Benefit of a Subacromial Injection Combining Corticosteroid and Hyaluronic Acid Versus Corticosteroid Alone in Supraspinatus Tendinopathy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 3
- 主要终点
- Visual analog scale pain on activity ranging from 0 to 100 mm at month 3.
研究概览
简要总结
Multicentric, randomised study to compare the effectiveness on activity pain at 3 months of corticosteroid injection associated with hyaluronic acid with corticosteroids injection alone in patients with tendinopathy of the supraspinatus with clinical reevaluation at one, three and six months.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active patient aged between 18 and 65;
- •Patient suffering from pain compatible with supraspinatus tendinopathy for at least 2 months;
- •Patient with simple tendinopathy or partial tendon rupture;
- •Patient with tendinopathy confirmed by ultrasound or MRI;
- •Patient with an active pain visual analog scale ≥ 4 for more than 6 weeks;
- •Patient with an active pain visual analog scale ≥ 4 on the day of inclusion;
- •Patient failing medical treatment (rest, analgesics, NSAIDs, physiotherapy);
- •Patient able to follow the protocol and having given oral informed consent to take part in the research;
- •Patient affiliated to the social security system or entitled person;
排除标准
- •Patient suffering from a transfixing tendon rupture;
- •Patients suffering from post-traumatic tendon rupture;
- •Patients suffering from calcific tendinopathy (calcification > 5 mm);
- •Patients with associated glenohumeral osteoarthritis;
- •Patients with associated symptomatic acromioclavicular osteoarthritis;
- •Patients with shoulder pain for reasons other than tendinopathy (capsulitis, chronic inflammatory rheumatism, fibromyalgia, amyloidosis);
- •Patients who have had a subacromial infiltration in the previous 6 months;
- •Patients with a known allergy to one of the products including their excipients (methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol);
- •Patients with a known allergy to lidocaine;
- •Patients with a local or generalised infection, or suspected infection;
- •Patients with severe coagulation disorders or taking anticoagulants;
- •Patients with severe and/or uncontrolled hypertension > 160/100 mmHg;
- •Patients with unbalanced diabetes (last HbA1c > 8.5%);
- •Patients with a history of addiction to psychoactive substances;
- •Patient participating in another clinical research protocol with an impact on the research objectives;
- •Patient already randomised in the study;
- •Patient who is pregnant, parturient, breastfeeding or able to procreate without effective contraception* in the month prior to inclusion and up to 15 days after infiltration;
- •Patients under guardianship, curators or deprived of liberty;
- •Patient under a mandate for future protection activated ;
- •Patient under family guardianship ;
- •Patient under court protection ;
研究组 & 干预措施
Combination of corticosteroid and hyaluronic acid injection
An injection of 1 ml if corticosteroids and an injection of 2 ml of hyaluronic acid
干预措施: Corticosteroid injection (Drug)
Corticosteroid injection alone
An injection of 1 ml of corticosteroids and an injection of 2 ml of placebo (physiological serum).
干预措施: Placebo injection (Drug)
Corticosteroid injection alone
An injection of 1 ml of corticosteroids and an injection of 2 ml of placebo (physiological serum).
干预措施: Corticosteroid injection (Drug)
Combination of corticosteroid and hyaluronic acid injection
An injection of 1 ml if corticosteroids and an injection of 2 ml of hyaluronic acid
干预措施: Hyaluronic acid injection (Drug)
结局指标
主要结局
Visual analog scale pain on activity ranging from 0 to 100 mm at month 3.
时间窗: Month 3
Visual analog scale pain on activity ranging from 0 to 100 mm at month 3. Pain is defined by the worst pain felt during active examination: anterior elevation, abduction, internal and external rotation, etc.
次要结局
未报告次要终点