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Clinical Trials in Turkey / NCT07327723
Starting soon Not applicable

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

NCT07327723 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-01-01
Last updated
2026-01-08

Condition(s) studied

Carpal Tunnel Syndrome (CTS)

Investigational drug(s) / intervention(s)

rPMS groupsham-rPMS

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.

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * Voluntary participation with signed informed consent * Presence of symptoms consistent with carpal tunnel syndrome (CTS) (pain and/or paresthesia in the median nerve distribution), clinical signs (i.e., positive Tinel's and/or Phalen's test results), and electrodiagnostic findings (demonstrating mild to moderate CTS based on sensory or motor conduction studies of the median nerve) Exclusion Criteria: * Electrodiagnostic evidence of severe CTS * Abnormal ulnar nerve conduction findings * History of surgery for CTS * History of physical therapy or injection for CTS within the past 6 months * History of wrist fracture * Presence of other conditions causing similar symptoms, such as polyneuropathy, cervical radiculopathy, ulnar neuropathy, brachial plexopathy, or thoracic outlet syndrome * Central nervous system disorders (e.g., stroke, multiple sclerosis, Parkinson's disease) * Pregnancy * Presence of risk factors for CTS such as rheumatologic diseases, chronic kidney disease, diabetes mellitus, or hypothyroidism * Malignancy * Contraindications to rPMS (e.g., pacemaker, cochlear implant)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ankara University, Faculty of Medicine, Cebeci Hospital, Cebeci Ankara Mamak

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07327723 on ClinicalTrials.gov ↗ ← All trials in Turkey