BFR Training and Knee Osteoarthritis

NCT07590323 | Not Yet Recruiting

• 1 other identifier: H-2026-143
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

Knee Osteoarthristis

Keywords

osteoarthritis; blood flow restrriction; muscles; pain; function

Outcome Measures

Primary Outcomes (1)

• Pain by the numeric pain rating scale

  The Numeric Pain Rating Scale (NPRS) is a unidimensional 0-to-10 measure, where 0 denotes "no pain" and 10 signifies "worst imaginable pain." Participants indicated their current pain intensity by choosing the number that best reflected their experience ,Previous investigations have confirmed the NPRS's strong psychometric properties, reporting validity and reliability coefficients of 0.941 and 0.95, respectively

  at baseline, after 4 weeks of intervention program, and after 2 months follow up

Secondary Outcomes (5)

• Pain catastrophizing by Pain Catastrophizing Scale (PCS)

  at baseline, after 4 weeks of interventions, and after 2 months follow up

• Kinesiophobia by tampa scale of kinesiophobia

  at baseline, after 4 weeks of interventions, and after 2 months follow up

• Muscle thickness (MT) measured by ultrasound

  at baseline, after 4 weeks of intervention, and after 2 months follow up

• Knee Injury and Osteoarthritis Function

  at baseline, after 4 weeks of intervention, and after 2 months follow up

• Lower limb mobility by Time up and go test (TUG)

  at baseline, after 4 weeks of interventions, and after 2 months follow up

Study Arms (3)

control group

ACTIVE COMPARATOR

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

Other: Standard Treatment; Other: Pain neuroscience education; Other: Blood flow restriction training

Pain neuroscience education group

EXPERIMENTAL

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.

Other: Pain neuroscience education

Blood flow restriction training

EXPERIMENTAL

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

Other: Blood flow restriction training

Interventions

Standard Treatment OTHER

1. Physical Modalities (TENS, US, and superficial heat) All participants will be received conventional TENS (Chattanooga, Intellect Advanced, USA) with the following parameters: frequency, 100 Hz; pulse duration, 60 ms; amplitude-modulated frequency, 10%; and intensity adjusted to a comfortable tingling sensation. Two electrodes (single channel) were used: the first was placed over the ipsilateral lumbar region, and the second over the popliteal fossa. The duration of the TENS was 20 minutes. 2. Exercise training 1. Hamstrings stretching, 3 repetitions of 30 s , 2. Hip abduction with weights (side lying), 3 sets of 10 repetitions Hip abduction with weights (side lying), 3 sets of 10 repetitions 3. Calf raises, 3 sets of 10 repetitions 4. Calm exercises (side lying) with elastic band, 3 sets of 10 repetitions+ 5. Seated knee extension (machine), 90°-0° of knee flexion, 3 sets of 10 repetit

control group

Pain neuroscience education OTHER

Pain neuroscience education was used before in such cases (knee osteoarthritis). 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. The purpose of this session will be to establish rapport with the participants, highlight the maladaptive nature of chronic pain, emphasize the significance of pain's role in tissue protection, and improve the subjects' understanding of factors that influence pain production.

Pain neuroscience education group; control group

Blood flow restriction training OTHER

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

Blood flow restriction training; control group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hail: lead

Study Sites (1)

University of Hail

Ha'il, Ha'il Region, 3994, Saudi Arabia

Location

MeSH Terms

Conditions

Osteoarthritis; Pain

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Hisham Hussein, PhD

CONTACT

+20543704108; hm.hussein@uoh.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, three-arm, parallel-group, assessor-blinded randomized controlled trial

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)