The Impact of Blood-flow-restricted Exercise Training and Pain Education on Pain, Function, Muscle Thickness, and Self-satisfaction in Patients With Knee Osteoarthritis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Pain by the numeric pain rating scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
control group
All participants will be received conventional TENS (Chattanooga, Intellect Advanced, USA) and exercises
干预措施: Pain neuroscience education (Other)
control group
All participants will be received conventional TENS (Chattanooga, Intellect Advanced, USA) and exercises
干预措施: Blood flow restriction training (Other)
Pain neuroscience education group
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.
干预措施: Pain neuroscience education (Other)
Blood flow restriction training
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
干预措施: Blood flow restriction training (Other)
control group
All participants will be received conventional TENS (Chattanooga, Intellect Advanced, USA) and exercises
干预措施: Standard Treatment (Other)
结局指标
主要结局
Pain by the numeric pain rating scale
时间窗: 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
次要结局
- 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)
研究者
Hisham Mohamed Hussein
Professor
University of Hail