A Prospective, Randomized, Clinical Trial Comparing the Safety and Effectiveness of Axon Therapy for Post-Traumatic Peripheral Neuropathic Pain (PTPNP) to Conventional Medical Management (CMM)
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 61
- 试验地点
- 6
- 主要终点
- Comparison of the Proportion of Responders
研究概览
简要总结
Compare Axon Therapy using transcutaneous magnetic stimulation (tMS) against conventional medical management in treating post-traumatic peripheral neuropathic pain (PTPNP).
详细描述
Subjects will be consented, screened, and undergo a 7-day baseline assessment to measure pain scores and assess diary compliance. Subjects who meet inclusion criteria will undergo an in-clinic baseline evaluation, receive randomization assignment, and start their respective treatments.
Those randomized to the CMM plus Axon Therapy group will receive their first Axon Therapy treatment and then have a follow-up phone call after 24 hours to assess if the patient is a candidate for Axon Therapy, that is if the subject is neuropathic or nociceptive. Those that are not candidates for Axon Therapy will be monitored for 30 days for AEs and then they will exit the study as screen failures. Screen failures will not count against enrollment numbers.
All subjects will return to the clinic for follow-up assessment at Day 30 (± 14 days), Day 90 (± 14 days), Day 180 (± 14 days) and Day 365 (± 30 days) and if in the CMM plus Axon Therapy group will return to the clinic for Axon Therapy treatments as follows:
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Month 1: 6 treatments
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WEEK 1: 3 treatments (consecutive treatments are best)
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WEEK 2-4: Weekly treatments
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Month 2: Bi-Weekly treatment
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Months 3-12: Treatments every 2-4 weeks
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Additional treatments to treat flare ups; defined as an episode of pain with a VAS >greater or equal to 6 following an increase in daily activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Comparison of the Proportion of Responders
时间窗: 90 days
The primary effectiveness endpoint is a between groups comparison of the proportion of responders, defined as a subject who experiences 50% or greater reduction from baseline in neuropathic pain intensity as measured by in-clinic visual analog score (VAS) for primary area of pain at Day 90 with no increase in baseline pain medications within 4 weeks of the Day 90 visit.
次要结局
- Depression Anxiety Stress Scales (DASS)(90 days)
- Patient Global Impression of Change (PGIC)(90 days)
- Visual Analog Scale (VAS) for Pain(30 and 90 days)
- Brief Pain (BPI Inventory(90 days)
- Daily Sleep Interference Scale (DSIS)(30 and 90 days)
- 5D-5D-3L(90 days)
- Pain Disability Index (PDI)(90 days)
