Magnetotherapy in Carpal Tunnel Syndrome: Randomized Controlled Study
Evaluation of the Effectiveness of Magnetotherapy in Patients With Carpal Tunnel Syndrome: A Placebo-Controlled, Triple-Arm, Randomized, Double-Blind Study
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.
Study Overview
Status
Detailed Description
Carpal tunnel syndrome (CTS) is a common entrapment neuropathy caused by compression of the median nerve within the carpal tunnel at the wrist, resulting in symptoms such as tingling, numbness, pain, and functional impairment in the hand and fingers. According to the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM), the diagnosis is supported electrophysiologically by delayed distal motor or sensory conduction, conduction block, or prolonged response latency of the median nerve. Clinically, CTS presents with paresthesia, pain, numbness, and functional limitations. The condition is more prevalent among middle-aged individuals, particularly office workers, homemakers, and those engaged in repetitive wrist movements. If left untreated, CTS may lead to muscle weakness and a significant decline in quality of life.
Conservative treatment options include nighttime wrist splinting, nerve mobilization exercises, pharmacological therapy, and physical therapy modalities. However, these approaches are generally symptom-oriented and may have limited long-term effectiveness.
Magnetotherapy has emerged as a non-invasive physical therapy modality with minimal side effects. Pulsed electromagnetic field (PEMF) therapy has been reported to reduce pain and improve objective nerve function in refractory CTS cases in both short- and long-term follow-up. Nevertheless, scientific evidence regarding the effectiveness of magnetotherapy in CTS remains limited, and many existing studies lack robust methodological designs such as placebo control, randomization, and blinding. Therefore, this study aims to contribute to the current literature and strengthen clinical decision-making by providing high-quality evidence on the effectiveness of magnetotherapy in CTS.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pınar Akpınar, medical doctor
- Phone Number: +905057877442
- Email: pinar.pinarakpinar@gmail.com
Study Contact Backup
- Name: Orçun Ünalan, medical doctor
- Phone Number: +905337335856
- Email: orcununalan@gmail.com
Study Locations
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Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34734
- fatih sultan mehmet research and training hospital
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Contact:
- Orçun Ünalan, medical doctor
- Phone Number: +905337335856
- Email: orcununalan@gmail.com
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Principal Investigator:
- Orçun Ünalan, MD
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Sub-Investigator:
- Pınar Akpınar, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged between 18 and 65 years.
Clinical diagnosis of carpal tunnel syndrome (CTS) based on physical examination findings, including positive Tinel and/or Phalen tests and hypoesthesia in the 3rd to 5th digits.
Electrophysiologically confirmed mild-to-moderate carpal tunnel syndrome based on electromyography (EMG) findings.
Exclusion Criteria:
- Severe carpal tunnel syndrome confirmed electrophysiologically by electromyography (EMG).
History of previous surgical intervention for carpal tunnel syndrome.
Presence of other peripheral nerve entrapments (e.g., ulnar nerve entrapment, radial nerve entrapment).
Electrophysiologically confirmed polyneuropathy or cervical radiculopathy/cervical discopathy.
Rheumatologic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus).
Diabetes mellitus (Type 1 or Type 2).
Pregnancy.
Presence of electronic implants such as cardiac pacemaker, cochlear implant, or implantable defibrillator.
Active acute infection.
History of malignancy.
Receipt of physical therapy or rehabilitation for the wrist or surrounding area within the past 6 months.
Corticosteroid injection to the wrist within the past 6 months.
Hyperthyroidism or adrenal gland hyperfunction.
Open growth plates (epiphyseal plates not closed).
Paroxysmal neurological disorders (e.g., epilepsy).
Myasthenia gravis.
Regular use of pain medications such as pregabalin, duloxetine, or non-steroidal anti-inflammatory drugs (NSAIDs).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Group 1 (Magnetotherapy Group):
Participants will receive pulsed magnetotherapy five days per week for a total of 15 sessions.
Treatment parameters will be 50 Hz frequency, 2-3 mT magnetic field intensity, and 15-20 minutes per session.
In addition, participants in this group will use a standard nighttime wrist splint and follow a standardized home exercise program consisting of nerve and tendon gliding exercises.
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Participants 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. |
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Sham Comparator: Group 2 (Placebo Magnetotherapy Group)
Participants will receive treatment using the same device, with identical appearance and session duration; however, the device will not generate a magnetic field (sham mode).
Participants in this group will also use a standard nighttime wrist splint and follow the same standardized home exercise program (nerve and tendon gliding exercises).
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Participants 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. |
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Other: Group 3 (Routine/Conservative Treatment Group)
Participants in this group will use a standard nighttime wrist splint and follow the standardized home exercise program (nerve and tendon gliding exercises).
These participants will be placed on a wait-list for magnetotherapy.
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Participants 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptom Severity Assessed by Boston Carpal Tunnel Questionnaire Symptom Severity Scale
Time Frame: Baseline (Week 0), Week 3, Month 1, Month 3
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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.
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Baseline (Week 0), Week 3, Month 1, Month 3
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Wrist Pain Intensity Assessed by Visual Analog Scale
Time Frame: Baseline (Week 0), Week 3, Month 1, Month 3
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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.
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Baseline (Week 0), Week 3, Month 1, Month 3
|
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Upper Extremity Function Assessed by Quick Disabilities of the Arm, Shoulder and Hand Questionnaire
Time Frame: Baseline (Week 0), Week 3, Month 1, Month 3
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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.
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Baseline (Week 0), Week 3, Month 1, Month 3
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Hand Grip Strength Assessed by Jamar Dynamometer
Time Frame: Baseline (Week 0), Week 3, Month 1, Month 3
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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.
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Baseline (Week 0), Week 3, Month 1, Month 3
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Sensory Function Assessed by Semmes-Weinstein Monofilament Test
Time Frame: Baseline (Week 0), Week 3, Month 1, Month 3
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Sensory function will be evaluated using the Semmes-Weinstein Monofilament Test.
Calibrated monofilaments of different thicknesses are applied to standardized fingertip locations to determine sensory threshold levels.
Monofilament values range from lower to higher force levels.
Higher threshold values indicate greater sensory impairment, whereas lower threshold values indicate better sensory function.
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Baseline (Week 0), Week 3, Month 1, Month 3
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Median Nerve Cross-Sectional Area Assessed by Ultrasonography
Time Frame: Baseline (Week 0), Week 3, Month 1, Month 3
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The cross-sectional area of the median nerve will be measured at the carpal tunnel inlet using high-resolution ultrasonography.
Values are recorded in square millimeters (mm²).
Higher cross-sectional area values indicate greater nerve swelling and worse pathological status.
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Baseline (Week 0), Week 3, Month 1, Month 3
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Clinical Signs Assessed by Tinel and Phalen Tests
Time Frame: Baseline (Week 0), Week 3, Month 1, Month 3
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The presence or absence of positive Tinel and Phalen signs will be recorded.
A positive test indicates median nerve irritation.
A reduction in the proportion of positive tests indicates clinical improvement.
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Baseline (Week 0), Week 3, Month 1, Month 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep Quality Assessed by Pittsburgh Sleep Quality Index
Time Frame: Baseline (Week 0), Week 3, Month 1, Month 3
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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.
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Baseline (Week 0), Week 3, Month 1, Month 3
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Patient Satisfaction Assessed by 5-Point Likert Scale
Time Frame: Week 3 (End of Treatment)
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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.
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Week 3 (End of Treatment)
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Collaborators and Investigators
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
Other Study ID Numbers
- CTS-MGNT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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