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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnkara University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: rPMS groupActive comparator 1 intervention
Group B: sham- rPMS groupSham comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Grip and Pinch Strength Assessment

Grip and pinch strength measurements are used to evaluate hand function and to quantitatively monitor progress throughout the treatment process. Grip strength is measured with the patient seated, shoulder adducted and neutrally rotated, elbow flexed at 90°, and the wrist in a neutral position. A Jamar dynamometer is used, and the average of three consecutive measurements is recorded. The same arm positioning is used for the pinch strength assessment. Three types of pinch are evaluated with a pinch gauge. Palmar pinch is assessed by bringing the thumb, index, and middle fingertips together. Lateral pinch is performed by pressing the distal phalanx of the thumb against the lateral surface of the middle phalanx of the index finger. Tip-to-tip pinch is evaluated by forming an "O" shape with the tips of the thumb and index finger. Each measurement is performed three times, and the average is recorded as kilograms (kg).

Time frame
baseline, three weeks after the final treatment session, and six weeks post-treatment.
2

Boston Carpal Tunnel Questionnaire (BCTQ)

The BCTQ is designed to evaluate symptom severity and functional status in patients with carpal tunnel syndrome. The questionnaire consists of two sections. The Symptom Severity Scale includes 11 items that evaluate the intensity, character, frequency, and duration of symptoms. Each item is rated on a scale from 1 (mildest) to 5 (most severe), and the final score is calculated as the arithmetic mean of all item scores. The Functional Status Scale comprises 8 items assessing the level of difficulty experienced in performing daily activities. Similar to the symptom scale, each item is scored between 1 and 5, and the average of these scores constitutes the final result. Higher scores in both sections indicate more severe symptoms and greater functional impairment.

Time frame
baseline, three weeks after the final treatment session, and six weeks post-treatment.
3

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

The SF-36 is a multidimensional questionnaire originally developed in the United States to evaluate general health status. The SF-36 consists of 36 items grouped into eight health domains, including physical functioning, role limitations due to physical and emotional problems, pain, general health perception, mental health, social functioning, and energy/fatigue.Each domain is scored on a 0-100 scale, where higher scores indicate better health status, lower scores reflect greater disability or poorer quality of life

Time frame
baseline, three weeks after the final treatment session, and six weeks post-treatment.
4

Electrophysiological Evaluation

All measurements will be performed at room temperature using the Keypoint®-Dantec EMG system available in our clinic. The patient will be positioned supine with the palm facing upward. For motor conduction studies, the active electrode will be placed over the abductor pollicis brevis muscle, and the reference electrode over the proximal phalanx of the thumb. Stimulation will be applied 8 cm proximally, and measurements will include distal motor latency (ms) and compound muscle action potential (CMAP, mV). For sensory conduction studies, the active electrode will be placed over the proximal phalanx of the index finger, and the reference electrode about 3-4 cm distally. Sensory conduction will be assessed orthodromically at the Digit 1-wrist, Digit 2-wrist, Palm-wrist, Digit 3-wrist, and Wrist-elbow segments.Measurements will include distal sensory latency (ms), sensory nerve action potential amplitude (SNAP, µV), and conduction velocity.

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

Other outcomes

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