Magnetotherapy in Carpal Tunnel Syndrome: Randomized Controlled Study

Официальное название

Evaluation of the Effectiveness of Magnetotherapy in Patients With Carpal Tunnel Syndrome: A Placebo-Controlled, Triple-Arm, Randomized, Double-Blind Study

Обзор

This study is designed to investigate the effectiveness of low-frequency pulsed electromagnetic field therapy in individuals diagnosed with mild-to-moderate carpal tunnel syndrome (CTS). This double-blind, randomized controlled trial will randomly assign participants into three groups: Group 1: Active magnetotherapy Group 2: Placebo magnetotherapy (treatment using an identical device that does not generate a magnetic field) Group 3: Routine (conservative) treatment group All participants will receive a standard nighttime wrist splint and a standardized nerve and tendon gliding exercise protocol. Magnetic field applications will be administered five days per week for a total of 15 sessions. Assessments will be conducted at baseline (T0), at the end of treatment (T1 - Week 3), at 1 month (T2), and at 3 months (T3). The primary outcome measures include the Boston Carpal Tunnel Questionnaire (BCTQ), pain intensity assessed by the Visual Analog Scale (VAS), functional status measured by QuickDASH, median nerve cross-sectional area assessed by ultrasonography, sensory function evaluated using the Semmes-Weinstein monofilament test, grip strength measured by dynamometry, and clinical test results (Tinel and Phalen tests). Secondary outcomes include sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI) and patient satisfaction. This study aims to contribute to the scientific evidence regarding the effectiveness of magnetotherapy as a non-invasive treatment option for carpal tunnel syndrome.

Подробное описание

Carpal tunnel syndrome (CTS) is a common entrapment neuropathy caused by compression of the median nerve within the carpal tunnel at the wrist, resulting in symptoms such as tingling, numbness, pain, and functional impairment in the hand and fingers. According to the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM), the diagnosis is supported electrophysiologically by delayed distal motor or sensory conduction, conduction block, or prolonged response latency of the median nerve. Clinically, CTS presents with paresthesia, pain, numbness, and functional limitations. The condition is more prevalent among middle-aged individuals, particularly office workers, homemakers, and those engaged in repetitive wrist movements. If left untreated, CTS may lead to muscle weakness and a significant decline in quality of life.

Conservative treatment options include nighttime wrist splinting, nerve mobilization exercises, pharmacological therapy, and physical therapy modalities. However, these approaches are generally symptom-oriented and may have limited long-term effectiveness.

Magnetotherapy has emerged as a non-invasive physical therapy modality with minimal side effects. Pulsed electromagnetic field (PEMF) therapy has been reported to reduce pain and improve objective nerve function in refractory CTS cases in both short- and long-term follow-up. Nevertheless, scientific evidence regarding the effectiveness of magnetotherapy in CTS remains limited, and many existing studies lack robust methodological designs such as placebo control, randomization, and blinding. Therefore, this study aims to contribute to the current literature and strengthen clinical decision-making by providing high-quality evidence on the effectiveness of magnetotherapy in CTS.

Вмешательства

• Устройство Arm 1: Active Magnetotherapy Group
  Participants assigned to this group will receive active pulsed electromagnetic field (PEMF) therapy administered five days per week for three consecutive weeks, totaling 15 treatment sessions. Each session will last 15-20 minutes. The treatment will be delivered using a clinically approved medical device set at a frequency of 50 Hz and a magnetic field intensity of 2-3 millitesla (mT). The application will be performed in a controlled clinical setting by trained healthcare personnel. In additio
• Устройство Arm 2: Sham (Placebo) Magnetotherapy Group
  Participants in this group will undergo a sham magnetotherapy procedure using the same device, with identical appearance, positioning, session duration, and application protocol as the active treatment group. However, the device will be set to a mode that does not generate a magnetic field. This approach is designed to maintain participant blinding and control for placebo effects. Similar to the active group, participants will receive standard conservative treatment consisting of nighttime wris
• Другое Arm 3: Conservative Treatment (Wait-List Control) Group
  Participants in this group will receive standard conservative management only, including nighttime wrist splinting and the standardized home-based nerve and tendon gliding exercise program. No magnetotherapy device will be applied during the study period. To ensure ethical considerations, participants in this group will be placed on a wait-list and may be offered magnetotherapy after completion of the follow-up assessments. Compliance with splint use and exercise performance will be monitored s

Первичные конечные точки

• Symptom Severity Assessed by Boston Carpal Tunnel Questionnaire Symptom Severity Scale [Срок оценки: Baseline (Week 0), Week 3, Month 1, Month 3]
• Wrist Pain Intensity Assessed by Visual Analog Scale [Срок оценки: Baseline (Week 0), Week 3, Month 1, Month 3]
• Upper Extremity Function Assessed by Quick Disabilities of the Arm, Shoulder and Hand Questionnaire [Срок оценки: Baseline (Week 0), Week 3, Month 1, Month 3]
• Hand Grip Strength Assessed by Jamar Dynamometer [Срок оценки: Baseline (Week 0), Week 3, Month 1, Month 3]
• Sensory Function Assessed by Semmes-Weinstein Monofilament Test [Срок оценки: Baseline (Week 0), Week 3, Month 1, Month 3]
• Median Nerve Cross-Sectional Area Assessed by Ultrasonography [Срок оценки: Baseline (Week 0), Week 3, Month 1, Month 3]
• Clinical Signs Assessed by Tinel and Phalen Tests [Срок оценки: Baseline (Week 0), Week 3, Month 1, Month 3]

Вторичные конечные точки (2)

• Sleep Quality Assessed by Pittsburgh Sleep Quality Index [Срок оценки: Baseline (Week 0), Week 3, Month 1, Month 3]
• Patient Satisfaction Assessed by 5-Point Likert Scale [Срок оценки: Week 3 (End of Treatment)]

Критерии участия

Критерии включения

• Adults aged between 18 and 65 years.

Clinical diagnosis of carpal tunnel syndrome (CTS) based on physical examination findings, including positive Tinel and/or Phalen tests and hypoesthesia in the 3rd to 5th digits.

Electrophysiologically confirmed mild-to-moderate carpal tunnel syndrome based on electromyography (EMG) findings.

Критерии исключения

• Severe carpal tunnel syndrome confirmed electrophysiologically by electromyography (EMG).

History of previous surgical intervention for carpal tunnel syndrome.

Presence of other peripheral nerve entrapments (e.g., ulnar nerve entrapment, radial nerve entrapment).

Electrophysiologically confirmed polyneuropathy or cervical radiculopathy/cervical discopathy.

Rheumatologic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus).

Diabetes mellitus (Type 1 or Type 2).

Pregnancy.

Presence of electronic implants such as cardiac pacemaker, cochlear implant, or implantable defibrillator.

Active acute infection.

History of malignancy.

Receipt of physical therapy or rehabilitation for the wrist or surrounding area within the past 6 months.

Corticosteroid injection to the wrist within the past 6 months.

Hyperthyroidism or adrenal gland hyperfunction.

Open growth plates (epiphyseal plates not closed).

Paroxysmal neurological disorders (e.g., epilepsy).

Myasthenia gravis.

Regular use of pain medications such as pregabalin, duloxetine, or non-steroidal anti-inflammatory drugs (NSAIDs).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Fatih Sultan Mehmet Research and Training Hospital — Istanbul

Идентификаторы

NCT: NCT07435961 · CTS-MGNT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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