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Blood flow restriction exercise and pain education for knee osteoarthritis

Tests exercise with restricted blood flow plus pain education in people with knee osteoarthritis.

Key facts

Who runs it
University of Hail
Where
Saudi Arabia1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
BFR Training and Knee Osteoarthritis
Status
Recruiting
People taking part
90 people, planned
Started
15 Jun 2026
Expected to end
30 Dec 2026
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Standard Treatment
  • Pain neuroscience education
  • Blood flow restriction training
Record updated
10 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with knee osteoarthritis in one knee. It tests blood flow restriction training and pain education added to standard physical therapy.

Age
40 to 70 years
Sex
Men and women
Disease stage
Osteoarthritis in one knee only, confirmed by exam and X-ray, Kellgren-Lawrence grade 2 or 3.
Earlier treatment
No injections into the joint within the last 3 months.

Main reasons for not taking part

  • Peripheral vascular disease (poor blood flow in the limbs)
  • Active cancer
  • Infection or open wound on the leg
  • Uncontrolled heart or nerve conditions that limit exercise
  • Cognitive or psychiatric disorders

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • Male and female Age ≥ 40years
  • Clinical and radiographic diagnosis of unilateral knee osteoarthritis KOA (Kellgren-Lawrence grade 2, or 3)
  • Willing to attend 3 supervised sessions/week for 8 weeks
  • Able to provide informed consent

Who cannot take part

  • Peripheral vascular disease, active cancer, lower limb infection, open wound
  • history of intra-articular injections within the last 3 months
  • medical condition that may affect their ability to perform exercise (uncontrolled cardiovascular, or neurological disorders)
  • cognitive and psychiatric disorders

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 70 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Knee osteoarthritis (KOA) is a chronic, progressive degenerative joint disease characterized by cartilage and bone degeneration, synovial inflammation, and structural changes. Clinically, it presents with pain, morning stiffness, swelling, crepitus, and limited range of motion, leading to functional impairment, gait abnormalities, and reduced quality of life. Globally, KOA affects ~302 million people. In Saudi Arabia, prevalence rises from 30.8% (ages 46-55) to >60% (ages 66-75), with higher rates in older, female, and obese individuals. Key risk factors include aging, female sex, obesity, prior knee injury, and genetics. The condition imposes significant health burdens and socioeconomic costs.

Read full original descriptionShow less

The International Classification of Functioning, Disability, and Health (ICF) identifies KOA as a major cause of physical disability. Pain, restricted motion, and muscle weakness drive quality-of-life decline. While pharmacological treatments exist, physical therapy interventions (education, exercise, weight loss) are crucial, though their success depends on patient behavioral change.

Traditional biomedical education inadequately addresses chronic pain. Pain neuroscience education (PNE) teaches the biology and physiology of pain, supported by a biopsychosocial assessment. PNE is increasingly used by physiotherapists for chronic pain management.

Quadriceps weakness contributes to functional decline in KOA. Conventional high-load resistance training may exacerbate joint pain; thus, low- to moderate-intensity training is recommended. Blood flow restriction training (BFRT) partially restricts arterial inflow and occludes venous outflow during low-load exercise, originally developed as "kaatsu training" in Japan. BFRT is used in rehabilitation and performance training across healthy individuals, athletes, older adults, and hypertensive patients. Factors affecting adaptations include occlusion pressure, type (continuous/intermittent), exercise intensity, and volume. Low-load resistance with BFRT reduces joint pain and increases muscle strength and mass in older adults, including those with KOA risk factors.

A systematic review of six RCTs on BFRT in KOA patients showed significant pain improvement in four studies, but meta-analysis did not confirm a significant difference. Combining exercise therapy and education is recommended for musculoskeletal pain reduction; pain education alone reduced healthcare spending by 45% over three years. However, physical therapists underutilize pain management approaches, and knowledge gaps remain barriers.

Controlled clinical studies on BFRT in KOA are lacking. This randomized trial aims to evaluate whether BFRT, PNE, and standard treatment improve pain, function, muscle thickness, and patient satisfaction in KOA patients.

The 3 groups in the trial

  • control groupExisting treatment, for comparison

    All participants will be received conventional TENS (Chattanooga, Intellect Advanced, USA) and exercises

    Treatment: Standard Treatment, Pain neuroscience education, and Blood flow restriction training

  • Pain neuroscience education groupTreatment being tested

    The PNE will include five dimensions with a focus on reducing fear-avoidance beliefs and catastrophic thoughts to promote self-efficacy. This educational session will be provided only by one therapist to all the participants. The session includes a verbal explanation with a visual presentation on PowerPoint with a duration of 30-45 minutes. Educational content of the session will include pictures, examples, and metaphors for explaining pain. The metaphorical alarm system will be used to describe the nervous system's sensitivity. plus the standard treatment given to the control group.

    Treatment: Pain neuroscience education

  • Blood flow restriction trainingTreatment being tested

    The participant will receive the same intervention of control group in addition to Blood flow restriction training. For blood flow restriction, a 10 cm cuff (Theratool, China) will be placed around the most proximal portion of the exercising leg (around the bulk of the quadriceps). While the subject is seated on a chair, the pressure cuff will be inflated to 120 mmHg for 30 seconds, then deflated. The pressure cuff will then be inflated four more times, with each period increased by 20 mmHg. Each period lasted 30 seconds, and the cuff was released for 10 seconds between periods until a final pressure of 200 mmHg was reached. With the pressure maintained at 200 mmHg, the subjects then will perform a four set of leg extension exercises (75 repetitions across four sets of exercises, with 30 repetitions in the first set and 15 repetitions in each subsequent set) at the final exercise pressure, the exercise loads will be set between 20 and 40% of 1RM,for three time per week /8weeks

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Impact of Blood-flow-restricted Exercise Training and Pain Education on Pain, Function, Muscle Thickness, and Self-satisfaction in Patients With Knee Osteoarthritis.
Plain-language title
Blood flow restriction exercise and pain education for knee osteoarthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07590323, who can take part
Record updated
10 September 2026