- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06554405
Bilateral vs. Unilateral Neuromobilization in Carpal Tunnel Syndrome
Examining the Effects of Bilateral Neuromobilization in Patients With Carpal Tunnel Syndrome: Comparison Study With Unilateral Application
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Carpal Tunnel Syndrome (CTS) is defined as an upper extremity nerve entrapment resulting from the compression of the median nerve at the wrist level. It is the most common entrapment neuropathy. Patients with CTS experience numbness, tingling, and pain in the hand, which can sometimes extend to the arm, along with hand weakness and thenar atrophy. These symptoms typically worsen after hand use and at night. While clinical findings are absent in the early stages of the disease, sensory and strength loss is observed in the areas innervated by the median nerve in advanced stages.
The pathophysiology of CTS includes hypertrophic changes in the synovial tissue of the flexor tendon, connective tissue changes in the median nerve, conduction disturbances, and increased pressure in the carpal tunnel.
Treatment is tailored to the patient's symptoms. Conservative treatment is preferred in mild to moderate stages, while surgical intervention may be necessary in advanced stages. All patients should receive education on ergonomics aimed at reducing symptoms in daily life.
Conservative treatment for CTS includes nerve mobilization techniques, the use of orthoses to maintain the wrist in a neutral position, electrotherapy (ESWT, laser), manual therapy, kinesiotaping, corticosteroid and platelet-rich plasma (PRP) injections, and anti-inflammatory medications. Patients who do not respond to conservative treatment are referred for surgery.
Neural structures are capable of tolerating significant tension and compression forces encountered during daily activities and sports. This capability is due to the connective tissue sheath surrounding the nerve.
The musculoskeletal system creates an environment that surrounds the nervous system, and its movements affect peripheral nerves. With the excursion (sliding) movement, compression on the peripheral nerve decreases. Clinical neuromobilization is a manual therapy method that integrates the mechanics and physiology of the nervous system with musculoskeletal function. Neuromobilization (NM) aims to balance the relationship between neural tissues and surrounding mechanical tissues, thereby regulating optimal physiological functions.
The aim of using neuromobilization exercises with sliding techniques in nerve entrapments is to increase axonal transport and improve nerve conduction. It has been suggested that these exercises can reduce pressure within the nerve, improve its blood supply, and thus contribute to nerve regeneration. Recent studies in the literature report that neuromobilization exercises have supportive effects in pain improvement, reduction of distal latency time, and increased pinch strength. A systematic review indicated these effects as pain improvement, lowering the pain threshold, improving function, and avoiding surgery. It was stated that neuromobilization exercises added to the CTS treatment program accelerate the rehabilitation process and enhance recovery.
Although there are studies in the literature proving the superiority of neuromobilization over other treatment methods, the number of studies investigating the application of neuromobilization to the unaffected side is limited. Considering that the connective tissue sheaths surrounding peripheral nerves in both upper extremities are connected via the central nervous system, it is hypothesized that neuromobilization applied to the unaffected side or bilaterally might be more effective on the symptomatic side compared to unilateral application. However, studies that consider this connection and include the unaffected side in treatment are significantly lacking.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara
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Ankara, Ankara, Turkey (Türkiye)
- Gazi University Faculty of Health Sciences
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals diagnosed with CTS,
- Aged 18 and above,
- Without any other conditions in either upper extremity (such as trigger finger, osteoarthritis, tenosynovitis)
Exclusion Criteria:
- Individuals with a history of surgery, trauma, or fracture in the same upper extremity,
- Those who have received an injection for CTS in the last 3 months,
- Those with poor cooperation,
- Those participating in any other treatment program during the study,
- Those with a history of uncontrolled systemic diseases or systemic diseases involved in the etiology of CTS (such as diabetes, thyroid diseases, rheumatoid arthritis),
- Those who have used orthoses regularly and/or received physiotherapy in the last 3 months,
- Individuals with marked thenar atrophy requiring early surgical intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Unilateral Intervention
Patients will be treated for 4 weeks (2 days in a week, 8 sessions).
The treatment plan involves massage therapy, neuromobilization exercises and cold application.
In this arm, treatment plan will be applied only for the symptomatic side.
The rest of the treatment will be the same as the other group.
|
Treatment plan will be applied to the symptomatic side.
|
|
Experimental: Bilateral Intervention
Patients will be treated for 4 weeks (2 days in a week, 8 sessions).
The treatment plan involves massage therapy, neuromobilization exercises and cold application.
In this arm, treatment plan will be applied only for both symptomatic and nonsymptomatic sides.
The rest of the treatment will be the same as the other group.
|
Treatment plan will be applied to the symptomatic and nonsymptomatic sides.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptom Severity Assessment (Boston Carpal Tunnel Syndrome Questionnaire- Symptom Severity Scale)
Time Frame: Four weeks
|
The Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ), developed in 1993, will be used to assess individuals' functional status and symptoms.
The Turkish validity and reliability study of the test has been conducted.
The test consists of two self-assessment sections: one with 11 questions evaluating symptom severity and another with 8 questions evaluating functional capacity.
It is a Likert-type questionnaire, where 1 indicates the best condition and 5 indicates the worst condition.
The total score is calculated by dividing the total points by the number of questions, resulting in a score between 1 and 5.
|
Four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: Four weeks
|
The Visual Analog Scale (VAS) will be used for pain assessment.
The individual will make a mark on a 10-centimeter horizontal line, where 0 indicates no pain and 10 indicates maximum pain.
This marking will be done separately for both rest and activity periods.
The data will be recorded in centimeters.
|
Four weeks
|
|
Light Touch and Pressure Sense
Time Frame: Four weeks
|
Light touch and pressure assessment will be performed using the Semmes-Weinstein Monofilament test.
This test kit contains five filaments ranging from 2.83 (0.07 grams of force) to 6.65 (300 grams of force).
These filaments are applied to the skin.
During the assessment, the individual should not see the filament.
First, the unaffected side is assessed, followed by the affected side.
During the evaluation, the filament is applied to the skin at a 90-degree angle and held for 1.5 seconds.
The application sites for the median nerve are the pulp of the first finger and the pulp of the second finger.
The patient is asked if they can feel the filament and should respond with "yes" or "no."
The evaluation starts with the lowest filament, 2.83, which represents normal sensation.
If the patient responds "yes," their sensation is recorded as normal.
If not, progressively higher-value filaments are used until a "yes" response is obtained.
|
Four weeks
|
|
Gross Grip Strength
Time Frame: Four weeks
|
For gross grip strength measurement, a hydraulic hand dynamometer (Baseline®, USA) will be used.
The measurement will be conducted in the standard position specified by the American Society of Hand Therapists.
In this position, the individual will sit on a chair with back support, with the elbow at 90 degrees of flexion and the wrist in a neutral position.
The person will be asked to squeeze the dynamometer with maximum force.
The measurement will be repeated three times, and the average will be recorded in kg/f.
|
Four weeks
|
|
Pinch Grip Strength
Time Frame: Four weeks
|
For pinch grip strength measurement, a mechanical pinch meter (Baseline®, USA) will be used.
Lateral (key) pinch, two-point (bipod, tip) pinch, and three-point (tripod, palmar) pinch measurements will be performed separately.
For the lateral pinch, the patient will be asked to squeeze the end of the pinch meter between the thumb and the lateral surface of the middle phalanx of the second finger with maximum force.
For the two-point pinch strength measurement, the patient will be asked to squeeze the pinch meter between the thumb and the pulp of the second finger, and for the three-point pinch strength measurement, between the thumb, the second finger, and the third finger as tightly as possible.
Assessments will be conducted bilaterally, starting with the healthy side.
The measurements will be repeated three times for each side, and the averages will be recorded in kg/f.
|
Four weeks
|
|
Functional Level Assessment (Boston Carpal Tunnel Syndrome Questionnaire-Functional Status Scale)
Time Frame: Four weeks
|
The Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ), developed in 1993, will be used to assess individuals' functional status and symptoms.
The Turkish validity and reliability study of the test has been conducted.
The test consists of two self-assessment sections: one with 11 questions evaluating symptom severity and another with 8 questions evaluating functional capacity.
It is a Likert-type questionnaire, where 1 indicates the best condition and 5 indicates the worst condition.
The total score is calculated by dividing the total points by the number of questions, resulting in a score between 1 and 5.
|
Four weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Öznur GÜNEY, Zonguldak Bülent Ecevit 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaziU-GUNEY-001
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.
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