Effects of Including a Chronic Pain Neuroscience Education Program for Individuals With Knee OA: Randomized, Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Functional disability
研究概览
简要总结
Research participants diagnosed with knee osteoarthritis will be randomized through a draw using sealed opaque envelopes indicating two groups: 1. therapeutic exercises, 2. therapeutic exercises + chronic pain neuroscience education program. The primary outcome will be functional performance using a patient-reported measure, the Knee Injury and Osteoarthritis Outcome Score (KOOS).
The selected secondary outcomes will be pain intensity by the numerical pain scale (END), physical function reported by the patient by the patient-specific functional scale (EFEP), Pain self-efficacy questionnaire (PSEQ), functional mobility by the timed up and test (TUG), general effect perceived through the global perception scale (EPG), muscle strength through Maximum Voluntary Isometric Contraction (MVIC) and functionality and disability through the World Health Organization Disability Assessment Schedule (WHODAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of knee osteoarthritis (knee pain for > 3 months
- •Morning stiffness <30 minutes
- •Bone tenderness, and absence of palpable heat and/or diagnosis established radiographically (determined by Kellgren and Lawrence grade 1 to 3 on a scale 1 up to 4)
排除标准
- •severe osteoporosis
- •Fibromyalgia
- •Medical history of tumors or cancer
- •Active inflammatory joint diseases (rheumatoid arthritis, gout)
- •Undergoing any lower extremity joint replacement
- •Neurological diseases (Parkinson's disease, stroke, Multiple Sclerosis, muscular dystrophy, motor neuron disease, Alzheimer's disease, cognitive and cardiopulmonary impairment that may prevent or limit the performance of exercises, use of a gait assistance device, history of recent knee trauma.
- •Having undergone any form of treatment involving physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotective in the last six months
研究组 & 干预措施
Therapeutic exercise group
The therapeutic exercise program will include warm-up, resistance, neuromuscular, mobility, and balance exercises. Over ten weeks, two sessions of the therapeutic exercise program will be carried out individually, lasting approximately 60 minutes each-a total of 20 therapeutic exercise sessions. Therapeutic exercise sessions will be carried out at least 24 hours between sessions. The therapeutic exercises will be performed in up to three sets of 8-12 repetitions or 30-60 seconds each, with rest intervals of 90 seconds between sets.
干预措施: Therapeutic exercises (Other)
Therapeutic exercise group and pain neuroscience education program
The therapeutic exercise program will include warm-up, resistance, neuromuscular, mobility, and balance exercises. Over ten weeks, two sessions of the therapeutic exercise program will be carried out individually, lasting approximately 60 minutes each-a total of 20 therapeutic exercise sessions. Therapeutic exercise sessions will be carried out at least 24 hours between sessions. The therapeutic exercises will be performed in up to three sets of 8-12 repetitions or 30-60 seconds each, with rest intervals of 90 seconds between sets. The chronic pain neuroscience education program will be based on three domains. Making sense of pain, exposure with control, and lifestyle changes.
干预措施: Therapeutic exercises (Other)
Therapeutic exercise group and pain neuroscience education program
The therapeutic exercise program will include warm-up, resistance, neuromuscular, mobility, and balance exercises. Over ten weeks, two sessions of the therapeutic exercise program will be carried out individually, lasting approximately 60 minutes each-a total of 20 therapeutic exercise sessions. Therapeutic exercise sessions will be carried out at least 24 hours between sessions. The therapeutic exercises will be performed in up to three sets of 8-12 repetitions or 30-60 seconds each, with rest intervals of 90 seconds between sets. The chronic pain neuroscience education program will be based on three domains. Making sense of pain, exposure with control, and lifestyle changes.
干预措施: Therapeutic exercises + pain neuroscience education program (Other)
结局指标
主要结局
Functional disability
时间窗: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
Knee Injury and Osteoarthritis Outcome Score (KOOS). It aims to evaluate the domains of pain, symptoms, activities of daily living, function related to recreation and sports, and quality of life related to the knee. Totaling 42 items, each item must be answered using a Likert scale that ranges from 0 (best score) to 4 (worst score), and the score for each subscale ranges from 0 (worst score) to 100 (best score).
次要结局
- Numerical Pain Scale(Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.)
- Global Perception of Change scale(Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.)
- Maximum voluntary isometric contraction(Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.)
- Dynamic balance(Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.)
- Functional self-perception(Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.)
- Self-perceived functionality(Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.)
- Functionality(Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.)
研究者
Cid André Fidelis de Paula Gomes
Principal Investigator
University of Nove de Julho