BFR Training and Knee Osteoarthritis
ConditionKnee Osteoarthristis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorUniversity of Hail
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Treatment
Other intervention1. 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
Pain neuroscience education
Other interventionPain 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.
Blood flow restriction training
Other interventionFor 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
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: control groupActive comparator 3 interventions
Group B: Pain neuroscience education groupExperimental treatment 1 intervention
Group C: Blood flow restriction trainingExperimental treatment 1 intervention
Trial outcomes
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
Time frame
at baseline, after 4 weeks of intervention program, and after 2 months follow upSecondary outcomes
1
Pain catastrophizing by Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) is a 13-item self-report questionnaire used to measure the degree to which individuals both in clinical and research settings experience negative cognitive-emotional responses to actual or anticipated pain. It assesses three dimensions: rumination, magnification, and helplessness, The validity and reliability of the Arabic version of PCS has been previously confirmed
Time frame
at baseline, after 4 weeks of interventions, and after 2 months follow up2
Kinesiophobia by tampa scale of kinesiophobia
Kinesiophobia. Tampa Scale for Kinesiophobia (TSK) contains 17 items related to fear of movement and reinjury. The score ranges from 17 to 68 (scores ≤ 37 presenting low fear and scores \> 37 presenting high fear of movement), The validty and reliability of the Arabic version of Kinesiophobia. Tampa Scale was confirmed.
Time frame
at baseline, after 4 weeks of interventions, and after 2 months follow up3
Muscle thickness (MT) measured by ultrasound
Muscle thickness will be assessed from images obtained in vivo at rest using B-mode ultrasonography. MT has previously been assessed by placing the ultrasound probe transversally in relation to the limb and evaluated as the perpendicular distance between the skeletal muscle interfaces. Longitudinal ultrasound scans (ie, with the probe aligned with the fascicle plane) have also been used to detect changes in muscle size and growth as well as skeletal muscle architecture.
Time frame
at baseline, after 4 weeks of intervention, and after 2 months follow up4
Knee Injury and Osteoarthritis Function
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-administered questionnaire designed to assess patients' opinions of their knee and related problems. It consists of 42 items categorized into five subscales: pain (9 items), symptoms (7 items), activities of daily living (17 items), sports (5 items), and quality of life (QoL) (4 items). Each item is rated from 0 (none) to 4 (extreme). Each subscale is assessed separately, ranging from 0 (extremely difficult) to 100 (optimal state)(40), The KOOS demonstrates reliability and validity for evaluating the course of knee injury and treatment outcomes. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Time frame
at baseline, after 4 weeks of intervention, and after 2 months follow upSponsors and contacts
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Source ClinicalTrials.gov