- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07539480
Pain Neuroscience Education Versus Kinesio Tape on Functional Outcomes in Patients With Carpal Tunnel Syndrome (CP syndrome)
Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) is one of the most common compressive neuropathies of the upper limb, characterized by pain, numbness, and functional impairment due to median nerve compression at the wrist. Its prevalence is estimated at approximately 4.9%, with higher incidence in populations exposed to repetitive hand movements. The resulting sensory disturbances, grip weakness, and functional limitations significantly affect daily activities and quality of life.
Conservative management remains the first line of treatment for mild to moderate CTS, with therapeutic approaches traditionally including splinting, exercise therapy, nerve mobilization, and patient education. Recent interest has grown around Pain Neuroscience Education (PNE)-an educational strategy that reframes patients' understanding of pain by emphasizing the role of the central nervous system, cognitive factors, and neurophysiological processes. Studies have shown that PNE, particularly when combined with exercise or standard rehabilitation, can reduce symptom severity, improve functional outcomes, and help patients better manage chronic pain by reducing fear and catastrophizing. However, the existing literature notes that research on PNE for CTS is still limited, with some trials suggesting positive outcomes but calling for more high-quality evidence.
In parallel, Kinesio Taping (KT) has gained popularity as a noninvasive intervention believed to enhance circulation, provide proprioceptive input, and support soft tissue mobility. Evidence from randomized controlled trials shows that KT can improve grip strength, reduce pain intensity, enhance sensory conduction velocity, and improve functional status as measured by validated clinical tools such as the Boston Carpal Tunnel Questionnaire. These findings suggest that KT may serve as an effective supplementary therapy in the conservative management of CTS
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Giza Governorate
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October City, Giza Governorate, Egypt, 6892
- Bassam Ahmed Nabil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged 18 to 60 years.
- Clinically diagnosed unilateral or bilateral carpal tunnel syndrome based on standard diagnostic criteria (e.g., pain, numbness, or tingling in the median nerve distribution), with or without confirmation by nerve conduction studies.
- Patients with mild to moderate carpal tunnel syndrome, defined by clinical assessment and electrodiagnostic findings.
- Symptoms present for at least 3 months.
- Reported wrist or hand pain with functional limitations affecting daily activities.
Exclusion Criteria:
- Severe CTS characterised by significant thenar muscle atrophy or severe nerve conduction impairment.
- Previous Surgery or Injection:
- History of carpal tunnel release surgery or corticosteroid injection to the wrist within the past 6 months.
- Presence of other conditions affecting the upper limb, such as cervical radiculopathy, peripheral neuropathy, rheumatoid arthritis, tendon rupture, or fractures.
- Known neurological disorders (e.g., stroke, multiple sclerosis) or systemic diseases affecting nerve function (e.g., uncontrolled diabetes mellitus).
- Skin disease, open wounds, or known allergy to adhesive materials that contraindicate kinesio taping.
- Pregnant women, due to possible changes in fluid retention and nerve compression.
- Participation in other physical therapy or pain education programmes targeting the upper limbs during the study period.
- Conditions that limit comprehension of pain neuroscience education material or ability to provide reliable responses to questionnaires.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group A: pain neuroscience education (PNE)
PNE Components
|
1- Education on neurobiology and neurophysiology of pain 2- How beliefs and behaviours influence pain 3- Central sensitization and pain amplification 4- Use of metaphors, visuals, and interactive discussion the frequency of the session 1- 1 session/week, 30-40 minutes 2- Duration: 6 weeks 3- Delivered by a trained physiotherapist
|
|
Experimental: group B: Patients receive Kinesio Taping
KT Application Technique
|
KT Application Technique 1- Elastic tape placed along flexor retinaculum and median nerve pathway 2- Tension: 10-15% 3- Reapplied twice weekly 4- Duration: 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 8 weeks
|
self-reported pain intensity scale ranging from 0 (no pain) to 10 (worst imaginable pain), assessing average hand pain over the past week.
|
8 weeks
|
|
Boston Carpal Tunnel Questionnaire
Time Frame: 8 months
|
The BCTQ is a tool that assesses difficulty in performing daily activities of the hand such as writing, gripping and lifting objects It consists of eight items, each scored from 1 (no difficulty) to 5 (unable to perform activity). Higher scores indicate greater functional disability. |
8 months
|
|
Jamar Hand-Held Dynamometer (kg)
Time Frame: 8 months
|
Assess the maximum voluntary grip strength of the affected hand.
Three trials are recorded, and the mean value is used for analysis.
|
8 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2730
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carpal Tunnel Syndrome (CTS)
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Galala UniversityCompletedCarpal Tunnel Syndrome (CTS)Egypt
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Stanford UniversityCompletedCarpal Tunnel Syndrome (CTS)United States
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Fundacin Biomedica Galicia SurCompletedCarpal Tunnel Syndrome (CTS)Spain
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GCS Ramsay Santé pour l'Enseignement et la RechercheCompletedCarpal Tunnel Syndrome (CTS) | Heel Pain SyndromeFrance
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Ankara UniversityNot yet recruitingCarpal Tunnel Syndrome (CTS)Turkey (Türkiye)
-
Afyonkarahisar Health Sciences UniversityRecruitingCarpal Tunnel Syndrome (CTS)Turkey (Türkiye)
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Assiut UniversityNot yet recruiting
-
Sohag UniversityNot yet recruitingCarpal Tunnel Syndrome (CTS)Egypt
-
ElsanRecruiting
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Benha UniversityCompletedSimultaneous vs. Postponed Carpal Tunnel Release (CTR) During Distal Radius Fracture (DRF) Fixation.Carpal Tunnel Syndrome (CTS)Egypt
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