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

NCT07327723 | Not Yet Recruiting

• 2 other identifiers: 11-480-25TTU-2025-4307
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

Carpal Tunnel Syndrome; Repetitive Peripheral Magnetic Stimulation; electrodiagnosis; ultrasound; functional status

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (VAS)

  The Visual Analog Scale is a tool used to quantitatively assess pain intensity. It consists of a 10 cm horizontal line, with opposing descriptors at each end. The left end represents "no pain," and the right end represents "worst imaginable pain." Patients are asked to mark a point along the line that best represents the average level of pain they experience. The distance from the left endpoint to the point marked by the participant will be measured in centimeters and recorded as a VAS pain score.

  Baseline, three weeks after the final treatment session, and six weeks post-treatment.

Secondary Outcomes (5)

• Grip and Pinch Strength Assessment

  baseline, three weeks after the final treatment session, and six weeks post-treatment.

• Boston Carpal Tunnel Questionnaire (BCTQ)

  baseline, three weeks after the final treatment session, and six weeks post-treatment.

• SF-36 (Short Form-36 Health Survey Questionnaire)

  baseline, three weeks after the final treatment session, and six weeks post-treatment.

• Electrophysiological Evaluation

  baseline, three weeks after the final treatment session, and six weeks post-treatment.

• Ultrasonographic Measurement of Median Nerve Cross-Sectional Area

  baseline, three weeks after the final treatment session, and six weeks post-treatment.

Study Arms (2)

rPMS group

ACTIVE COMPARATOR

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

Device: rPMS group

sham- rPMS group

SHAM COMPARATOR

All patients will be instructed in tendon and nerve gliding exercises by a physiotherapist. In addition to these exercises, the sham-rPMS group will receive sham repetitive peripheral magnetic stimulation (rPMS) therapy, three times per week for two weeks, totaling six sessions. Each session will last 10 minutes. 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.

Device: sham-rPMS

Interventions

sham-rPMS DEVICE

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

sham- rPMS group

rPMS group DEVICE

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.

rPMS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University, Faculty of Medicine, Cebeci Hospital, Cebeci

Ankara, Mamak, 06620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Central Study Contacts

Seçilay Güneş, Associated Professor

CONTACT

+905325562057; yalices@hotmail.com

Sema Köylü Dağ, Research assistant (MD)

CONTACT

03125082822; semakoylu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Model Details: A Double-Blind, Randomized, Sham-Controlled Trial

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: January 8, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)