The Efficacy of Single-shot Capsule-preserving Hydrodilatation With Corticosteroids in Treating Adhesive Capsulitis of the Shoulder: A Randomized Controlled Trial Versus Isolated Corticosteroid Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- American Shoulder and Elbow Surgeons (ASES) shoulder score
研究概览
简要总结
This clinical trial investigates whether concomitant capsule-preserving hydrodilatation (CSHD) is more effective than isolated glenohumeral corticosteroid injection (CS) in treating shoulder adhesive capsulitis. The main questions it aims to answer are
- Is CSHD inferior to CS in immediate pain relief as the solution is diluted?
- Is CSHD superior to CS in improving the range of motion as the contracted capsule is dilated?
Group CS will receive an ultrasound-guided glenohumeral corticosteroid injection only, with a solution of 5 mL.
Group CSHD will receive an ultrasound-guided glenohumeral corticosteroid with hydrodilatation, with a solution of 20 mL.
Clinical scores and range of motion will be compared between the groups up to six months post-injection.
详细描述
A single-centre, double-blinded, prospective randomised controlled trial involving patients diagnosed with adhesive capsulitis of the shoulder (AC).
Patients were randomly allocated to either corticosteroid injection with hydrodilatation (group CSHD) or corticosteroid injection only (group CS).
For the CS group, a solution of 1 mL triamcinolone (40mg) and 4 mL 1% lidocaine, 5 mL in total, was injected intraarticularly through the posterior approach using ultrasound guidance.
The CSHD group received an injection of 20 mL with 15 mL of normal saline added to the abovementioned 5 mL solution. The dilatation of the joint capsule was confirmed by the increase in distance between the capsule and the humeral head.
Patients underwent the following assessments just before the injection, and at post-injection three weeks, seven weeks, three months, 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)
盲法说明
A final number of 50 patients were enrolled in the trial and randomly assigned to either the isolated corticosteroid injection group (Group CS) or the concomitant hydrodilatation group (Group CSHD). Double-blinded randomization was performed by an independent nurse using a computer-generated random sequence. A musculoskeletal radiologist, blinded to group allocation, performed the diagnostic ultrasound and MRI interpretations. A blinded orthopaedic nurse carried out the physical examination and clinical scoring.
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two or more of the following criteria within the shoulder's range of motion:
- •Abduction and forward elevation below 100˚
- •External rotation at the side below 30˚
- •Internal rotation at 90˚ of abduction below 30˚
排除标准
- •History of shoulder surgery, trauma, nerve injury
- •Concomitant rotator cuff/biceps lesions in ultrasound or MRI
- •Glenohumeral arthritis in simple X-ray
- •Calcific tendinosis in simple X-ray
- •Underlying conditions: cancer, mental illness, hormonal imbalance
- •Diabetes with HbA1c levels exceeding 7.0%
研究组 & 干预措施
Isolated corticosteroid injection
Ultrasound-guided posterior approach of glenohumeral space injection for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine.
干预措施: Ultrasound-guided glenohumeral space isolated corticosteroid injection (Procedure)
Isolated corticosteroid injection
Ultrasound-guided posterior approach of glenohumeral space injection for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine.
干预措施: 4mL of Lidocaine 1% Solution Injectable Solution (Drug)
Concomitant hydrodilatation with corticosteroid injection
Ultrasound-guided posterior approach of glenohumeral space hydrodilatation for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, and 15 mL normal saline
干预措施: Ultrasound-guided glenohumeral space concomitant hydrodilatation with corticosteroid injection (Procedure)
Concomitant hydrodilatation with corticosteroid injection
Ultrasound-guided posterior approach of glenohumeral space hydrodilatation for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, and 15 mL normal saline
干预措施: 4mL of Lidocaine 1% Solution Injectable Solution (Drug)
Concomitant hydrodilatation with corticosteroid injection
Ultrasound-guided posterior approach of glenohumeral space hydrodilatation for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, and 15 mL normal saline
干预措施: 15mL of Normal Saline (Drug)
Isolated corticosteroid injection
Ultrasound-guided posterior approach of glenohumeral space injection for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine.
干预措施: 1mL of Triamcinolone (40mg/1mL) Injectable Solution (Drug)
Concomitant hydrodilatation with corticosteroid injection
Ultrasound-guided posterior approach of glenohumeral space hydrodilatation for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, and 15 mL normal saline
干预措施: 1mL of Triamcinolone (40mg/1mL) Injectable Solution (Drug)
结局指标
主要结局
American Shoulder and Elbow Surgeons (ASES) shoulder score
时间窗: Change from the baseline to 7 weeks
Patient-reported shoulder satisfaction score, 0-100, higher scores mean a better outcome.
次要结局
- Constant-Murley score(Change from the baseline to 6 months)
- Visual analog scale (VAS) for pain(Change from the baseline to 6 months)
- Range of motion (ROM)(Change from the baseline to 6 months)
研究者
Jung-Taek Hwang
Professor
Chuncheon Sacred Heart Hospital