- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07410819
Investigation of the Effectiveness of Cervicothoracic Exercises in Individuals With Carpal Tunnel Syndrome
Karpal Tünel Sendromu Olan Bireylerde Servikotorakal Egzersizlerin Etkinliğinin Araştırılması
This randomized, parallel-group controlled clinical trial aims to investigate the effects of adding cervicothoracic exercises to conventional physiotherapy on pain, functional status, grip strength, and range of motion in individuals with carpal tunnel syndrome (CTS). CTS is a common compressive neuropathy of the median nerve, characterized by pain, numbness, tingling, nocturnal symptoms, and reduced hand function. Sixty adults diagnosed with CTS will be randomly allocated into two groups (n=30 each): a conventional physiotherapy group and a cervicothoracic exercise plus conventional physiotherapy group.
The conventional physiotherapy program includes transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, median nerve mobilization, wrist range-of-motion exercises, and strengthening exercises. The intervention group will receive the same conventional physiotherapy program in addition to cervicothoracic exercises targeting cervical mobility, scapular stabilization, and thoracic spine mobility. The intervention will be applied five days per week for six weeks.
Outcome measures will be assessed at baseline and at the end of week 6. Primary outcomes include pain intensity measured by the Visual Analog Scale (VAS), functional status assessed using the Boston Carpal Tunnel Questionnaire (BCTQ), and grip strength measured with a Jamar hand dynamometer. Secondary outcomes include upper extremity function evaluated using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and wrist and finger range of motion measured with a goniometer. Data will be analyzed using appropriate statistical methods, with statistical significance set at p<0.05. This study aims to determine whether adding cervicothoracic exercises to conventional physiotherapy provides additional clinical benefits in CTS rehabilitation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zehranur Kaya, MSc Student
- Phone Number: +90 +905346240476
- Email: zehrakayax@icloud.com
Study Locations
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-
Pendik
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Istanbul, Pendik, Turkey (Türkiye), 340003,4000
- Recruiting
- Istanbul Medipol University Pendik Hospital
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Istanbul, Pendik, Turkey (Türkiye), 34000
- Recruiting
- Istanbul Medipol University & Istanbul Medipol University Pendik Hospital
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Contact:
- Zehranur Kaya, MSc Student
- Phone Number: +90 +905346240476
- Email: zehrakayax@icloud.com
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Principal Investigator:
- Zehranur Kaya, MSc Student
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age over 18
- Symptom duration of at least 12 weeks,
- Information about carpal tunnel syndrome received from a physician,
- Positive Tinel or Phalen test in carpal compression test,
- Pain intensity, Visual Analog Scale, at least 40 mm out of 100 mm
Exclusion Criteria:
- Any sensory or motor deficit in the ulnar or radial nerve
- History of previous surgery or injection in the wrist
- Trauma to the neck, shoulder, or upper extremity
- Pregnancy
- Concurrent cervical radiculopathy or polyneuropathy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm 1 - Conventional Physiotherapy (Control)
Participants will receive conventional physiotherapy including transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, median nerve mobilization, wrist range-of-motion exercises, and strengthening exercises, five days per week for six weeks
|
Participants will receive a conventional physiotherapy program consisting of transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, median nerve mobilization, wrist range-of-motion exercises, and hand strengthening exercises.
TENS will be applied using sensory-level stimulation without muscle contraction.
Therapeutic ultrasound will be delivered over the carpal tunnel region using standard clinical parameters.
Median nerve mobilization and wrist exercises will be performed under physiotherapist supervision.
The treatment will be administered five days per week for six weeks.
Other Names:
|
|
Experimental: Arm 2 - Cervicothoracic Exercises + Conventional Physiotherapy
Participants will receive cervicothoracic exercises in addition to conventional physiotherapy.
Cervicothoracic exercises will target cervical mobility, scapular stabilization, and thoracic spine mobility.
Treatment will be applied five days per week for six weeks.
|
Participants will receive cervicothoracic exercises in addition to the same conventional physiotherapy program.
The cervicothoracic exercise program will include cervical mobility exercises, scapular stabilization, and thoracic spine mobility exercises designed to improve proximal neural mechanics and upper limb function.
All interventions will be supervised by a physiotherapist and applied five days per week for six weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Boston Carpal Tunnel Syndrome Questionnaire
Time Frame: Assessment will be taken initially and after the intervention (for 6 weeks, 5 days a week).
|
This questionnaire will be used to measure hand and wrist symptom and function scores in carpal tunnel syndrome.
The scale consists of two sub-sections: Symptom Severity and Functional Status.
The Symptom Severity Scale evaluates symptoms such as pain, numbness, tingling, and nighttime awakenings, while the Functional Status Scale measures difficulties in daily living activities such as writing, grasping, and carrying objects.
Each item is scored between 1 (no complaints) and 5 (very severe complaints); higher scores indicate more symptoms and functional limitations.
|
Assessment will be taken initially and after the intervention (for 6 weeks, 5 days a week).
|
|
Visual Analog Scale
Time Frame: Assessment will be taken initially and after the intervention (for 6 weeks, 5 days a week).
|
The Visual Analog Scale will be used to assess pain.
The Visual Analog Scale is a measurement tool that allows individuals to subjectively assess the intensity of their pain, defined by endpoints of "0 = no pain" and "10 = unbearable pain" on a 10 cm long horizontal line.
Participants are asked to mark the point on this line that corresponds to the intensity of the pain they feel.
A higher score indicates more severe pain.
|
Assessment will be taken initially and after the intervention (for 6 weeks, 5 days a week).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disabilities of the Arm Shoulder and Hand (DASH)
Time Frame: Assessment will be taken initially and after the intervention (for 6 weeks, 5 days a week).
|
The questionnaire will be used to assess the upper extremity function of the participants. The questionnaire consists of a 30-item scale, and each item is scored between 1 (no difficulty) and 5 (very great difficulty). The total score is converted into a score between 0 and 100; higher scores indicate more functional limitations and symptoms. |
Assessment will be taken initially and after the intervention (for 6 weeks, 5 days a week).
|
|
Jamar Hydraulic Hand Dynamometer (Hand Grip Strength)
Time Frame: Assessment will be taken initially and after the intervention (for 6 weeks, 5 days a week).
|
Hand grip strength will be measured using a Jamar hydraulic hand dynamometer.
Procedure: The patient will be seated upright, with shoulders in a natural position and adduction, and elbows at 90° flexion, when the measurement will be taken with the Jamar dynamometer.
Three repetitions will be performed for the measurement, and the average will be taken.
|
Assessment will be taken initially and after the intervention (for 6 weeks, 5 days a week).
|
|
Goniometer (Wrist Range of Motion)
Time Frame: Assessment will be taken initially and after the intervention (for 6 weeks, 5 days a week).
|
Wrist joint range of motion (ROM) will be measured with a goniometer, assessing flexion, extension, ulnar deviation, and radial deviation.
The participant will be seated with the forearm pronated and supported on a table.
For flexion and extension, the pivot will be placed on the ulnar styloid process, the fixed arm aligned with the ulna, and the movable arm along the 5th metacarpal.
For ulnar and radial deviation, the pivot will be positioned proximal to the third metacarpal, the fixed arm aligned with the forearm, and the movable arm parallel to the third metacarpal.
The fixed arm will remain stationary, each movement will be measured three times, and the average value will be used for analysis.
|
Assessment will be taken initially and after the intervention (for 6 weeks, 5 days a week).
|
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
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
- Behavior
- Carpal Tunnel Syndrome
- Motor Activity
- Therapeutics
- Rehabilitation
- Physical Therapy Modalities
- Conservative Treatment
Other Study ID Numbers
- IMU-FTR-ZK-01
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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