Intra-Articular Use of Platelet Rich Plasma Versus Corticosteroid: A Clinical Trials in Osteoarthritis of Knee.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Change in pain
研究概览
简要总结
Osteoarthritis of the knee is a very prevalent disease. However, there are few therapeutic options for its patients. Platelet-rich plasma is a treatment option for chronic pain. If proven to be effective in its intra-articular use, Platelet-rich plasma may help in the treatment of these patients.
Goal:
Primary objective: To compare effectiveness in improving pain and function and the medium-term tolerance (12 weeks) of intra-articular injection of Platelet-rich plasma versus intraarticular injection of triamcinolone hexacetonide in patients with symptomatic primary knee osteoarthritis.
Secondary objective: To compare the medium-term effectiveness of intra-articular injection of Platelet-rich plasma versus intra-articular injection of triamcinolone hexacetonide to improve synovial hypertrophy and quality of life in these patients.
Methods: A prospective randomized controlled double-blind study with three groups (each with n = 33) of patients with symptomatic osteoarthritis of knees who will receive intra-articular infiltration in a single moment. Patients will be allocated to one of three groups: 1) Platelet-rich plasma group: patients who will receive plasma; 2) triamcinolone hexacetonide Group: patients who will receive 40mg of triamcinolone hexacetonide; And 3) Isotonic saline solution group: patients who will receive isotonic saline solution. The patients will be evaluated by "blind" evaluators in 4 assessment times up to 12 weeks of follow-up through clinical assessment instruments (rest and movement pain, joint edema, goniometry, clinical improvement scale, quality of life questionnaire as the SF36), functional (Womac questionnaire, M. Lequesne Functional Knee Index, 6 min walk test, Time up and go test), and ultrasound test (quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler).
Statistics: The following statistical tests will be used according to the need: Student's t test, Mann-whitney, Pearson's chi-square test and ANOVA for repeated measures. A statistical significance of 5% will be considered.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary knee osteoarthritis
- •degree II and II in Kellgren & Lawrence classification
- •pain duration: more than three months
- •pain in the visual analogue scale between 4 and 8cm
- •agree in participate and sign the consent form
排除标准
- •secondary knee osteoarthritis
- •skin lesion in knee
- •intraarticular joint injection in the previous three months
- •steroids use in the previous 30 days
- •degree I or IV in Kellgren & Lawrence classification
- •inflammatory arthritis, gout and pseudo-gout
- •previous surgery in knee
- •cardiovascular and respiratory disease that change functional status
- •pregnancy and breastfeed
- •coagulation disturb
- •bacterial infection
- •handicapped
- •NSAIDs and Platelet anticoagulant in the previous month
研究组 & 干预措施
Platelet rich plasm group
干预措施: platelet rich plasm (Procedure)
Triamcinolone Hexacetonide group
干预措施: Triamcinolone Hexacetonide (Drug)
Isotonic Saline Solution group
干预措施: Isotonic Saline Solution (Procedure)
结局指标
主要结局
Change in pain
时间窗: Baseline, after 4, 8, 12 and 48 weeks
Evaluated using a visual analogue scale
次要结局
- Change in functional capacity(Baseline, after 4, 8, 12 and 48 weeks)
- Change in joint edema(Baseline, after 4, 8, 12 and 48 weeks)
- Change in range of motion(Baseline, after 4, 8, 12 and 48 weeks)
- Change in a clinical improvement scale(Baseline, after 4, 8, 12 and 48 weeks)
- Change in quality of life(Baseline, after 4, 8, 12 and 48 weeks)
- Changing in quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler(Baseline, after 4, 8, 12 and 48 weeks)
研究者
Jose Carlos Nunes Tamashiro
Principal Investigator
Federal University of São Paulo