Effectiveness of Blood Flow Restriction (BFR) Exercise Therapy to Reduce Pain in Knee Osteoarthritis (OA) Patients. A Double-blinded Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 主要终点
- Change of Pain Pressure Threshold (PPT) from baseline
研究概览
简要总结
Resistance training of knee extensor muscles is being used in physiotherapy management in knee osteoarthritis (OA) to improve pain and physical function. Blood flow restriction (BFR) has been suggested to improve pain and increase muscle strength in healthy subjects and certain diseases. Although there are clinical studies suggesting improvements in knee osteoarthritis symptoms after 4-12 weeks of exercise with BFR, the acute effects of the intervention have not been known.
This study aims to assess the effectiveness of low load exercise therapy combined with BFR on acute pain reduction and within 24 hours post-intervention on people with knee OA compared to a placebo group.
This study will take place in Athens, Greece, as part of the postgraduate MSc program of the Physiotherapy department of the University of West Attica.
详细描述
A double-blinded randomised clinical trial with a total of 42 participants will be randomly assigned to the intervention (n=21) or the control group (n=21).
The intervention group will complete a single exercise session with BFR 80%, 30% 1RM, while the control group will have sham BFR, 30% 1RM.
Pain Pressure Threshold (PPT) will be assessed with the use of a digital pressure dynamometer.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current osteoarthritis clinical diagnosis according to either European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) criteria
- •VAS/NRS Knee pain ≥3/10 during activity
排除标准
- •Previous experience with BFR
- •Has followed knee exercise or kinesiotherapy program in the past 3 months
- •New medicines in the past 3 months
- •Any lower limb surgery in the past 6 months
- •Knee arthroplasty surgery (Knee replacement)
- •Any active healing process affecting walking (fracture, sprain, strain, etc.)
- •Diagnosed with rheumatologic/neurologic disease affecting functionality
- •Diagnosed or history of heart or vascular diseases
- •Diagnosed with respiratory/metabolic disease
- •Personal history of cancer
- •Cognitive problems
- •Pregnancy (only for female participants)
- •Any other indication not to participate in exercise
结局指标
主要结局
Change of Pain Pressure Threshold (PPT) from baseline
时间窗: At baseline, Post 5 minutes, Post 24 hours
Pain will be measured with a digital dynamometer. Raise of the PPT value means a better outcome
次要结局
- Change of Dynamic weight-bearing Assessment of Pain (DAP) from baseline(At baseline, Post 5 minutes, Post 24 hours)
- Change of 30-second Chair Stand Test (30s-CST) from baseline(At baseline, Post 5 minutes, Post 24 hours)
- Change of pain score from baseline with the use of reporting scales Visual Analogue Scale (VAS) / Numeric Rating Scale (NRS)(At baseline, Post 5 minutes, Post 24 hours)
研究者
Christos Anagnostis
Principal Investigator
University of West Attica