Is the Presence of Subacromial Bursitis Associated With a Good Response to Ultrasound-guided Steroid Injection in Rotator Cuff Tendinopathy?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reduction in shoulder pain 3 months after the subacromial corticosteroid injection
研究概览
简要总结
Shoulder pain is a common reason for medical consultation affecting 6.7 % of the adults from 50 to 70 years old and until 21 % of the adults over 70. Among these painful shoulders, rotator cuff tendinopathy represents 44 to 65% of these consultations. To treat this condition, patients usually receive analgesics and physical therapy. When these treatments are not effective, a corticosteroid sub-acromial injection is proposed. However, according to the literature, there is only about 50% of good response to this subacromial injection in rotator cuff tendinopathy. It has been suggested that the injection could be more effective in the presence of an inflammation over the tendons called bursitis. However, no studies have clearly established this. The objective of the study is to determine if the presence of a bursitis could be a factor of good response to corticosteroid injection. The results could allow us to determine which patients have the best profile to respond to subacromial injection. The investigators hope that these data would improve the treatment of this frequent disease.
详细描述
Patients referred to receive a subacromial ultrasound-guided injection for shoulder pain related to a rotator cuff tendinopathy will be enrolled in the study. After validation of the inclusion criteria, the participants will receive oral information about the protocol. Then, they will be examined and will undergo X-rays and an ultrasound of their shoulder. Pain shoulder and shoulder disability will be assessed before the injection with a visual analogic pain scale and the Oxford Shoulder Score questionnaire, respectively.
The subacromial injection will be performed under ultrasound guidance to accurately inject the subacromial bursae. After skin disinfection with povidone, the injection will be performed with a 21G needle. The bursae will be injected with 2 ml of lidocaine 2% and 1 ml of betamethasone.
After the procedure, the participants will all receive a standardized physiotherapy.
For primary outcome, the therapeutic response will be assessed 3 months after the procedure. Patients will be considered as having a good response if their level of pain decreases by over 30%.
The number of participants having a good clinical response will be compared between the patients presenting a bursitis and those without bursitis. The comparison will be made using a Chi-2 test.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major patients with manifestations of rotator cuff tendinopathy referred to our rheumatology department to receive an ultrasound-guided subacromial injection.
排除标准
- •Patients refusing to participate
- •Allergic to local anesthetics
- •Shoulder involvement of an inflammatory rheumatic disease
- •History of shoulder surgery
- •Shoulder instability
- •Glenohumeral osteoarthritis
- •Frozen shoulder
- •Extended rotator cuff tear
- •Tendinous calcification > 0.5 cm
- •Pregnant women
- •Majors under guardianship
- •Patient inappropriate for entry into this study according to the judgment of the investigator
结局指标
主要结局
Reduction in shoulder pain 3 months after the subacromial corticosteroid injection
时间窗: 3 months
The primary outcome is the presence of a therapeutic response 3 months after the intervention. The level of pain will be assessed by a visual analogic pain scale of 0 (absence of pain) to 10 centimeters (maximal pain). Participants will be considered as good responders if their level of pain decreases more than 30 percent. Safety issue: No
次要结局
- Reduction in shoulder pain 6 weeks after the subacromial steroid injection.(6 weeks after the intervention)
- Presence of radiographic abnormalities associated with a good response.(data from Day 0, Week 6 and Month 3)
- Presence of other ultrasound lesions associated with a good response to steroid injection(data from Day 0, Week 6 and Month 3)
- Steroid injection safety(data from Day 0, Week 6 and Month 3)
- Reduction in OSS score (Oxford Shoulder Score) 6 weeks and 3 months after the injection(data from Day 0, Week 6 and Month 3)