Knee OsteoarthristisNCT07590323
BFR Training and Knee Osteoarthritis
A study testing Standard Treatment, Pain neuroscience education and Blood flow restriction training in people with Knee Osteoarthristis, run by University of Hail at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Standard Treatment, Pain neuroscience education and Blood flow restriction training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Jun 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
University of Hail
Ha'il, Ha'il Region, 3994
Hisham Hussein, PhD, 0543704108, hm.hussein@uoh.edu.sa
About this study
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.
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.
Read more
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.
Read the detailed description
KOA is a chronic, progressive, and severe degenerative joint disease marked by the slow degeneration of articular cartilage and subchondral bone, synovial inflammation, and structural changes in the meniscus and ligaments. Clinically, it is characterized by chronic knee pain, morning stiffness, swelling, crepitus, and a restricted range of motion (ROM). These signs and symptoms frequently result in functional impairment, gait abnormalities, and a significant decline in quality of life.
KOA is a common degenerative disease characterized by joint swelling, discomfort, stiffness, functional impairments, severe muscle atrophy, and even incapacity. According to statistics, KOA affects an estimated 302 million people worldwide. In Saudi Arabia, the prevalence of knee osteoarthritis (KOA) rises from 30.8% in those aged 46-55 to over 60% in those aged 66-75. KOA is particularly common in older, female, and obese people. The condition is strongly correlated with high BMI, inactivity, and aging. It frequently results in severe discomfort and restricted movement.
This syndrome is becoming more prevalent as the population ages and physical fitness declines; it imposes a greater health burden on individuals and has a substantial impact on the healthcare system and socioeconomic expenditures.
According to the International Classification of Functioning, Disability, and Health (ICF), KOA leads to activity limitations and participation restrictions as well as impairment. It is one of the leading causes of physical disability among the general population. In addition to causing considerable impairment, this condition results in a notable decrease in quality of life due to pain, limited range of motion, and loss of muscle strength.The Key risk factors of KOA include aging, gender differences (women more than men), obesity, previous knee injuries, and genetic factors.
Besides pharmacological treatments, physical therapy intervention such as (education, exercise, and weight loss) are crucial for managing KOA subjects, The effectiveness of such treatments depends on the patient's willingness to change their behavior, which can be difficult to achieve.
Due to scientific advances in pain treatment and rising rates of chronic pain prevalence, the traditional biomedical educational model was unable to adequately address pain. In pain science education, the process of teaching the underlying biology and physiology of pain is known as pain neuroscience education (PNE).Physiotherapists increasingly use PNE in the treatment of chronic pain patients. PNE should be preceded by a comprehensive biopsychosocial assessment in order to evaluate pain neurophysiology and biopsychosocial interactions and give the patient a voice in this process.
Functional decline in KOA patients is associated with quadriceps weakness. In conventional interventions to strengthen muscles, high-load or high-intensity resistance training is commonly used. Adults with KOA are recommended to perform low- to moderate-intensity resistance training to improve muscle strength and limit joint pain.
Blood flow restriction training (BFRT) involves partially restricting arterial blood flow into muscles as well as occluding the venous outflow during exercise. It was first introduced into the literature by Japanese doctor called Yoshiaki Sato in Japan in 1987 who used tourniquet ischemia to induce muscle fatigue. This technique was originally called "kaatsu training," meaning "training with added pressure." Kaatsu training is now performed all over the world and is more commonly referred to as "BFRT" and achieved using a pneumatic tourniquet system.
In addition to physical rehabilitation, BFRT is used for physical training and performance in healthy individuals. There has been extensive research into its value as a training tool, including elite- and amateur-level athletes, untrained young and older adults, and hypertensive individuals.
There were different Factors affecting exercise adaptations with BFR including pressure of occlusion (partial or complete), type of occlusion (continuous or intermittent), intensity of exercise, and volume of exercise with BFR.
The combination of low-load resistance training with BFRT may help to reduce training related joint pain. In BFRT training, the exercising limb is compressed externally and blood flow is mildly restricted to the activated skeletal muscle. It has been independently validated that BFRT resistance training can increase skeletal muscle strength and mass in older adults, especially those with risk factors for knee osteoarthritis.
The results of Gama Linhares and colleague's systematic review, which was done on six RCTs included in this meta-analysis, four studies showed a significant improvement in pain with the use of the BFRT in KOA patients (p < 0.05). However, the results of the meta-analysis did not confirm this significant difference.
A combination of exercise therapy and education was recommended as the most effective intervention for reducing musculoskeletal pain. In addition, using pain education alone reduced health care spending by 45% over three years. Pain management approaches don't seem to be widely used by physical therapists in clinical settings. Moreover, pain management prescriptions are lacking in knowledge, making pain a bigger barrier in areas where knowledge is lacking. It is therefore important to emphasize the importance of education and effective therapeutic exercise(s).
To our knowledge, controlled clinical studies investigating the effect of BFRT in KOA subjects are currently lacking. Therefore, the current randomized trial aims to examine whether interventions of BFRT, PNE, with standard treatment can serve as an effective method for improving pain, function, muscle thickness, and patient satisfaction in patients with KOA.
- Conditions
- Knee Osteoarthristis
- Being tested
- Standard Treatment, Pain neuroscience education, Blood flow restriction training
- Keywords
- osteoarthritis; blood flow restrriction; muscles; pain; function
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard TreatmentOther
- 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.
- Exercise training
- Hamstrings stretching, 3 repetitions of 30 s ,
- Hip abduction with weights (side lying), 3 sets of 10 repetitions Hip abduction with weights (side lying), 3 sets of 10 repetitions
- Calf raises, 3 sets of 10 repetitions
- Calm exercises (side lying) with elastic band, 3 sets of 10 repetitions+
- Seated knee extension (machine), 90°-0° of knee flexion, 3 sets of 10 repetit
Pain neuroscience educationOther
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.
Blood flow restriction trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | All participants will be received conventional TENS (Chattanooga, Intellect Advanced, USA) and exercises Receives: 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. Receives: 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 Receives: Other: Blood flow restriction training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline, after 4 weeks of intervention program, and after 2 months follow up
Secondary outcomes (5)
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
Measured: at baseline, after 4 weeks of interventions, and after 2 months follow up
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.
Measured: at baseline, after 4 weeks of interventions, and after 2 months follow up
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.
Measured: at baseline, after 4 weeks of intervention, and after 2 months follow up
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.
Measured: at baseline, after 4 weeks of intervention, and after 2 months follow up
Lower limb mobility by Time up and go test (TUG)
The 'timed up and go' test (TUG) is a simple, quick, and widely used clinical performance-based measure of lower extremity function, mobility, and fall risk among older adults. TUG is a valid and reliable test; subjects are asked to stand from a standard chair, walk a distance of 3 meters (marked on the floor) at a comfortable pace, turn, walk back, and sit down; all subjects are allowed to use routine walking aids, but are forbidden from using their arms to stand up, There is no physical assistance provided, A stopwatch is used to measure the time it takes to complete the task, Upon receiving the command 'go,' timing begins and stops when the subject's back is positioned against the back of the chair, The time needed to perform the task was recorded in seconds. Interpretation: < 10 seconds = normal, < 20 seconds = good mobility, can go out alone, mobile without a gait aid., < 30 seconds = problems, cannot go outside alone, requires a gait aid.
Measured: at baseline, after 4 weeks of interventions, and after 2 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start15 Jun 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, three-arm, parallel-group, assessor-blinded randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hail
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Mohamed Hussein, University of Hail
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590323
- Sponsor's protocol ID
- H-2026-143
- Status last verified
- Sep 2026
- First submitted
- 9 May 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will be used for other future research projects
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07590323
- Acronym / sponsor ID
- H-2026-143
- Conditions
- Knee Osteoarthristis
- Keywords
- osteoarthritis; blood flow restrriction; muscles; pain; function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of HailUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
KOA is a chronic, progressive, and severe degenerative joint disease marked by the slow degeneration of articular cartilage and subchondral bone, synovial inflammation, and structural changes in the meniscus and ligaments. Clinically, it is characterized by chronic knee pain, morning stiffness, swelling, crepitus, and a restricted range of motion (ROM). These signs and symptoms frequently result in functional impairment, gait abnormalities, and a significant decline in quality of life.
KOA is a common degenerative disease characterized by joint swelling, discomfort, stiffness, functional impairments, severe muscle atrophy, and even incapacity. According to statistics, KOA affects an estimated 302 million people worldwide. In Saudi Arabia, the prevalence of knee osteoarthritis (KOA) rises from 30.8% in those aged 46-55 to over 60% in those aged 66-75. KOA is particularly common in older, female, and obese people. The condition is strongly correlated with high BMI, inactivity, and aging. It frequently results in severe discomfort and restricted movement.
This syndrome is becoming more prevalent as the population ages and physical fitness declines; it imposes a greater health burden on individuals and has a substantial impact on the healthcare system and socioeconomic expenditures.
According to the International Classification of Functioning, Disability, and Health (ICF), KOA leads to activity limitations and participation restrictions as well as impairment. It is one of the leading causes of physical disability among the general population. In addition to causing considerable impairment, this condition results in a notable decrease in quality of life due to pain, limited range of motion, and loss of muscle strength.The Key risk factors of KOA include aging, gender differences (women more than men), obesity, previous knee injuries, and genetic factors.
Besides pharmacological treatments, physical therapy intervention such as (education, exercise, and weight loss) are crucial for managing KOA subjects, The effectiveness of such treatments depends on the patient's willingness to change their behavior, which can be difficult to achieve.
Due to scientific advances in pain treatment and rising rates of chronic pain prevalence, the traditional biomedical educational model was unable to adequately address pain. In pain science education, the process of teaching the underlying biology and physiology of pain is known as pain neuroscience education (PNE).Physiotherapists increasingly use PNE in the treatment of chronic pain patients. PNE should be preceded by a comprehensive biopsychosocial assessment in order to evaluate pain neurophysiology and biopsychosocial interactions and give the patient a voice in this process.
Functional decline in KOA patients is associated with quadriceps weakness. In conventional interventions to strengthen muscles, high-load or high-intensity resistance training is commonly used. Adults with KOA are recommended to perform low- to moderate-intensity resistance training to improve muscle strength and limit joint pain.
Blood flow restriction training (BFRT) involves partially restricting arterial blood flow into muscles as well as occluding the venous outflow during exercise. It was first introduced into the literature by Japanese doctor called Yoshiaki Sato in Japan in 1987 who used tourniquet ischemia to induce muscle fatigue. This technique was originally called "kaatsu training," meaning "training with added pressure." Kaatsu training is now performed all over the world and is more commonly referred to as "BFRT" and achieved using a pneumatic tourniquet system.
In addition to physical rehabilitation, BFRT is used for physical training and performance in healthy individuals. There has been extensive research into its value as a training tool, including elite- and amateur-level athletes, untrained young and older adults, and hypertensive individuals.
There were different Factors affecting exercise adaptations with BFR including pressure of occlusion (partial or complete), type of occlusion (continuous or intermittent), intensity of exercise, and volume of exercise with BFR.
The combination of low-load resistance training with BFRT may help to reduce training related joint pain. In BFRT training, the exercising limb is compressed externally and blood flow is mildly restricted to the activated skeletal muscle. It has been independently validated that BFRT resistance training can increase skeletal muscle strength and mass in older adults, especially those with risk factors for knee osteoarthritis.
The results of Gama Linhares and colleague's systematic review, which was done on six RCTs included in this meta-analysis, four studies showed a significant improvement in pain with the use of the BFRT in KOA patients (p < 0.05). However, the results of the meta-analysis did not confirm this significant difference.
A combination of exercise therapy and education was recommended as the most effective intervention for reducing musculoskeletal pain. In addition, using pain education alone reduced health care spending by 45% over three years. Pain management approaches don't seem to be widely used by physical therapists in clinical settings. Moreover, pain management prescriptions are lacking in knowledge, making pain a bigger barrier in areas where knowledge is lacking. It is therefore important to emphasize the importance of education and effective therapeutic exercise(s).
To our knowledge, controlled clinical studies investigating the effect of BFRT in KOA subjects are currently lacking. Therefore, the current randomized trial aims to examine whether interventions of BFRT, PNE, with standard treatment can serve as an effective method for improving pain, function, muscle thickness, and patient satisfaction in patients with KOA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, three-arm, parallel-group, assessor-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Standard Treatment, Other: Pain neuroscience education, Other: Blood flow restriction trainingAll participants will be received conventional TENS (Chattanooga, Intellect Advanced, USA) and exercises |
| Pain neuroscience education group | Experimental | Other: Pain neuroscience educationThe 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. |
| Blood flow restriction training | Experimental | Other: Blood flow restriction trainingThe 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 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Treatment1. 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 | Other | control group |
| Pain neuroscience educationPain 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. | Other | Pain neuroscience education group, control group |
| Blood flow restriction trainingFor 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, control group |
Primary outcome
Pain by the numeric pain rating scale
Time frame: at baseline, after 4 weeks of intervention program, and after 2 months follow up
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
5 secondary outcomes
Pain catastrophizing by Pain Catastrophizing Scale (PCS)
Time frame: at baseline, after 4 weeks of interventions, and after 2 months follow up
Kinesiophobia by tampa scale of kinesiophobia
Time frame: at baseline, after 4 weeks of interventions, and after 2 months follow up
Muscle thickness (MT) measured by ultrasound
Time frame: at baseline, after 4 weeks of intervention, and after 2 months follow up
Knee Injury and Osteoarthritis Function
Time frame: at baseline, after 4 weeks of intervention, and after 2 months follow up
Lower limb mobility by Time up and go test (TUG)
Time frame: at baseline, after 4 weeks of interventions, and after 2 months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. will be used for other future research projects
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Treatment, Pain neuroscience education and Blood flow restriction training in people with Knee Osteoarthristis, run by University of Hail at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hisham Hussein, PhD (+20543704108, hm.hussein@uoh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain by the numeric pain rating scale (time frame: at baseline, after 4 weeks of intervention program, and after 2 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.