Electromagnetic Transduction Therapy (EMTT) on Mid-foot Osteoarthritis: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) for Pain
研究概览
简要总结
The purpose of this study is to determine if Electromagnetic Transduction Therapy (EMTT) is a viable treatment option in patients with osteoarthritis of the foot and/or ankle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Men and women with osteoarthritis of the foot and/or ankle confirmed via radiographs.
排除标准
- •Pacemaker, active cancer, shrapnel, metal in eye, implantable devices that are not compatible with MRIs, concurrent foot or ankle condition or injury, prior foot or ankle surgery for osteoarthritis, steroid, platelet rich plasma, or hyaluronic acid injection within 2 months of the treatment.
研究组 & 干预措施
Mid-foot osteoarthritis
干预措施: Electromagnetic Transduction Therapy (EMTT) (Device)
结局指标
主要结局
Visual Analog Scale (VAS) for Pain
时间窗: Baseline, 3 weeks, 3 months, 6 months
The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.
Foot and Ankle Ability Measure (FAAM)
时间窗: Baseline, 3 weeks, 3 months, 6 months
The Foot and Ankle Ability Measure (FAAM) ADL is a 21-item self-report questionnaire measuring Activities of Daily Living. Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. Item score totals, which range from 0 to 84 are reported in percentage scores. Higher scores represent higher levels of function, with 100% representing no dysfunction.
次要结局
未报告次要终点
研究者
Elizabeth Bondi
Principal Investigator
Mayo Clinic