Effectiveness of Blood Flow Restriction Exercise Therapy to Reduce Pain in Knee Osteoarthritis Patients
- Conditions
- Knee Osteoarthritis
- Interventions
- Device: Blood Flow Restriction (BFR)Device: Sham Blood Flow Restriction (sham BFR)
- Registration Number
- NCT04917952
- Lead Sponsor
- University of West Attica
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 42
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BFR group Blood Flow Restriction (BFR) The intervention group will receive resisted knee extension 30% of 1RM with blood flow restriction. Sham BFR group Sham Blood Flow Restriction (sham BFR) The control group will receive resisted knee extension 30% of 1RM with sham blood flow restriction.
- Primary Outcome Measures
Name Time Method Change of Pain Pressure Threshold (PPT) from baseline 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
- Secondary Outcome Measures
Name Time Method Change of Dynamic weight-bearing Assessment of Pain (DAP) from baseline At baseline, Post 5 minutes, Post 24 hours DAP is correlating VAS/NRS pain reporting scales with the functional test of 30-second Chair Stand Test (30s-CST)
Change of 30-second Chair Stand Test (30s-CST) from baseline At baseline, Post 5 minutes, Post 24 hours 30s-CST is a functional assessment evaluating leg strength and dynamic balance, the more repetitions one can do during the 30'', the better the outcome
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 Pain reporting scales as NRS are using 0-10 grades to measure how big the pain is, 10 is for the worst pain