjective methods such as patient statements. Unlike the previous study, this study will use objective and innovative assessment methods such as ultrasonography, quantitative sensory test and examination to evaluate symptoms and function.

The evaluation methods used in the study will enable a more in-depth and reliable analysis of symptom management and recovery processes, thereby facilitating the collection of more accurate and reliable data. As there are no similar studies using objective evaluation methods, the methodological contributions of this study will be highly valuable. By offering an innovative approach to pain management and rehabilitation through conservative treatment, it will make significant contributions to both scientific literature and clinical practice.

Being tested
Exercise, Pain neuroscience education
Keywords
Median Neuropathy, Mononeuropathies, Nerve Compression Syndromes, Education, Exercise, Pain neuroscience education, Carpal tunnel syndrome, Median nerve gliding exercise
Medical subject headings
Carpal Tunnel Syndrome, Median Neuropathy, Mononeuropathies, Nerve Compression Syndromes, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    Also called Median nerve gliding exercises, Self-stretching of carpal ligament

    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 educationBehavioural

    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.

Study groups in NCT07302282
Study groupRoleWhat they receive
Group 1 (home based exercise program)Active comparatorGroup 1 will receive training on median nerve gliding exercises and self-stretching exercises for the carpal ligament. Patients will be asked to perform 3 sets of median nerve gliding exercises, each consisting of 10 repetitions, and self-stretching exercises for the carpal ligament 3 times a day for 30 seconds as part of home program.
Receives: Other: Exercise
Group 2 (home based exercise program and pain neuroscience education)ExperimentalGroup 2 will receive exercise and pain neuroscience education. The exercise will be taught as a home program, similar to the other group. Pain neuroscience training will be provided twice a week for a total of 6 sessions by a trained physical therapist.
Receives: Other: Exercise; Behavioral: Pain neuroscience education

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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").

    Measured: 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%.

    Measured: Baseline, in the 3rd week and in the 6th week

  5. Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)

    It consists of a total of 7 items. The scale is scored between 0 and 24, with a score of 12 or higher suggesting neuropathic pain.

    Measured: Baseline, in the 3rd week and in the 6th week

Secondary outcomes (6)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline, in the 3rd week and in the 6th week

  5. Hand grip strength measurement

    The Baseline® hydraulic hand dynamometer-90 kg (Fabrication Enterprises, White Plains, New York 10602, USA) will be used for hand grip strength measurements. According to the test procedure, three measurements will be taken for hand grip and finger grip strength, with one-minute intervals between each measurement, and the average peak force value will be recorded in kilograms.

    Measured: Baseline, in the 3rd week and in the 6th week

  6. Finger pinch strength measurement

    The Baseline® hydraulic pinchmeter (Fabrication Enterprises, USA) will be used for pinch force measurements. According to the test procedure, three measurements will be taken for hand grip and finger grip strength, with one-minute intervals between each measurement, and the average peak force value will be recorded in kilograms.

    Measured: Baseline, in the 3rd week and in the 6th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2025
  2. Study start29 Dec 2025
  3. Primary completion31 Jul 2026
  4. Study completion31 Jul 2026

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
After being diagnosed with mild to moderate CTS based on electrophysiological findings, patients will be randomly assigned to two groups. One group (Group 1) will receive home based exercise program, while the other group (Group 2) will receive home based exercise program and pain neuroscience education.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07302282
Sponsor's protocol ID
25-2025/12
Status last verified
Dec 2025
First submitted
28 Nov 2025
Last updated
5 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Exercise and Pain neuroscience education in people with Carpal Tunnel Syndrome (CTS), run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).

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 3 inclusion and 11 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: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (time frame: Baseline, in the 3rd week and in the 6th week). The study lists 5 primary outcomes in all. 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 5 Aug 2026.

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