Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to a Single Intrabursal Injection of Corticosteroids in Patients With Shoulder Calcific Tendinopathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Functional Improvement Measured According to Percentage Change in Constant Score
研究概览
简要总结
The purpose of this study is to compare the efficacy and effects on the hypothalamus-pituitary-adrenal axis of a single intrabursal injection of two different types of corticosteroids (methylprednisolone and triamcinolone) in patients with calcific shoulder tendinopathy.
详细描述
Rotator cuff calcific tendonitis is a common disease, mainly affecting women aged 30 to 50 years old. It is associated to severe pain and impotence. US-guided percutaneous treatment is considered the gold standard treatment with the aim to destroy and wash out shoulder's calcification, responsible for inflammation, pain and functional limitation. Corticosteroids are injected in the subacromial-subdeltoid bursa at the end of the procedure to facilitate the prompt pain relief and functional recovery. Although corticosteroids represent the most powerful drugs to reduce inflammation and pain, their use is associated to important side effects, mainly the suppression of the hypothalamus-pituitary-axis (HPA). At the same time, no standardized protocols exist regarding the best type and dose of corticosteroid to be injected in association to the above mentioned treatment, nor data evaluating the exact duration of HPA suppression following a single intrabursal injection of corticosteroids.
40 patients affected by rotator cuff calcific tendonitis will be enrolled in the study and randomly assigned to two groups: one group (20 patients) will be treated with a single intrabursal injection of 40 mg of methylprednisolone; the other group (20 patients) will be treated with a single intrabursal injection of 40 mg of triamcinolone.
All patients will be tested at time 0 (morning before treatment) and at 1, 7, 15, 30 and 45 days after the injection, using clinical, laboratory and US parameters in order to compare the efficacy and safety of the two drugs.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •painful rotator cuff calcific tendonitis demonstrated by ultrasounds
排除标准
- •pregnancy
- •use of corticosteroids in the previous 2 months
- •systemic chronic inflammatory or allergic diseases
- •allergy to methylprednisolone or triamcinolone
- •coagulopathies or current treatment with antiaggregants or anticoagulants
- •septic arthritis or infections
- •calcific enthesopathy
研究组 & 干预措施
methylprednisolone acetate group
Single intrabursal injection of methylprednisolone acetate
干预措施: methylprednisolone acetate (Drug)
Triamcinolone acetonide group
Single intrabursal injection of Triamcinolone acetonide
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Functional Improvement Measured According to Percentage Change in Constant Score
时间窗: 180 days after treatment
Patients will be evaluated clinically by Constant Score Constant score: range 0 (total shoulder impairment) to 100 (non impaired shoulder). The score is obtained from two subjective (pain and relation between pain and daily-life activities) - and two objective physician-assessed (strength and range of motion) measurements Reference: Constant CR and Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
次要结局
- Reduction of Pain Severity Expressed as Percentage Change in VAS Score(180 days after treatment)
- Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis(45 days after treatment)
研究者
milva.battaglia
Clinician, Principal Investigator, Department of Radiology
Istituto Ortopedico Rizzoli