Evaluating the Role of Intra-articular Injections of Platelet-rich Plasma (PRP) in Patients With Rheumatoid Arthritis and Its Impact on Disease Activity and Quality of Life.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- visual analogue scale (VAS).
研究概览
简要总结
To evaluate the therapeutic effect of 3 local doses of PRP intra-articular injection in patients with RA regarding the improvement of disease activity and quality of life versus placebo.
详细描述
100 patients with RA fulfilling the 2010 ACR-EULAR classification criteria for RA were recruited from the outpatient clinic of the Rheumatology and Rehabilitation department. All patients were subjected to clinical and laboratory assessment, visual analog score (VAS) scale and Health Assessment Questionnaire (HAQ). Fifty patients were injected intra-articularly with 3 doses of PRP and 50 patients who serve as a control injected with 3 doses of placebo at 4 weeks intervals for the tender joints and revaluated at 1, 3 months post the last injection regarding the same evaluating tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed as RA regarding 2010 new criteria of RA, both sex,aged20-60 years old.
排除标准
- •Patients with Local abscess,
- •systemic illness as (diabetes mellitus, malignancy),
- •patients on opioids analgesics.
- •pregnancy, blood disorders(coagulopathy, thrombocytopenia),
结局指标
主要结局
visual analogue scale (VAS).
时间窗: Change from baseline to 6 months post injection.
the pain severity determined by the patients on scale of 0(no pain) to 10 (Agonizing pain)
Inflammatory mediators.
时间窗: Change from baseline to 6 months post injection.
By means of ELISA (IL 1 beta and TNF alpha
Health assessment questionnaire disability index. (HAQ-DI)
时间窗: Change from baseline to 6 months post injection.
Is a patient reported outcome which is usually self-administered by the patient and scales range from 0 (no difficulty) to 3 (unable to do)
次要结局
- Disease Activity Score 28(DAS28)(At baseline,3 and 6 months post injection.)
研究者
Dalia Salah Saif
principle investigator
Menoufia University