Efficacy Of Platelet Rich Plasma In The Treatment Of Hemiplegıc Shoulder Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Visual Analogous Scale
研究概览
简要总结
In this study assessing whether platelet rich plasma injections(PRP) are effective in the management hemiplegic shoulder pain, 55 patients with hemiplegic shoulder pain was recruited to this randomized controlled study. Patients were randomized into two groups, first getting PRP injections, and other group taking sham injections.
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 (Participant, Care Provider, Outcomes Assessor)
盲法说明
Solutions were prepared by an investigator, and injectors were coated with an opaque layer in order to conceal the content from both the one performing the injection and the patients. Data was then analyzed by an investigator who was blind to the study groups
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria were being an adult stroke patient with more than two weeks of shoulder pain and restriction, and not having a history of stroke before the recent incident.
排除标准
- •Patients with aphasia, severe cognitive or psychiatric disorders, history of trauma, recent injection (<3 months) or surgery on the affected joint, complex regional pain syndrome, infections, pregnancy, thrombocytopenia(<150000 per microliter) or coagulation disorders or severe spasticity of the affected limb(Modified Ashworth Scale >3) were excluded from the study
研究组 & 干预措施
PRP group
A venous blood sample of 8.5 ml were obtained from patients. For the study group, the blood samples were mixed with 1.5 ml ACD-A or sodium citrate to achieve anticoagulation. Resulting material was then centrifugated for 5 minutes with RCF 1200 G speed to clump erythrocytes, and then centrifugated for 10 minutes in same speed to obtain thrombocyte concentrate. 2 ml's of the platelet rich plasma was injected to the shoulder of the subjects. For the sham injection group, same amount of blood was taken and they were given a of waiting time of same duration with the study group, with the resulting preparate being 2 ml's of 0,9% saline instead. PRP solutions were prepared with kits of Easy PRP(Neotec Biotechnology, Istanbul, Turkey).
Injections were done every two weeks, for a total of 3 times.
干预措施: Exercise (Other)
Placebo group
Injections containing saline were done every two weeks, for a total of 3 times. 21 G injection needles with injection technique of posterior approach were used. To provide blindness, all injections were done using injectors coated with non transparent tape. All of the PRP injections were done by the same physician each time, with compliance to preventive measures against complications such as infections. Patients and the physician who applied the injection were blinded to the groups, and the solution was prepared by another researcher who was not blind to the groups.
干预措施: Exercise (Other)
PRP group
A venous blood sample of 8.5 ml were obtained from patients. For the study group, the blood samples were mixed with 1.5 ml ACD-A or sodium citrate to achieve anticoagulation. Resulting material was then centrifugated for 5 minutes with RCF 1200 G speed to clump erythrocytes, and then centrifugated for 10 minutes in same speed to obtain thrombocyte concentrate. 2 ml's of the platelet rich plasma was injected to the shoulder of the subjects. For the sham injection group, same amount of blood was taken and they were given a of waiting time of same duration with the study group, with the resulting preparate being 2 ml's of 0,9% saline instead. PRP solutions were prepared with kits of Easy PRP(Neotec Biotechnology, Istanbul, Turkey).
Injections were done every two weeks, for a total of 3 times.
干预措施: PRP (Other)
结局指标
主要结局
Visual Analogous Scale
时间窗: 3 months
Visual Analogous Scales for pain were used as outcome measures. Both resting and activity pain levels were evaluated. Patients were asked to describe their pain, level of disability or treatment satisfaction on a 10 cm long line, with 0 point being "none", and 10 cm point being "highest possible". The proximity of the marked point to the 0 end was measured, and the results were recorded
次要结局
- Shoulder ranges of motion(3 months)
- Functional Independence Measure(FIM)(3 months)
研究者
Hale Karapolat
Professor in Physical Medicine and Rehabilitation Department
Ege University