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
- 2
- 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
研究组 & 干预措施
Wrist extensor exercise with Blood Flow Restriction
Blood flow restriction training. Patients will execute a wrist extension exercise on standing position with the elbow extended. The load (dumbbells) will be set according to a pain monitoring approach ( exercise should not provoke pain >2/10) during wrist extension. Load is increased by 0.5 to 1kg. We will allow a 30 sec break. The session starts by calculating the arterial occlusion pressure in the standard anatomical position. Participants rest in the standing position for 3-5 minutes before measurement to ensure restoration of blood flow circulation and a cuff is placed in the most proximal part of their dominant upper-limb. BFR application is conducted by using an automatic personalized tourniquet system (Mad-Up Pro, France).
An 40% occlusion pressure is set and subjects perform 4 sets of wrist extension (30-15-15-15 reps).
干预措施: Exercise with Blood Flow Restriction (BFR) (Other)
Wrist extensor exercise without Blood Flow Restriction
Patients will execute a wrist extension exercise on standing position with the elbow extended. The load (dumbbells) will be set according to a pain monitoring approach ( exercise should not provoke pain >2/10) during wrist extension. Load is increased by 0.5 to 1kg. We will allow a 30 sec break.
干预措施: Exercise without Blood Flow Restriction (BFR) (Other)
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