Blood Flow Restricted Training to Enhance Lateral Epicondylitis Rehabilitation.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Define the effect of BFR training on pain with activity in patients with LE.
研究概览
简要总结
Lateral epicondylitis (LE), often referred to as "tennis elbow" is a common and debilitating overuse injury affecting 1-3% of adults annually. LE is most often defined as a syndrome of pain near the area of the lateral epicondyle of the elbow commonly effecting the origin of the extensor carpi radialis brevis with associated weakness; it most commonly effects the dominant arm. The best treatment for LE is unknown and research to support current treatment methods are insufficient. A common limitation in functional recovery experienced by this population is pain at the lateral aspect of the elbow. As such, innovative therapeutic interventions directed at quickly reducing pain may address this unmet need and allow for improved outcomes, as well as earlier return to function.
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, Outcomes Assessor)
盲法说明
For patients enrolled in the control group, the participants will undergo calibration of the Delfi Personalized Tourniquet System to measure limb occlusion pressure and will wear the cuff during completion of the exercises with minimal inflation (approximately 5%), to hold the cuff in place during treatment. This will act as a sham.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-65 years of age
- •Diagnosis of lateral epicondylitis confirmed by the treating orthopaedic surgeon and ultrasound
- •Must be able to read and write in English
- •Able to provide own written consent
排除标准
- •Patients over 65 years of age
- •Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength or daily pain greater than 1/10
- •History of prior injection for treatment of lateral epicondylitis
- •Recent history of deep venous thrombosis (within the past 12 months)
- •Active treatment with anticoagulants
- •History of upper quadrant lymph node dissection
- •History of endothelial dysfunction
- •Patient history of easy bruising
- •Active infection in the injured arm
- •Uncontrolled peripheral vascular disease
- •Uncontrolled diabetes mellitus
研究组 & 干预措施
Physical Therapy
For patients enrolled in the control group, the participants will undergo calibration of the Delfi Personalized Tourniquet System to measure limb occlusion pressure and will wear the cuff during completion of the exercises with minimal inflation (approximately 5%), to hold the cuff in place during treatment. This will act as a sham.
干预措施: Standard Physical Therapy (Other)
Blood Flow Restricted Physical Therapy
Physical therapy assisted by blood flow restriction per standard physical therapy protocol.
干预措施: Blood Flow Restriction Device (Device)
结局指标
主要结局
Define the effect of BFR training on pain with activity in patients with LE.
时间窗: 3 weeks to 6 months
Measured on a 0-10 scale by VAS (Visual Analog Scale) patient reported outcome form. The VAS is scored 0-10, and a higher score indicates worse pain/worse outcomes.
次要结局
未报告次要终点
研究者
Julie Nuelle
Assistant Professor of Orthopaedic Surgery, Hand Surgeon
University of Missouri-Columbia