| NCT ID | NCT07590323 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Hail |
| Condition | Knee Osteoarthristis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2026-06-15 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07590323 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 70 Years, studying Knee Osteoarthristis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07590323 currently recruiting?
Yes, NCT07590323 is actively recruiting participants. Contact the research team at hm.hussein@uoh.edu.sa for enrollment information.
Where is the NCT07590323 trial being conducted?
This trial is being conducted at Ha'il, Saudi Arabia.
Who is sponsoring the NCT07590323 clinical trial?
NCT07590323 is sponsored by University of Hail. The trial plans to enroll 90 participants.