Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
Long-Term Objective: Determine if high-frequency PEMF therapy reduces pain in patients with thumb carpometacarpal (CMC) joint osteoarthritis (OA).
Study Design and Methods: This will be a randomized controlled pilot study with 60 subjects with CMC OA randomly divided in two groups. Thirty subjects will receive high-frequency PEMF therapy overlying the CMC joint overnight daily for four weeks. The other 30 subjects will receive a sham PEMF therapy device applied to the same joint overnight daily for four weeks. Pain and function questionnaires will be obtained for all patients at enrollment, four weeks, and six weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •an existing diagnosis of CMC OA by a hand specialist based on clinically (tenderness to palpation at the CMC joint and/or positive CMC grind test) and/or radiographically identified CMC OA
- •reported pain intensity during activities of daily living less than 7 on the Numeric Pain Rating Scale (NPRS)
排除标准
- •unable to consent
- •with current infection in hand or upper extremity
- •have had prior fracture, significant hand injury, tenosynovitis, complex regional pain syndrome, and/or Dupuytren's disease affecting the thumb
- •history of surgical or procedural intervention for CMC OA in the hand of study interest
- •do not speak English
- •have hand or wrist implants
- •have heart or brain implants
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: 4 weeks
NPRS is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
次要结局
- Numeric Pain Rating Scale (NPRS)(6 weeks)
- Patient-Rated Wrist/Hand Evaluation (PRWHE)(6 weeks)
- Single Assessment Numeric Evaluation (SANE)(6 weeks)
研究者
Raymond Chou
Clinical Assistant Professor of Orthopaedic Surgery
Stanford University