Effectiveness of Blood Flow Restriction Exercise Therapy to Reduce Pain in Knee Osteoarthritis Patients (BFR;OA)

University of West Attica

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Device: Blood Flow Restriction (BFR); Device: Sham Blood Flow Restriction (sham BFR)

Study type: Interventional

Funder types: Other

Identifiers

NCT04917952

36676 - 27/04/202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

BFR group

Experimental group

Description:

The intervention group will receive resisted knee extension 30% of 1RM with blood flow restriction.

Treatment:

Device: Blood Flow Restriction (BFR)

Sham BFR group

Placebo Comparator group

Description:

The control group will receive resisted knee extension 30% of 1RM with sham blood flow restriction.

Treatment:

Device: Sham Blood Flow Restriction (sham BFR)