Role of Biological Therapy in Rotator Cuff Tendinopathy. Effectiveness of Plasma Rich in Growth Factors Regarding Functional Capacity and Pain Compared With the Conventional Treatment Using Steroids
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- 15% of change in the score of the UCLA scale
研究概览
简要总结
The overall objective of the study is to assess the effectiveness of the treatment of degenerative rotator cuff tendinopathy using the application of plasma rich in growth factors (PRGF).
Main objective:
To show more effectiveness after 6 months of treatment with PRGF, with an improvement in the reference test of more than 15% compared to the treatment with corticosteroids.
Secondary objective:
- To assess the efficacy of the treatment after 12 months.
- Quantification of platelet levels in patients treated with plasma rich in growth factors and its correlation with the clinical effect.
详细描述
Study Group. PRGF
Blood extraction was performed in the pre-surgical area using a vacuum system. A total of 20 ml of blood (4 samples of 5 ml) per patient was collected in sterile sodium citrate tubes. PRGF was obtained following Anitua's technique. The tubes with citrated blood were centrifuged at 1,800 rpm for 8 min to obtain a concentrate of platelets suspended in plasma, which was separated into three fractions. Pipetting was carried out with extreme care in all steps, particularly in the last fraction where, in order to avoid inflammation, leukocytes present in the lowermost portion of the centrifuged plasma were not aspirated. PRGF was activated by adding calcium chloride 10%,immediately before infiltration. The proportion required for PRGF activation is 50 ml of activator per 1,000 ml of PRGF. Separation of plasma into three fractions and subsequent activation of the fractions for injection was performed in a laminar flow chamber.
Between the collection of blood and its subacromial administration must not exceed 90 minutes to avoid contamination.
Control group: Celestone Cronodose® (bethametasone).
They were given 3 infiltrations of 2 cc of Celestone cronodose® (bethametasone) every 21 days (If necessary, it could be administered after an application of a small quantity of a local anaesthetic).
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 (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients within 40 -70 years old.
- •Moderate to severe symptoms according to the QuickDASH scale during the last 3 months.
- •Patients with tendinitis, inflammatory or calcium, tendinosis or partial tears of the rotator cuff, diagnosed by ultrasound or MRI, evaluated by an expert radiologist and independent of research team.
- •Patients resistant to conservative treatment.
排除标准
- •Patients with complete tear of the rotator cuff diagnosed by ultrasound or MRI.
- •Patients who have previously received treatment with infiltrations in the last 6 months.
- •Patients with poorly controlled arterial Hypertension (AHT) and Diabetes mellitus.
- •Allergic to some of the components of Celestone Cronodose ®, either the drug or some of the excipients.
- •Patients on anticoagulants or antiplatelet therapy which cannot be reversed temporarily for the infiltrations.
- •Positive serology for sifilis, hepatitis B, hepatitis C or IHV I/II.
- •Uncapable to understand health questionnaires and / or complete them properly.
- •Women who might be pregnant and don't have a negative pregnancy test at the start of the study.
- •Breastfeeding women.
研究组 & 干预措施
Plasma rich in growth factors (PRGF)
This group will receive a total of three intraarticular injections of 6-8 ml. One injection every two weeks.
干预措施: Plasma rich in growth factors (PRGF) (Biological)
Celestone cronodose (bethametasone)
This group will receive a total of three intraarticular injections of 2ml. One injection every two weeks.
干预措施: Celestone cronodose (Bethametasone) (Drug)
结局指标
主要结局
15% of change in the score of the UCLA scale
时间窗: Baseline and 6 months
15% of change in the score of the QuickDash scale
时间窗: Baseline and 6 months
次要结局
- changes in the UCLA, Quickdash and Constant scales(12 months)
- Concentration of the platelet levels in the plasma administered and its relationship with the clinical effect measured with the UCLA and QuickDash scales.(24 months)