The Immediate Effects of a Wrist Extensors Exercise With Blood Flow Restriction BFR in Lateral Elbow Tendinopathy. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Pressure pain threshold
研究概览
简要总结
A randomized cross-over trial comparing the immediate effects of a wrist extensor exercise with and without blood flow restriction (BFR) on pain perception in patients with lateral elbow tendinopathy (LET).
详细描述
Patients with LET will participate in the study performing an exercise with and without blood flow restriction (BFR) in a randomized order (two occasions). A target of 20 patients for enrollment has been set for 80% power, p<0.05 (Effect size= 1). Two interventions will be used lasting 40 minutes each.
Intervention: A wrist extension exercise (concentric-eccentric) with Blood Flow Restriction (30-15-15-15 reps). Exercises will be performed using dumbbells according to a pain monitoring approach (<2/10 in numerical pain rating scale).
Control Group: A wrist extension exercise (concentric-eccentric) without Blood Flow Restriction (30-15-15-15 reps). Exercises will be performed using dumbbells according to a pain monitoring approach (<2/10 in numerical pain rating scale).
Primary outcomes: pressure pain thresholds lateral epicondyle, cervical spine and tibialis anterior (bilateral).
Secondary outcome: pain free grip strength
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women diagnosed with Lateral Elbow Tendinopathy (LET)
- •Symptoms for over 2 weeks
- •Pain provoked by palpation on the lateral epicondyle
- •Positive: Cohen's test, Maudsley test, Mill's test
- •decrease in pain grip strength >5% in elbow extension compared to flexion
排除标准
- •Shoulder tendinopathy
- •Cervical radiculopathy
- •Rheumatoid arthritis
- •Neurological deficit
- •Radial nerve entrapment
- •Past treatment for the elbow before entering the study
- •Professional athletes
- •Lateral elbow tendinopathy of the same side in the last 3 years
- •Serious cardiovascular diseases
- •Venous deficiency
- •History of heart surgery
- •Cancer history
- •Breast surgery
- •Orthopaedic surgeries during the last 6 months
- •Thrombosis
- •Body mass Index ≥ 30
- •Crohn syndrome
- •Family or personal history of pulmonary embolism
结局指标
主要结局
Pressure pain threshold
时间窗: Baseline and 30 minutes
Changes between pre- and post- intervention in Pressure Pain Threshold will be measured using bilateral sites on lateral epicondyle, cervical spine and tibialis anterior. The COMPACT DIGITAL ALGOMETER CAPACITIES TO: 100 lbf / 50 kgf / 500 N, will be used by an independent assessor. The assessor will be blinded to participants' group.
次要结局
- Pain free grip strength (PFGS)(Baseline and 30 minutes)
研究者
Stefanos Karanasios
Principal Investigator
University of West Attica