Magnetotherapy in Carpal Tunnel Syndrome: Randomized Controlled Study

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

Interventions

DEVICE

Arm 1: Active Magnetotherapy Group

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.

DEVICE

Arm 2: Sham (Placebo) Magnetotherapy Group

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.

OTHER

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

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.

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2026-06-01

Completion

2026-11-01

Countries

• Turkey (Türkiye)

Study Locations