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NOT YET RECRUITING
NCT07327723
NA

Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)

Sponsor: Ankara University

View on ClinicalTrials.gov

Summary

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy, resulting from compression of the median nerve at the wrist. It is particularly common in middle-aged women. In the early stages, these patients frequently experience pain and numbness in the hand, especially in the first three fingers, and paresthesias, which often worsen at night. As the disease progresses, muscle weakness and atrophy of the thenar muscles can occur, severely impacting patients' daily activities and functionality. Clinical evaluation and patient complaints are crucial for diagnosis. Electrophysiological assessment tools such as nerve conduction studies and electromyography (EMG) are highly sensitive and considered the gold standard for confirming the diagnosis, assessing nerve damage, and determining the severity of this damage. In addition to electrophysiological assessment, ultrasonographic evaluation offers an important opportunity to observe structural changes in the median nerve associated with CTS. In cases of mild to moderate CTS, nonsurgical treatments are the primary options for reducing symptoms; splinting, tendon-nerve gliding exercises, and physical therapy modalities are commonly preferred. Repetitive peripheral magnetic stimulation (rPMS) is a non-invasive method that can be applied to various tissues, such as spinal nerves, peripheral nerves, or muscles, and is used to reduce pain and improve motor function. While its potential benefits for many neurological diseases and musculoskeletal problems have been demonstrated in recent years, there are limited studies on the effectiveness of rPMS in patients with CTS. The primary objective of this study is to evaluate the effectiveness of rPMS on pain in individuals diagnosed with mild to moderate CTS. Secondarily, the effects of rPMS on symptom severity, functional status, nerve conduction parameters, and median nerve ultrasonographic findings will be analyzed. The findings of our study suggest that objective evaluation of rPMS treatment will contribute to supporting the clinical practice of this treatment option in patients with CTS with more comprehensive data.

Official title: The Effects of Repetitive Peripheral Magnetic Stimulation on Clinical and Electrophysiological Parameters in Patients With Carpal Tunnel Syndrome: A Double-Blind, Randomized, Sham-Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-01-01

Completion Date

2027-01-15

Last Updated

2026-01-08

Healthy Volunteers

No

Interventions

DEVICE

rPMS group

All patients will be instructed in tendon and nerve gliding exercises by a physiotherapist. In addition to these exercises, the treatment group will undergo repetitive peripheral magnetic stimulation (rPMS) therapy three times per week for two consecutive weeks, for a total of six sessions. Each session will last 10 minutes. The rPMS treatment will be administered using the BTL-6000 Super Inductive System Elite device. From the device interface, the "wrist/hand" region will be selected, and the "carpal tunnel syndrome" protocol pre-programmed for this region will be applied. During the procedure, patients will be instructed to lie supine or sit in a relaxed position to ensure complete muscle relaxation in the arm. The applicator will be positioned on the volar aspect of the wrist, aligned with the carpal tunnel, as close to the skin as possible. The frequency will be set between 5-50 Hz, and intensity will be adjusted to elicit visibly observable muscle contractions.

DEVICE

sham-rPMS

In the sham group, patients will be positioned identically, and the device will be placed in the same position but not activated. Instead, previously recorded operational sounds of the device will be played back during the same duration to simulate the treatment experience. All participants will be closely monitored throughout the treatment period

Locations (1)

Ankara University, Faculty of Medicine, Cebeci Hospital, Cebeci

Ankara, Mamak, Turkey (Türkiye)