High-Intensity Peripheral Magnetic Stimulation in Traumatic Peripheral Nerve Injury

Официальное название

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

Обзор

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.

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.

Вмешательства

• Устройство High-Intensity Peripheral Magnetic Stimulation
  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).
• Устройство Sham Peripheral Magnetic Stimulation
  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).
• Другое Therapeutic Exercise Program
  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.

Первичные конечные точки

• Change in Pain Severity Measured by Visual Analog Scale (VAS) [Срок оценки: Baseline, week 4, and week 8]

Вторичные конечные точки (9)

• Change in Neuropathic Pain Assessed by Douleur Neuropathique 4 (DN4) [Срок оценки: Baseline, week 4, and week 8]
• Change in Pain Severity and Interference Assessed by Brief Pain Inventory (BPI) [Срок оценки: Baseline, week 4, and week 8]
• Change in Health-Related Quality of Life Assessed by Nottingham Health Profile (NHP) [Срок оценки: Baseline, week 4, and week 8]
• Change in Muscle Strength Assessed by Manual Muscle Testing (MRC Scale) [Срок оценки: Baseline, week 4, and week 8]
• Change in Compound Muscle Action Potential (CMAP) Amplitude [Срок оценки: Baseline, week 4, and week 8]
• Change in Distal Motor Latency [Срок оценки: Baseline, week 4, and week 8]
• Change in Nerve Conduction Velocity (NCV) [Срок оценки: Baseline, week 4, and week 8]
• Change in Mean Motor Unit Potential (MUP) Duration [Срок оценки: Baseline, week 4, and week 8]
• Change in Mean Motor Unit Potential (MUP) Amplitude [Срок оценки: Baseline, week 4, and week 8]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital — Ankara

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. PMID 40304652
• 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. PMID 39359387

Идентификаторы

NCT: NCT07705490 · AEŞH-EK-2026-112

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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