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

NCT07302282 | Recruiting

• 1 other identifier: 25-2025/12
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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? 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.

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Education; Exercise; Pain neuroscience education; Carpal tunnel syndrome; Median nerve gliding exercise

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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.

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

• Numerical Rating Scale

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

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

• 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%.

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

• 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.

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

Secondary Outcomes (6)

• Ultrasound median nerve cross-sectional area

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

• Semmes-Weinstein Monofilament Test

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

• Two-Point Discrimination Test (2PD)

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

• Quantitative sensory evaluation

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

• Hand grip strength measurement

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

Study Arms (2)

Group 1 (home based exercise program)

ACTIVE COMPARATOR

Group 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.

Other: Exercise

Group 2 (home based exercise program and pain neuroscience education)

EXPERIMENTAL

Group 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.

Other: Exercise; Behavioral: Pain neuroscience education

Interventions

Exercise OTHER

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.

Also known as: Median nerve gliding exercises, Self-stretching of carpal ligament

Group 1 (home based exercise program); Group 2 (home based exercise program and pain neuroscience education)

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.

Group 2 (home based exercise program and pain neuroscience education)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead
• Karaman Training and Research Hospital: collaborator

Study Sites (1)

Karaman Training and Research Hospital

Karaman, Karaman, 70200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mahmut Talha Susam, MD

  Karamanoglu Mehmetbey University Physical Medicine and Rehabilitation

  STUDY CHAIR

• Mahmut Talha Susam, MD

  Karamanoglu Mehmetbey University Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Aynur Başaran, Prof.MD

  Karamanoglu Mehmetbey University Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Süleyman Gül, PhD

  Karamanoglu Mehmetbey University Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Elif Dilara Durmaz, Pt

  Karaman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmut Talha Susam, MD.

CONTACT

5458445753; mahmuttalhasusam@kmu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 24, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): August 17, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

TU (1)