NCT04753567Unknown不适用
nCap Medical Nano-Capacitive Pain Relief Patch vs Placebo, a Prospective Randomized Controlled Trial
nCap Medical2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年4月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Pain score using VAS scale
研究概览
简要总结
The purpose of this study is to determine whether use of the nCap Medical Nano-Capacitive pain relief patch reduces subject pain as measured by subject pain scores, WOMAC scores (pain, stiffness and physical function), global assessment scores, and pain medication change as compared to participants randomly assigned to the sham patch group.
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, Investigator)
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet Altman's clinical criteria for Knee Osteoarthritis
- •Male and Female Adults age 40-79
- •VAS pain score of > 4 at the beginning of the study
排除标准
- •Subject unable to walk unassisted. Participants must be able to stand/walk for 30 minutes
- •Inability to read and understand English. Must be able to complete WOMAC scale and questionnaires
- •Severe systemic disease limiting ability to ambulate for 30 minutes
- •Use of a TENS unit for one week before study or during study
- •History of total knee replacement on the affected knee
- •Knee surgery on the affected knee in the last 12 months
- •Injection into the knee in the last 6 months
- •Knee pain < 411
- •Inability to cognitively understand consent form or research study, or inability to give consent
- •Diagnosis of fibromyalgia, rheumatoid arthritis, gout, dysplasia, septic arthritis, knee pain from other diseases.
- •Malignancy
- •Injury to knee within 6 months
- •Concomitant use of opioids, NSAIDS or other analgesics for 1 week before trial (or 5 half-lives, whichever is greater)9, or during trial with exception of acetaminophen.
- •Pregnant or lactating
- •Poor general health (ASA classification of IV+)
结局指标
主要结局
Pain score using VAS scale
时间窗: After 30 minutes of use
0-10 pain scale
次要结局
- Sustained pain response(3 weeks)
- Pain medication monitoring(3 weeks)
- Global assessment question(3 weeks)
- WOMAC score(3 weeks)
研究者
研究点 (2)
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