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

NCT ID: NCT07302282

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-08-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carpal Tunnel Syndrome (CTS)

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1 (home based exercise program)

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.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type 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.

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

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.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type 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.

Pain neuroscience education

Intervention Type OTHER

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.

Interventions

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Exercise

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.

Intervention Type OTHER

Pain neuroscience education

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.

Intervention Type OTHER

Other Intervention Names

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Median nerve gliding exercises Self-stretching of carpal ligament

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karaman Training and Research Hospital

OTHER

Sponsor Role collaborator

Karamanoğlu Mehmetbey University

OTHER

Sponsor Role lead

Responsible Party

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MAHMUT TALHA SUSAM

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmut Talha Susam, MD

Role: STUDY_CHAIR

Karamanoglu Mehmetbey University Physical Medicine and Rehabilitation

Mahmut Talha Susam, MD

Role: PRINCIPAL_INVESTIGATOR

Karamanoglu Mehmetbey University Physical Medicine and Rehabilitation

Aynur Başaran, Prof.MD

Role: PRINCIPAL_INVESTIGATOR

Karamanoglu Mehmetbey University Physical Medicine and Rehabilitation

Süleyman Gül, PhD

Role: PRINCIPAL_INVESTIGATOR

Karamanoglu Mehmetbey University Physical Medicine and Rehabilitation

Elif Dilara Durmaz, Pt

Role: PRINCIPAL_INVESTIGATOR

Karaman Training and Research Hospital

Locations

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Karaman Training and Research Hospital

Karaman, Karaman, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Mahmut Talha Susam, MD.

Role: CONTACT

Phone: 5458445753

Email: [email protected]

Facility Contacts

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Mahmut Talha Susam, MD

Role: primary

Other Identifiers

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25-2025/12

Identifier Type: -

Identifier Source: org_study_id