Magnetotherapy in Carpal Tunnel Syndrome: Randomized Controlled Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFatih Sultan Mehmet Training and Research Hospital
About this trial
This study is designed to investigate the effectiveness of low-frequency pulsed electromagnetic field therapy in individuals diagnosed with mild-to-moderate carpal tunnel syndrome (CTS). This double-blind, randomized controlled trial will randomly assign participants into three groups:
Group 1: Active magnetotherapy
Group 2: Placebo magnetotherapy (treatment using an identical device that does not generate a magnetic field)
Group 3: Routine (conservative) treatment group
All participants will receive a standard nighttime wrist splint and a standardized nerve and tendon gliding exercise protocol. Magnetic field applications will be administered five days per week for a total of 15 sessions. Assessments will be conducted at baseline (T0), at the end of treatment (T1 - Week 3), at 1 month (T2), and at 3 months (T3).
The primary outcome measures include the Boston Carpal Tunnel Questionnaire (BCTQ), pain intensity assessed by the Visual Analog Scale (VAS), functional status measured by QuickDASH, median nerve cross-sectional area assessed by ultrasonography, sensory function evaluated using the Semmes-Weinstein monofilament test, grip strength measured by dynamometry, and clinical test results (Tinel and Phalen tests). Secondary outcomes include sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI) and patient satisfaction.
This study aims to contribute to the scientific evidence regarding the effectiveness of magnetotherapy as a non-invasive treatment option for carpal tunnel syndrome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged between 18 and 65 years.
Disqualifiers
Severe carpal tunnel syndrome confirmed electrophysiologically by electromyography (EMG).
Trial design
Design model
Parallel
Treatments tested in this trial
Arm 1: Active Magnetotherapy Group
DeviceParticipants assigned to this group will receive active pulsed electromagnetic field (PEMF) therapy administered five days per week for three consecutive weeks, totaling 15 treatment sessions. Each session will last 15-20 minutes. The treatment will be delivered using a clinically approved medical device set at a frequency of 50 Hz and a magnetic field intensity of 2-3 millitesla (mT). The application will be performed in a controlled clinical setting by trained healthcare personnel. In addition to magnetotherapy, all participants in this group will receive standard conservative treatment, including the use of a neutral-position wrist splint during nighttime and a standardized home-based exercise program consisting of nerve gliding and tendon gliding exercises. Participants will be instructed on proper exercise performance and adherence will be monitored throughout the study period.
Arm 2: Sham (Placebo) Magnetotherapy Group
DeviceParticipants in this group will undergo a sham magnetotherapy procedure using the same device, with identical appearance, positioning, session duration, and application protocol as the active treatment group. However, the device will be set to a mode that does not generate a magnetic field. This approach is designed to maintain participant blinding and control for placebo effects. Similar to the active group, participants will receive standard conservative treatment consisting of nighttime wrist splint use and the same standardized nerve and tendon gliding home exercise program. Exercise instructions and compliance monitoring will be identical to those of the active treatment group.
Arm 3: Conservative Treatment (Wait-List Control) Group
Other interventionParticipants in this group will receive standard conservative management only, including nighttime wrist splinting and the standardized home-based nerve and tendon gliding exercise program. No magnetotherapy device will be applied during the study period. To ensure ethical considerations, participants in this group will be placed on a wait-list and may be offered magnetotherapy after completion of the follow-up assessments. Compliance with splint use and exercise performance will be monitored similarly to the other groups.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Group 1 (Magnetotherapy Group):Active comparator 1 intervention
Group B: Group 2 (Placebo Magnetotherapy Group)Sham comparator 1 intervention
Group C: Group 3 (Routine/Conservative Treatment Group)Other 1 intervention
Trial outcomes
Primary outcomes
1
Symptom Severity Assessed by Boston Carpal Tunnel Questionnaire Symptom Severity Scale
The Boston Carpal Tunnel Questionnaire Symptom Severity Scale is an 11-item patient-reported outcome measure assessing the severity and frequency of carpal tunnel syndrome symptoms. Each item is scored from 1 (no symptoms) to 5 (most severe symptoms). The final score is calculated as the mean of all items, ranging from 1 to 5. Higher scores indicate more severe symptoms and worse clinical outcome.
Time frame
Baseline (Week 0), Week 3, Month 1, Month 32
Wrist Pain Intensity Assessed by Visual Analog Scale
Pain intensity will be measured using a 10-centimeter Visual Analog Scale. The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores indicate greater pain severity and worse outcome.
Time frame
Baseline (Week 0), Week 3, Month 1, Month 33
Upper Extremity Function Assessed by Quick Disabilities of the Arm, Shoulder and Hand Questionnaire
Upper extremity function will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire. This 11-item validated questionnaire is scored on a 5-point Likert scale and transformed to a total score ranging from 0 to 100. A score of 0 represents no disability and 100 represents maximum disability. Higher scores indicate worse functional impairment.
Time frame
Baseline (Week 0), Week 3, Month 1, Month 34
Hand Grip Strength Assessed by Jamar Dynamometer
Hand grip strength will be measured using a calibrated Jamar dynamometer and recorded in kilograms (kg). Higher values indicate greater muscle strength and better functional outcome.
Time frame
Baseline (Week 0), Week 3, Month 1, Month 3Secondary outcomes
1
Sleep Quality Assessed by Pittsburgh Sleep Quality Index
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. The total global score ranges from 0 to 21. Higher scores indicate poorer sleep quality and worse outcome.
Time frame
Baseline (Week 0), Week 3, Month 1, Month 32
Patient Satisfaction Assessed by 5-Point Likert Scale
Patient satisfaction will be assessed using a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction and better perceived treatment outcome.
Time frame
Week 3 (End of Treatment)Sponsors and contacts
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Source ClinicalTrials.gov
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