- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06882707
The Effectiveness of Neurodynamic Mobilization in Carpal Tunnel Syndrome
The Effectiveness of Neurodynamic Nerve Mobilization in Addition to Physical Therapy on the Median Nerve and Abductor Pollicis Brevis Muscle in Patients With Mild and Moderate Carpal Tunnel Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Turkey
-
Kütahya, Turkey, Turkey (Türkiye), 43050
- Kutahya Health Sciences University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with mild-to-moderate CTS on the dominant hand, based on the electrodiagnostic examination.
- Aged 20-55 years.
- Consent to receive the described treatment.
- Lasting symptoms at least 3 months
Exclusion Criteria:
- A systemic inflammatory disease.
- Any disease that can cause polyneuropathy, for example, diabetes mellitus.
- A cognitive disorder.
- Receiving psychotherapy.
- A pacemaker.
- Any disease that can affect the central nervous system.
- Carpal tunnel syndrome surgery history
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Median nerve mobilization in addition to ultrasound therapy
In addition nerve mobilization, ultrasound therapy will be applied to all patient in experimental group via methods explained below.
|
Passive neuromobilisation of the median nerve and functional self-exercises. The procedure started with the patient in the supine position. The following steps were taken in sequence: shoulder girdle depression; slight abduction of the elbow extension with arm lateral rotation and forearm supination; wrist, finger and thumb extensions were added; and the shoulder was taken into further extension. To apply maximum stretch opposite cervical side flexion was done, and, in the end, the wrist was repeatedly moved into and out of stretch by performing a few degrees of flexion and extension at the wrist. This mobilization technique will be performed by an experienced physician/physiotherapist three times a week for 3 weeks, and the patients will be given 3 sets of 15 cycles with a 1-minute rest period in each set.
In control group, patients will received only ultrasound therapy.
The patient will be in a sitting position with his/her face facing the physiotherapy technician, elbow in 90 degree flexion, forearm in supination, wrist in neutral position and supported by placing a towel under the patient's extremity and will be applied in Us intermittent mode with an intensity of 0.8 W/cm2 in 1 MHZ frequency in 1:4 mode for 10 minutes, moving in a way to draw an infinity sign for 10 seconds.
Treatment will be given 5 days a week for 3 weeks and a total of 15 sessions.
|
|
Active Comparator: Ultrasound therapy
In control group, patients will received only ultrasound therapy.
|
In control group, patients will received only ultrasound therapy.
The patient will be in a sitting position with his/her face facing the physiotherapy technician, elbow in 90 degree flexion, forearm in supination, wrist in neutral position and supported by placing a towel under the patient's extremity and will be applied in Us intermittent mode with an intensity of 0.8 W/cm2 in 1 MHZ frequency in 1:4 mode for 10 minutes, moving in a way to draw an infinity sign for 10 seconds.
Treatment will be given 5 days a week for 3 weeks and a total of 15 sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ultrasound assessment
Time Frame: Change from Baseline at 3th weeks
|
The Median nerve's diameter will be evaluated bilaterally by another researcher blinded to interventions and experienced in musculoskeletal ultrasonography, using ultrasound with a 6-18 Mhz linear probe (Mindray-UMT 200, USA). During the examination, patients will be seated on a stretcher, while the examiner sat on a higher stool. The Median nerve will be evaluated by measuring the circumference of the nerve at the location where the nerve entered the carpal tunnel. The ultrasound probe will be positioned above the epicondylus lateralis. The nerve cross-sectional area (CSA) will be recorded in the carpal tunnel while it was perpendicular to the wrist at 90 degrees on the Median nerve trace. The nerve diameter will be measured from the circumference of the epineurium. |
Change from Baseline at 3th weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand and pinching grip measurement
Time Frame: Change from Baseline at 3th weeks
|
The grip strength of the hand is measured with the Jamar hand dynamometer recommended by the American Association of Hand Therapists (AETD). The measurement will be performed in the standard position specified by the AETD; the patient will be seated, shoulders in adduction and neutral rotation, elbow in 90 degree flexion, forearm in mid-rotation and supported, wrist in neutral position with three repetitions and the results will be recorded in kilograms. Pinch force will be measured in the same position as the hand grip strength is measured with a pincmeter. It will be evaluated in two different positions, lateral and triple grip. When evaluating the lateral grip, the patient will be asked to press the pinchmeter from the top with the middle of the distal phalanx of the thumb and support the lower part of the pinchmeter with the second phalanx of the index finger. When evaluating the triple grip, measurements will be made by squeezing the thumb on one side of the pinchmeter an |
Change from Baseline at 3th weeks
|
|
Symptom severity and functional status
Time Frame: Change from Baseline at 3th weeks
|
Symptom severity and functional status were evaluated with BCTQ, a self-report measure of CTS with two domains: the Boston Carpal Tunnel Syndrome Questionnaire Symptom severity scale comprising 11 items to evaluate pain, paresthesia, and weakness and the Boston Carpal Tunnel Syndrome Questionnaire Symptom functional status domain with eight items assessing the ability to perform hand-related activities. For each item, a high score indicates an increasing severity of symptoms or difficulty experienced. The validity and reliability analyses of the Turkish version of BCTQ were undertaken by Sezgin et al19 Reliability of the Turkish version was very good, with high internal consistency (Cronbach's alpha 0.82 for symptom severity scale, and 0.88 for functional status scale), and reproducibility (Pearson correlation coefficient 0.60 for symptom severity scale, and 0.77 for functional status scale). |
Change from Baseline at 3th weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Merve Akdeniz Leblebicier, MD, Kutahya Health Sciences University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- MedianNerveMobilization
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
product manufactured in and exported from the U.S.
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)
-
Galala UniversityCompletedCarpal Tunnel Syndrome (CTS)Egypt
-
Stanford UniversityCompletedCarpal Tunnel Syndrome (CTS)United States
-
Fundacin Biomedica Galicia SurCompletedCarpal Tunnel Syndrome (CTS)Spain
-
GCS Ramsay Santé pour l'Enseignement et la RechercheCompletedCarpal Tunnel Syndrome (CTS) | Heel Pain SyndromeFrance
-
Ankara UniversityNot yet recruitingCarpal Tunnel Syndrome (CTS)Turkey (Türkiye)
-
Afyonkarahisar Health Sciences UniversityRecruitingCarpal Tunnel Syndrome (CTS)Turkey (Türkiye)
-
Assiut UniversityNot yet recruiting
-
Sohag UniversityNot yet recruitingCarpal Tunnel Syndrome (CTS)Egypt
-
ElsanRecruiting
-
Benha UniversityCompletedSimultaneous vs. Postponed Carpal Tunnel Release (CTR) During Distal Radius Fracture (DRF) Fixation.Carpal Tunnel Syndrome (CTS)Egypt
Clinical Trials on Median Nerve Mobilization
-
Universidad Europea de MadridCompletedCervicobrachial NeuralgiaVenezuela
-
Universidad Europea de MadridCompleted
-
Izmir Katip Celebi UniversitySuspendedLateral EpicondylitisTurkey (Türkiye)
-
University of FloridaNational Center for Complementary and Integrative Health (NCCIH)CompletedCarpal Tunnel SyndromeUnited States
-
Washington University School of MedicineNational Center for Advancing Translational Sciences (NCATS)CompletedTourette Syndrome | Tic Disorders | Tic Disorder, Chronic Motor or VocalUnited States
-
Hopital FochCompleted
-
Galala UniversityCompletedCarpal Tunnel Syndrome (CTS)Egypt
-
Hospital Universitario 12 de OctubreFundación para la Investigación Biomédica Hospital Universitario 12 de OctubreCompletedAcute Distal Radius Fracture | Displaced Distal Radius FractureSpain