- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07359274
Effects of Neurodynamic and Carpal Bone Mobilization in Mild-to-Moderate Carpal Tunnel Syndrome
Clinical and Morphological Effects of Neurodynamic Mobilization and Carpal Bone Mobilization Techniques in Patients With Mild-to-Moderate Carpal Tunnel Syndrome
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy caused by compression of the median nerve at the wrist. Conservative interventions such as splinting and manual therapy are frequently used in individuals with mild-to-moderate CTS. Neurodynamic mobilization and carpal bone mobilization aim to improve neural and soft tissue mobility; however, their comparative effects on clinical outcomes and median nerve morphology are not fully understood.
This interventional, non-randomized clinical study aims to compare the clinical and ultrasonographic effects of neurodynamic mobilization plus splinting, carpal bone mobilization plus splinting, and splinting alone in patients with mild-to-moderate CTS. Ninety-three participants diagnosed with mild-to-moderate carpal tunnel syndrome based on electrodiagnostic criteria will be included. Participants will be allocated into three parallel groups without randomization. All participants will receive a neutral-position wrist splint as standard conservative care.
Two intervention groups will additionally receive either neurodynamic mobilization exercises or carpal bone mobilization techniques administered by a physiotherapist for four weeks. Clinical outcomes and median nerve morphology will be evaluated at baseline and immediately after the intervention period.
The primary outcome is the change in the Boston Carpal Tunnel Questionnaire score. Secondary outcomes include pain intensity, neuropathic pain, functional disability, muscle strength, pressure pain threshold, and ultrasonographic measurements of the median nerve.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Merve Akdeniz Leblebicier, MD
- Phone Number: 4343 00902742600043
- Email: merve1985akdeniz@hotmail.com
Study Contact Backup
- Name: Esengül Alıcı, MD
- Phone Number: 4343 00902742600043
- Email: essengulalici@gmail.com
Study Locations
-
-
Yoncalı
-
Kütahya, Yoncalı, Turkey (Türkiye), 43000
- Kutahya Health Sciences University Yoncalı Physical Therapy and Rehabilitation Hospital
-
Contact:
- Merve Akdeniz Leblebicier, MD
- Phone Number: 4343 00902742600043
- Email: merve1985akdeniz@hotmail.com
-
Contact:
- Esengül Alıcı, MD
- Phone Number: 4343 00902742600043
- Email: essengulalici@gmail.com
-
Principal Investigator:
- Esengul Alıcı, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of mild-to-moderate carpal tunnel syndrome confirmed by electrodiagnostic testing
- CTS symptoms for at least 3 months
- Ability to provide informed consent
Exclusion Criteria:
- Previous carpal tunnel surgery
- Diabetes mellitus or polyneuropathy
- Cervical radiculopathy
- Pregnancy or breastfeeding
- Central nervous system disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: neurodynamic mobs in addition splint
Median nerve neurodynamic mobilization exercises administered by a physiotherapist for 4 weeks in addition to night-time wrist splint use
|
Median nerve neurodynamic mobilization exercises performed 5 sessions per week for 4 weeks.
Neutral-position wrist splint used during night-time for 4 weeks.
|
|
Experimental: Carpal Bone Mobilization + Splint
Carpal bone mobilization techniques administered by a physiotherapist for 4 weeks in addition to night-time wrist splint use.
|
Neutral-position wrist splint used during night-time for 4 weeks.
Manual carpal bone mobilization techniques applied 5 sessions per week for 4 weeks.
|
|
Active Comparator: Splint only
Neutral-position wrist splint worn at night for 4 weeks.
|
Neutral-position wrist splint used during night-time for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Boston Carpal Tunnel Questionnaire (BCTQ) Total Score
Time Frame: Baseline to 4 weeks
|
Change in Boston Carpal Tunnel Questionnaire (BCTQ) Total Score
|
Baseline to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: Baseline to 4 weeks
|
Pain intensity measured using a 10-cm visual analog scale.
|
Baseline to 4 weeks
|
|
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
Time Frame: Baseline to 4 weeks
|
Change in Neuropathic Pain Score Assessed by Leeds Assessment of Neuropathic Symptoms and Signs (LANSS).
|
Baseline to 4 weeks
|
|
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Time Frame: Baseline to 4 weeks
|
Change in Upper Extremity Disability Assessed by Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH).
|
Baseline to 4 weeks
|
|
Grip Strength
Time Frame: Baseline to 4 weeks
|
Change Grip strength measured using a Jamar dynamometer.
|
Baseline to 4 weeks
|
|
Pinch Strength
Time Frame: Baseline to 4 weeks
|
Change in Pinch Strength measured using a Pinchmeter.
|
Baseline to 4 weeks
|
|
Pressure Pain Threshold
Time Frame: Baseline to 4 weeks
|
Change in pressure pain threshold assessed using J -Tech algometer.
|
Baseline to 4 weeks
|
|
Median Nerve Cross-Sectional Area
Time Frame: Baseline to 4 weeks
|
Change in Median Nerve Cross-Sectional Area Assessed by Ultrasonography.
|
Baseline to 4 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Merve Akdeniz Leblebicier, MD, Kütahya Health Sciences University
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
- Nervous System Diseases
- Wounds and Injuries
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Median Neuropathy
- Mononeuropathies
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Carpal Tunnel Syndrome
- External Fixators
- Orthopedic Fixation Devices
- Orthopedic Equipment
- Surgical Equipment
- Equipment and Supplies
- Surgical Fixation Devices
- Splints
Other Study ID Numbers
- Neurodynamic and Carpal Mobs
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.
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