NCT05723809尚未招募不适用
Treatment of Lateral Epicondylitis With a Percussive Therapy Device: Outcomes of a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 2
- 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
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
研究点 (2)
Loading locations...
相似试验
Unknown
3 期
VIBration Training in EpicondylitiSEpicondylitisPainTendinopathyNCT01269879Hannover Medical School70
已完成
不适用
Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema in Pregnant WomenPregnancy ComplicationsEdema LegPhysiotherapyNCT06338254Istanbul Medipol University Hospital60
招募中
不适用
Effectiveness of Extracorporeal Shockwave Therapy and Nutraceutical Supplementation in the Treatment of Epicondylitis: a Clinical TrialEpicondylitis, LateralEpicondylitis of the ElbowTennis ElbowNCT06442618University of Palermo45
已完成
不适用
Comparative Study for the Optimal Treatment Method of Lateral EpicondylosisTennis ElbowNCT02052089CM Chungmu Hospital231
已完成
不适用
ltrasound therapy for lateral epicondylitis. A double blind randomised placebo controlled trialISRCTN34475330Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)200