NCT05286775已完成不适用
The Functional Treatment of Disabling Pain in Knee Osteoarthritis in a Rehabilitation Program for the Brazilian Unified Health System
Marta Imamura2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2022年3月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Knee function
研究概览
简要总结
This is a Randomized Clinical Trial to compare two interventions for reducing knee pain and improving knee function of patients with knee osteoarthritis.
Sixty participants will be randomly allocated to one of the intervention groups, either a knee educational program or a combination of knee educational program and medical interventions.
Participants will be assessed primarily on function and pain, as well as other secondary outcomes at baseline, at the end of the interventions, and three months after the end of the interventions.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of knee osteoarthritis;
- •Moderate to severe knee pain (VAS >= 4);
- •Knee pain for at least 3 months prior to inclusion;
- •Willing to sign the Informed Consent Form.
排除标准
- •Untreated severe psychological or psychiatric diseases without treatment;
- •Presence of fibromyalgia;
- •Presence of systemic inflammatory rheumatic diseases;
- •Presence of neoplasia;
- •Presence of relevant pain in other joints, according to medical evaluation;
- •Presence of intolerance or allergy to Lidocaine or local anaesthetics;
- •Concomitant use of anticoagulant drug.
结局指标
主要结局
Knee function
时间窗: Baseline and up to six months from baseline.
Change of knee function from baseline measured with Knee Injury and Osteoarthritis Outcome Score (KOOS)
次要结局
- Knee pain as assessed by Visual Analogue Scale (VAS)(Baseline, up to three months from baseline, and up to six months from baseline.)
- Gait analysis (joint angles)(Baseline and up to three months from baseline.)
- Knee function(Baseline and up to three months from baseline.)
- Physical activity level(Baseline, up to three months from baseline, and up to six months from baseline.)
- Pain pressure threshold(Baseline, end of treatment, and three months from end of treatment.)
- Quality of Life Assessment as assessed by the 36-Item Short-Form Health Survey (SF-36)(Baseline, up to three months from baseline, and up to six months from baseline.)
- Pain modulation(Baseline, up to three months from baseline, and up to six months from baseline.)
- Bio-mechanical assessment (Steps)(Baseline, up to three months from baseline, and up to six months from baseline.)
- Bio-mechanical assessment (Energy Expenditure)(Baseline, up to three months from baseline, and up to six months from baseline.)
- Bio-mechanical assessment (Physical activity intensity)(Baseline, up to three months from baseline, and up to six months from baseline.)
- Gait analysis (gait cycle)(Baseline and up to three months from baseline.)
- Bio-mechanical assessment (Step velocity)(Baseline, up to three months from baseline, and up to six months from baseline.)
- Muscle strength (Work)(Baseline, up to three months from baseline, and up to six months from baseline.)
- Muscle strength (Agonist/Antagonist Balance)(Baseline, up to three months from baseline, and up to six months from baseline.)
- Cutaneous temperature(Baseline, up to three months from baseline, and up to six months from baseline.)
- Muscle strength (Power)(Baseline, up to three months from baseline, and up to six months from baseline.)
- Muscle strength (Peak torque)(Baseline, up to three months from baseline, and up to six months from baseline.)
- Functional mobility(Baseline, up to three months from baseline, and up to six months from baseline.)
研究者
Marta Imamura
MD PhD
University of Sao Paulo
研究点 (2)
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