The Effect of Platelet-Rich Plasma Injection on Pain, Function and Quality of Life in Patients With Hip Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change from baseline Visual Analog Scale (VAS) score at 1-month, 3-month and 6-month
研究概览
简要总结
To evaluate the effect of platelet-rich plasma (PRP) injection on pain, function and quality of life in patients with hip osteoarthritis.
详细描述
After being informed about the study and potential risk, all patients giving written informed consent will undergo study entry.
Each patient received three times intra-articuler injections of PRP under ultrasound guidance, and they were administered once a week.
Baseline: Visual Analog Scale (VAS) including movement, rest and night, the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and SF-36 assessment
1st month: VAS, WOMAC and SF-36 assessment
3rd month: VAS, WOMAC and SF-36 assessment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hip pain VAS > 4
- •Grade 1 and 2 osteoarthritis according to the Kellgren-Lawrence classification
- •No pathologies in the laboratory and coagulation parameters
排除标准
- •Rheumatological disease with hip involvement
- •Systemic active infection
- •Severe cardiovascular disease
- •Malignancy
- •NSAID usage in the last week
- •History of hip joint surgery
- •History of traumatic hip injury
- •Hgb values < 11 gr/dl
- •Platelets values < 150.000 / µl
- •History of bleeding disorder
结局指标
主要结局
Change from baseline Visual Analog Scale (VAS) score at 1-month, 3-month and 6-month
时间窗: Baseline, 1st month, 3rd month, 6th month
The VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 'no pain' and 'worst pain'.
Change from baseline SF-36 score at 1-month, 3-month and 6-month
时间窗: Baseline, 1st month, 3rd month, 6th month
The SF-36 is a 36-item self-report measure of health-related quality of life. It has eight subscales measuring different domains of health-related quality of life: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health . Two component scores are derived from the eight subscales: a physical health component score and a mental health component score. High scores: good quality of life
Change from baseline Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score at 1-month, 3-month and 6-month
时间窗: Baseline, 1st month, 3rd month, 6th month
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores. Higher scores: worse pain, stiffness, and functional limitations.
次要结局
未报告次要终点
研究者
Selda Çiftci
Specialist, Principal investigator
Sisli Hamidiye Etfal Training and Research Hospital