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

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

Overview

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

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
• 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

Primary outcome measures

• Visual analog scale (VAS) [Time frame: Baseline, three weeks after the final treatment session, and six weeks post-treatment.]

Secondary outcome measures (5)

• Grip and Pinch Strength Assessment [Time frame: baseline, three weeks after the final treatment session, and six weeks post-treatment.]
• Boston Carpal Tunnel Questionnaire (BCTQ) [Time frame: baseline, three weeks after the final treatment session, and six weeks post-treatment.]
• SF-36 (Short Form-36 Health Survey Questionnaire) [Time frame: baseline, three weeks after the final treatment session, and six weeks post-treatment.]
• Electrophysiological Evaluation [Time frame: baseline, three weeks after the final treatment session, and six weeks post-treatment.]
• Ultrasonographic Measurement of Median Nerve Cross-Sectional Area [Time frame: baseline, three weeks after the final treatment session, and six weeks post-treatment.]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Ankara University, Faculty of Medicine, Cebeci Hospital, Cebeci — Ankara

Identifiers

NCT: NCT07327723 · 11-480-25 · TTU-2025-4307

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗