Influence of Perception of Patients Suffering of Osteoarthritis of Knee Over the Effectiveness and Tolerance in Intra-articular Injection of Corticoids: a Prospective, Controlled and Randomized Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 主要终点
- Change on pain
研究概览
简要总结
Introduction; reception must be understood as the offered attention within the relationship between a healthcare worker and the patient, including attitudes of inclusion, hearing, valorization of complains and identification of needs, being these individual collective. As a part of this process, communication is a primary and indispensable toll through which the healthcare team and the patient interchange information.
Objective: to evaluate the influence of perception of patients suffering of knee osteoarthritis over fear, catastrophizing of pain and effectiveness, related to intra-articular injection od corticosteroids.
Material and method: it will be performed a prospective, controlled and randomized study eith a blind evaluator on patients with symptomatic knee osteoarthritis submitted to joint injection. A hundred patients suffering of symptomatic knee osteoarthritis coming from the outpatient area of Rheumatology Division of Federal University of Sao Paulo (UNIFESP) will be evaluated, 50 belonging to the intervention group (reception) and 50 to a control group.
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 (Investigator)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •knee osteoarthritis according to american college of rheumatology criteria
- •no previous experience of joint injection
- •stable use of drugs for osteoarthritis treatment for at least 3 months
- •stable dose of corticosteroids, non hormonal anti-inflammatory and analgesics in the previous month
- •pain on knee between 3 and 7 in the visual analogue scale
- •signe the informed consent term
- •radiologic classification between 1-3 (kellgren and Lawrence classification)
排除标准
- •joint disease of different etiology
- •coagulation alteration
- •non treated fibromyalgia
- •litigation
- •diabetes mellitus and systemic arterial hypertension out of control
- •allergy of lidocaine or triamcinolone hexacetonide
研究组 & 干预措施
Intervention Group
Patients will receive the reception treatment before the joint injection
干预措施: Reception (Procedure)
Intervention Group
Patients will receive the reception treatment before the joint injection
干预措施: Joint injection with triamcinolone hexacetonide (Drug)
Control Group
patient will receive a joint injection
干预措施: Joint injection with triamcinolone hexacetonide (Drug)
结局指标
主要结局
Change on pain
时间窗: baseline, after 1, 4 and 12 weeks
Pain will be evaluated with an visual analogue scale
次要结局
- Change on functional capacity(baseline, after 1, 4 and 12 weeks)
- Change on Catastrophizing(baseline, after 1, 4 and 12 weeks)
研究者
Sandra Regina Toffolo
Principal Investigator
Federal University of São Paulo