Treatment of Lateral Epicondylitis With a Percussive Therapy Device: Outcomes of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Time to Improvement of Symptoms
研究概览
简要总结
The purpose of this study is to assess the efficacy of using a percussive therapy device in addition to physical therapy to treat acute tennis elbow
详细描述
The device the investigators intend to use is Class I and in a class of devices that is exempt from the FDA requirement for premarket notification/approval (exempt from 510K or PMA), which would not be "subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act" (ref: FDAAA Checklist)
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
- Single (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
- •Individuals 18 years old or older are included
- •Patients with atraumatic lateral epicondylitis symptoms
- •Symptoms persistent and present for at least 2 weeks
- •Presence of 2 of the following on clinical examination: +tenderness to palpation common extensor tendons and/or lateral epicondyle origin, pain over the lateral elbow with passive flexion of the wrist in an extended position, +pain with resisted supination, +pain with resisted middle finger extension.
排除标准
- •Any records flagged "break the glass" or "research opt out."
- •Patients with elbow osteoarthritis,
- •Patients with a history of traumatic injury to the elbow
- •Patients with workers compensation
- •Patients who received cortisol injection in the elbow
- •MRI evidence of common extensor tear
- •A history of surgery on the affected elbow,
- •Cognitive or behavioral problems which would preclude informed consent.
- •Patients with coagulopathies
- •Patients who are pregnant
- •Patients who had a cortisone injection within 3 months
研究组 & 干预措施
Percussive Therapy Device
Participants will be going to physical therapy - 1 session per week for 6 weeks and will use a percussive therapy device daily for 3-7 minutes
干预措施: Percussive Therapy Device (Device)
Percussive Therapy Device
Participants will be going to physical therapy - 1 session per week for 6 weeks and will use a percussive therapy device daily for 3-7 minutes
干预措施: Physical Therapy (Behavioral)
Control group
Participants will be going to physical therapy - 1 session per week for 6 weeks
干预措施: Physical Therapy (Behavioral)
结局指标
主要结局
Time to Improvement of Symptoms
时间窗: 3 months
次要结局
- PROMIS Upper Extremity(3 months)
- PROMIS Physical Functioning(3 months)
- PROMIS Pain Interference(3 months)
- SANE score(3 months)
- PROMIS Depression(3 months)
- VAS pain score(3 months)
研究者
Michael Stone
Principal Investigator, Assistant Professor, Orthopedic Surgeon
Cedars-Sinai Medical Center