NCT07327723

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ankara University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed as a prospective, randomized, sham-controlled, double-blind, experimental study. It was approved by the Ethics Committee of Ankara University, Faculty of Medicine, and will be conducted in accordance with the Declaration of Helsinki. The study will be conducted at the Department of Physical Medicine and Rehabilitation, Ankara University Faculty of Medicine Hospital. Eligible participants who are over 18 years of age, have provided informed consent, and have clinical symptoms and physical examination findings consistent with carpal tunnel syndrome (CTS), along with electrodiagnostic confirmation of mild to moderate CTS, will be enrolled. Participants will randomly be assigned to two groups: a treatment group and a sham group. Randomization will be performed using the Random Allocation Software (RAS) program. 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. rPMS will be applied by a physiotherapist who is blinded to the participants' diagnoses and outcome evaluations. All participants will be carefully monitored throughout the intervention period. Assessments will be conducted at three time points: baseline, three weeks after the final treatment session, and six weeks post-treatment. Participants will be assessed by Dr. Sema Köylü Dağ, who will be blinded to patient group allocation and diagnosis, using the case report form. In line with this form, sociodemographic data, including age, sex, height, weight, body mass index (BMI), marital status, educational level, occupation, and contact information, will be recorded, along with medical history, symptom duration, smoking status, dominant hand, and affected hand. Assessments will include the Visual Analog Scale (VAS), grip and pinch strength measurements (kg), the Boston Carpal Tunnel Questionnaire (BCTQ), the Short Form-36 Health Survey (SF-36), electrophysiological evaluation of the median nerve, and ultrasonographic cross-sectional area measurement (mm²) of the median nerve. Statistical Analysis Sample size was calculated based on the primary endpoint: detecting a clinically meaningful difference in Visual Analog Scale (VAS) scores between the two groups, with a mean effect size of 1.4. Assuming a significance level of α = 0.05 and power = 0.95, the required sample size was calculated as 15 patients per group (30 patients in total). Calculations were performed using the GPower 3.1 software. Considering possible dropouts, the plan is to recruit 20 participants per group, totaling 40 patients. Descriptive statistics will be presented as mean ± standard deviation, median (minimum-maximum), and frequency (percentage). For between-group comparisons, Student's t-test and chi-square test will be used. For within-group comparisons, repeated measures ANOVA or the Friedman test will be employed. Correlations between variables will be analyzed using Pearson correlation coefficient. A p-value \< 0.05 will be considered statistically significant

Conditions

• Carpal Tunnel Syndrome (CTS)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-15
• Completion: 2027-01-15
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: Turkey (Türkiye)