Magnetotherapy in Carpal Tunnel Syndrome: Randomized Controlled Study

NCT07435961 | Not Yet Recruiting

• 1 other identifier: CTS-MGNT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Magnetotherapy; Carpal Tunnel Syndrome (CTS); Median Nerve Compression

Keywords

median nerve compression; carpal tunnel syndrome(cts); magnetotherapy

Outcome Measures

Primary Outcomes (7)

• 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.

  Baseline (Week 0), Week 3, Month 1, Month 3

• 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.

  Baseline (Week 0), Week 3, Month 1, Month 3

• 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.

  Baseline (Week 0), Week 3, Month 1, Month 3

• 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.

  Baseline (Week 0), Week 3, Month 1, Month 3

• Sensory Function Assessed by Semmes-Weinstein Monofilament Test

  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.

  Baseline (Week 0), Week 3, Month 1, Month 3

• Median Nerve Cross-Sectional Area Assessed by Ultrasonography

  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.

  Baseline (Week 0), Week 3, Month 1, Month 3

• Clinical Signs Assessed by Tinel and Phalen Tests

  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.

  Baseline (Week 0), Week 3, Month 1, Month 3

Secondary Outcomes (2)

• Sleep Quality Assessed by Pittsburgh Sleep Quality Index

  Baseline (Week 0), Week 3, Month 1, Month 3

• Patient Satisfaction Assessed by 5-Point Likert Scale

  Week 3 (End of Treatment)

Study Arms (3)

Group 1 (Magnetotherapy Group):

ACTIVE COMPARATOR

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.

Device: Arm 1: Active Magnetotherapy Group

Group 2 (Placebo Magnetotherapy Group)

SHAM COMPARATOR

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).

Device: Arm 2: Sham (Placebo) Magnetotherapy Group

Group 3 (Routine/Conservative Treatment Group)

OTHER

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.

Other: Arm 3: Conservative Treatment (Wait-List Control) Group

Interventions

Arm 3: Conservative Treatment (Wait-List Control) Group OTHER

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.

Group 3 (Routine/Conservative Treatment Group)

Arm 1: Active Magnetotherapy Group DEVICE

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.

Group 1 (Magnetotherapy Group):

Arm 2: Sham (Placebo) Magnetotherapy Group DEVICE

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.

Group 2 (Placebo Magnetotherapy Group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Research and Training Hospital

Istanbul, Istanbul, 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

Orçun Ünalan, medical doctor

CONTACT

+905337335856; orcununalan@gmail.com

Pınar Akpınar, medical doctor

CONTACT

+905057877442; pinar.pinarakpinar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the researcher/ evaluator and the particapant are blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Model Details: Prospective, Randomized, Placebo-Controlled, Double-Blind Study

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)