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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Pain Severity Measured by Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors (including the electroneurophysiologist) were blinded to group allocation. The physiotherapist delivering the intervention was aware of allocation but did not participate in outcome assessments.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Change in Pain Severity Measured by Visual Analog Scale (VAS)
时间窗: 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.
次要结局
- Change in Nerve Conduction Velocity (NCV)(Baseline, week 4, and week 8)
- Change in Neuropathic Pain Assessed by Douleur Neuropathique 4 (DN4)(Baseline, week 4, and week 8)
- Change in Pain Severity and Interference Assessed by Brief Pain Inventory (BPI)(Baseline, week 4, and week 8)
- Change in Health-Related Quality of Life Assessed by Nottingham Health Profile (NHP)(Baseline, week 4, and week 8)
- Change in Muscle Strength Assessed by Manual Muscle Testing (MRC Scale)(Baseline, week 4, and week 8)
- Change in Compound Muscle Action Potential (CMAP) Amplitude(Baseline, week 4, and week 8)
- Change in Distal Motor Latency(Baseline, week 4, and week 8)
- Change in Mean Motor Unit Potential (MUP) Duration(Baseline, week 4, and week 8)
- Change in Mean Motor Unit Potential (MUP) Amplitude(Baseline, week 4, and week 8)
研究者
Nurdan Korkmaz
Associate Professor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital