High-Intensity Peripheral Magnetic Stimulation in Traumatic Peripheral Nerve Injury
Clinical and Electrophysiological Evaluation of the Effect of High-Intensity Peripheral Magnetic Stimulation in Traumatic Peripheral Nerve Injury: A Randomized, Double-Blind, Sham-Controlled Trial
Traumatic peripheral nerve injury is a common cause of chronic neuropathic pain, muscle weakness, and functional limitation, particularly in young and active individuals. Current conservative and pharmacological treatments often provide incomplete relief or carry side effects. High-intensity peripheral magnetic stimulation (PMS) is a non-invasive method that may help reduce neuropathic pain and support motor recovery, but evidence in traumatic nerve injury is limited.
This randomized, double-blind, sham-controlled trial aims to evaluate whether high-intensity PMS, added to a standardized therapeutic exercise program, improves pain, function, quality of life, and electrophysiological measures in adults with traumatic peripheral nerve injury. Participants will be randomly assigned to receive either active PMS or sham PMS, in addition to the same exercise program. Outcomes will be assessed at baseline, 4 weeks, and 8 weeks.
Обзор исследования
Статус
Условия
Подробное описание
This is a prospective, randomized, double-blind, sham-controlled clinical trial conducted at a single center. Adults aged 18-65 years with unilateral traumatic peripheral nerve injury confirmed by electromyography, with symptom onset at least 3 months prior, neuropathic pain (DN4 ≥ 4), pain severity (VAS ≥ 4), and reduced muscle strength (MRC < 5) will be enrolled.
Participants will be randomly allocated using computer-generated randomization to one of two groups: (1) active high-intensity PMS plus a standardized therapeutic exercise program, or (2) sham PMS plus the same exercise program. Active stimulation will be delivered using a high-intensity magnetic stimulation system with a predefined neuropathy protocol (approximately 10 minutes per session, variable frequencies 1-60 Hz) applied over the injured peripheral nerve, for a total of 9 sessions over 3 weeks (3 sessions per week). In the sham group, the applicator coil will be reversed to prevent effective delivery of the magnetic field, while device screen and audible feedback are maintained. Both groups will receive an individualized exercise program (active range of motion, strengthening, stretching, proprioception and balance exercises, and occupational therapy) for 20 minutes per day, 5 days per week, over 3 weeks.
Participants and outcome assessors will be blinded to group allocation. The physiotherapist delivering the intervention will be aware of allocation but will not participate in assessments. Electrophysiological evaluations will be performed by a blinded electroneurophysiologist.
The primary outcome is pain severity measured by the Visual Analog Scale (VAS). Secondary outcomes include the Douleur Neuropathique 4 (DN4) questionnaire, the Brief Pain Inventory (BPI), the Nottingham Health Profile (NHP), Manual Muscle Testing (MRC scale), and electrophysiological parameters including compound muscle action potential (CMAP) amplitude, distal latency, nerve conduction velocity (NCV), and quantitative motor unit potential (MUP) analysis. Assessments will be performed at baseline (week 0), week 4, and week 8. A total of 40 participants (20 per group) is planned based on an a priori sample size calculation.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Hüseyin Anıl İnan, MD
- Номер телефона: +905346159274
- Электронная почта: dranilinan@gmail.com
Места учебы
-
-
-
Ankara, Турция (Туркие), 06800
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
-
Контакт:
- Hüseyin Anıl İnan, MD
- Номер телефона: +905346159274
- Электронная почта: dranilinan@gmail.com
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Age between 18 and 65 years
- Traumatic peripheral nerve injury
- Unilateral traumatic peripheral neuropathy confirmed by electromyography (EMG)
- Nerve injury occurring at least 3 months prior
- Douleur Neuropathique 4 (DN4) score ≥ 4
- Visual Analog Scale (VAS) score ≥ 4
- Manual Muscle Testing score < 5
- No analgesic use, or stable analgesic therapy for the past month (no dose changes)
Exclusion Criteria:
- Active infection or malignancy
- Metal implant or shrapnel in the application area
- Electronic implants (e.g., cardiac pacemaker, spinal cord stimulator, deep brain stimulator)
- Central nervous system diseases
- Non-traumatic causes of neuropathy (e.g., radiculopathy, diabetic neuropathy, entrapment neuropathies, HIV-related neuropathy, trigeminal neuralgia)
- Complete nerve injury
- Injury involving three or more peripheral nerves or plexus injury
- History of peripheral nerve surgery or injection within the past 3 months
- Active psychiatric illness
- Coagulopathy
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Active PMS plus Therapeutic Exercise
Participants receive high-intensity peripheral magnetic stimulation (PMS) applied over the injured peripheral nerve using a predefined neuropathy protocol (approximately 10 minutes per session, variable frequencies 1-60 Hz), for a total of 9 sessions over 3 weeks (3 sessions per week).
Stimulation intensity is increased until motor activity is elicited and kept constant during the session.
In addition, participants receive a standardized therapeutic exercise program (active range of motion, strengthening, stretching, proprioception and balance exercises, and occupational therapy) for 20 minutes per day, 5 days per week, over 3 weeks.
|
High-intensity peripheral magnetic stimulation delivered via an inductive coil placed over the injured peripheral nerve, using a predefined neuropathy protocol (approximately 10 minutes per session, variable frequencies 1-60 Hz).
Stimulation intensity is increased until motor activity is elicited and kept constant during the session.
Applied 3 times per week for 3 weeks (9 sessions total).
Standardized individualized therapeutic exercise program including active range of motion exercises, strengthening exercises, stretching exercises, proprioception and balance exercises, and occupational therapy for activities of daily living.
Delivered for 20 minutes per day, 5 days per week, over 3 weeks.
|
|
Фальшивый компаратор: Sham PMS plus Therapeutic Exercise
Participants receive sham peripheral magnetic stimulation using the same device, session duration, and application site, but with the applicator coil reversed to prevent effective delivery of the magnetic field to the target tissue.
Device screen and audible feedback are maintained to preserve blinding.
In addition, participants receive the same standardized therapeutic exercise program (active range of motion, strengthening, stretching, proprioception and balance exercises, and occupational therapy) for 20 minutes per day, 5 days per week, over 3 weeks.
|
Standardized individualized therapeutic exercise program including active range of motion exercises, strengthening exercises, stretching exercises, proprioception and balance exercises, and occupational therapy for activities of daily living.
Delivered for 20 minutes per day, 5 days per week, over 3 weeks.
Sham peripheral magnetic stimulation using the same device, session duration, and application site, with the applicator coil reversed to prevent effective delivery of the magnetic field to the target tissue.
Device screen and audible feedback are maintained to preserve blinding.
Applied 3 times per week for 3 weeks (9 sessions total).
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Pain Severity Measured by Visual Analog Scale (VAS)
Временное ограничение: Baseline, week 4, and week 8
|
Pain severity assessed using the Visual Analog Scale (VAS), a 0-10 cm scale where 0 indicates "no pain" and 10 indicates "unbearable pain."
Higher scores indicate greater pain severity.
|
Baseline, week 4, and week 8
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Neuropathic Pain Assessed by Douleur Neuropathique 4 (DN4)
Временное ограничение: Baseline, week 4, and week 8
|
Neuropathic pain assessed using the Douleur Neuropathique 4 questionnaire, a 10-item instrument based on patient-reported symptoms and clinical examination findings.
Scores range from 0 to 10, with a total score of 4 or higher indicating neuropathic pain.
Higher scores indicate a worse outcome.
|
Baseline, week 4, and week 8
|
|
Change in Pain Severity and Interference Assessed by Brief Pain Inventory (BPI)
Временное ограничение: Baseline, week 4, and week 8
|
Pain severity and pain interference assessed using the Brief Pain Inventory Short Form.
Pain severity is scored from 0 to 10 (0 = no pain, 10 = pain as bad as you can imagine) and pain interference is scored from 0 to 10 (0 = does not interfere, 10 = completely interferes) across general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Higher scores indicate a worse outcome.
|
Baseline, week 4, and week 8
|
|
Change in Health-Related Quality of Life Assessed by Nottingham Health Profile (NHP)
Временное ограничение: Baseline, week 4, and week 8
|
Health-related quality of life assessed using the Nottingham Health Profile.
Each of the six sections (pain, physical mobility, energy level, sleep, social isolation, and emotional reactions) is scored from 0 to 100.
Higher scores indicate a worse outcome (greater impairment in quality of life).
|
Baseline, week 4, and week 8
|
|
Change in Muscle Strength Assessed by Manual Muscle Testing (MRC Scale)
Временное ограничение: Baseline, week 4, and week 8
|
Muscle strength assessed by manual muscle testing using the Medical Research Council scale in muscle groups innervated by the affected peripheral nerve.
Scores range from 0 (no visible contraction) to 5 (full strength against resistance).
Higher scores indicate a better outcome.
|
Baseline, week 4, and week 8
|
|
Change in Compound Muscle Action Potential (CMAP) Amplitude
Временное ограничение: Baseline, week 4, and week 8
|
CMAP amplitude of the affected nerve measured by nerve conduction studies, reported in millivolts (mV).
Higher values indicate better motor nerve function.
|
Baseline, week 4, and week 8
|
|
Change in Distal Motor Latency
Временное ограничение: Baseline, week 4, and week 8
|
Distal motor latency of the affected nerve measured by nerve conduction studies, reported in milliseconds (ms).
Higher values indicate worse nerve conduction.
|
Baseline, week 4, and week 8
|
|
Change in Nerve Conduction Velocity (NCV)
Временное ограничение: Baseline, week 4, and week 8
|
Motor nerve conduction velocity of the affected nerve measured by nerve conduction studies, reported in meters per second (m/s).
Higher values indicate better nerve conduction.
|
Baseline, week 4, and week 8
|
|
Change in Mean Motor Unit Potential (MUP) Duration
Временное ограничение: Baseline, week 4, and week 8
|
Mean duration of motor unit potentials in the affected muscle, assessed by quantitative needle electromyography and reported in milliseconds (ms).
Increased duration indicates chronic reinnervation.
|
Baseline, week 4, and week 8
|
|
Change in Mean Motor Unit Potential (MUP) Amplitude
Временное ограничение: Baseline, week 4, and week 8
|
Mean amplitude of motor unit potentials in the affected muscle, assessed by quantitative needle electromyography and reported in microvolts (µV).
Increased amplitude indicates chronic reinnervation.
|
Baseline, week 4, and week 8
|
Соавторы и исследователи
Следователи
- Главный следователь: Nurdan Korkmaz, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Публикации и полезные ссылки
Общие публикации
- Kulchitskaya, D. B., Fesyun, A. D., Yurova, O. V., Konchugova, T. V., Yakovlev, M. Y., Apkhanova, T. V., ... & Kudryavtsev, A. E. (2023). High-intensity pulsed magnetotherapy in the rehabilitation programme of patients with chemotherapy-induced peripheral polyneuropathy: a prospective randomized clinical study. Bulletin of Rehabilitation Medicine, 22(5), 72-82.
- Brown L, Gage E, Cordner H, Kapural L, Rosenberg J, Bedder M. Safety and Efficacy of Magnetic Peripheral Nerve Stimulation for Treating Painful Diabetic Neuropathy. Neuromodulation. 2025 Dec;28(8):1366-1373. doi: 10.1016/j.neurom.2025.03.074. Epub 2025 Apr 30.
- Kapural L, Patel J, Rosenberg JC, Li S, Amirdelfan K, Bedder M. Safety and Efficacy of Axon Therapy (SEAT Study), Utilizing Magnetic Peripheral Nerve Stimulation (mPNS) for Treatment of Neuropathic Pain. J Pain Res. 2024 Sep 28;17:3167-3174. doi: 10.2147/JPR.S481944. eCollection 2024.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- AEŞH-EK-2026-112
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .