NCT07435961

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Fatih Sultan Mehmet Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-06-01
• Completion: 2026-11-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Turkey (Türkiye)