Comparison Between Ultrasound Guided Subacromial and Systemic Injection of Steroid for Frozen Shoulder: a Double Blind Multicenter Pilot Study for Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 9
- 主要终点
- Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
The goal of this multicenter pilot study is to validate the effectiveness of extending the injection interval between betamethasone doses from one to two weeks for treating frozen shoulder (adhesive capsulitis) in adults aged 18 to 75. This study also aims to screen potential study centers and gather data to refine the sample size calculation for a larger, future trial. The main questions it aims to answer are:
- Does extending the interval between injections maintain effectiveness in improving shoulder function and reducing pain for frozen shoulder?
- Which centers in this pilot study are qualified for a larger, future trial?
- What is the appropriate sample size for conducting a multicenter RCT study with the same research design at the selected centers?
Participants will:
- Receive 3 injections over 4 weeks and will be followed up for another 8 weeks
- Complete shoulder function assessments
- Perform home rehabilitation exercises
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of ≤9 months, clinically diagnosed with primary frozen shoulder (including frozen shoulder associated with diabetes).
- •Aged between 18 and 75 years old
- •Pain NRS score ≥4
- •Measured passive range of motion of the affected shoulder in at least two of the three directions (forward flexion, external rotation with arm at the side, and internal rotation with arm at the side) is reduced by 25% or more compared to the contralateral normal shoulder.
- •Exclusion of osteoarthritis, dislocation, and other shoulder abnormalities through X-ray and MRI of the affected shoulder.
排除标准
- •Secondary frozen shoulder caused by thyroid disease, cardiovascular disease, cancer, stroke, radiotherapy, neurosurgery, or breast surgery (excluding diabetes); secondary frozen shoulder caused by major shoulder trauma requiring medical care (e.g., fractures, dislocations, rotator cuff tears).
- •Full-thickness rotator cuff tear in the affected shoulder confirmed by MRI (excluding rotator cuff tendinopathy and partial-thickness rotator cuff tear in patients with frozen shoulder without a history of major shoulder trauma).
- •Patients unable to undergo MRI due to financial reasons, claustrophobia, pacemaker, or other metallic implants in the body.
- •Local infection in the affected shoulder or other contraindications to shoulder injections.
- •Patients with contraindications to steroid therapy (e.g., poorly controlled blood sugar in diabetes).
- •Patients with frozen shoulder who have already undergone shoulder injections, manipulation under anesthesia, arthroscopic capsular release, or open surgery for capsular release.
- •Received any form of steroid treatment within the past 3 months.
- •History of glucocorticoid use for more than 3 months.
- •Bilateral frozen shoulder or a history of frozen shoulder in the contralateral shoulder.
- •Pregnant or breastfeeding women.
- •Patients lacking the cognitive ability to comply with the study protocol.
- •Patients not residing in the area where the study is being conducted.
- •Patients with compensation claims or legal disputes related to workplace injury or car accidents.
研究组 & 干预措施
gluteal injection
gluteal injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4, ultrasound-guided subacromial injection of 5 ml of normal saline at week 0,2,4.
The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session.
干预措施: Compound betamethasone Injection(Gluteal muscle injection) (Drug)
subacromial injection
gluteal injection of 5 ml normal saline at week 0,2,4, ultrasound-guided subacromial injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4.
The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session.
干预措施: Compound betamethasone Injection(Subacromial Ultrasound Guided injection) (Drug)
gluteal injection
gluteal injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4, ultrasound-guided subacromial injection of 5 ml of normal saline at week 0,2,4.
The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session.
干预措施: Normal Saline as Placebo (ultrasound-guided subacromial injection) (Other)
gluteal injection
gluteal injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4, ultrasound-guided subacromial injection of 5 ml of normal saline at week 0,2,4.
The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session.
干预措施: home exercise (Behavioral)
subacromial injection
gluteal injection of 5 ml normal saline at week 0,2,4, ultrasound-guided subacromial injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4.
The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session.
干预措施: Normal Saline as Placebo (gluteal muscle inection) (Other)
subacromial injection
gluteal injection of 5 ml normal saline at week 0,2,4, ultrasound-guided subacromial injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4.
The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session.
干预措施: home exercise (Behavioral)
结局指标
主要结局
Shoulder Pain and Disability Index (SPADI)
时间窗: Baseline and 12 weeks
The SPADI score ranges from 0 to 100. A score of 0 indicates no pain or disability, while a score of 100 reflects the worst possible pain and maximum functional disability in the shoulder. Data entry will be performed by blinded research staff. They will present the paper CRF sample form to the participants and ask questions one by one, directly entering the responses of participants into the corresponding electronic CRF form in the EDC system using handheld electronic devices (such as smartphones, tablets, or laptops).
次要结局
- progression rate of rotator cuff tears(From enrollment to the end of follow-up at 12 weeks)
- short version of Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH）(Baseline and 12 weeks)
- Numerical Rating Scale (NRS)(Baseline and 12 weeks)
- five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)(Baseline and 12 weeks)
- passive range of motion of shoulder(Baseline and 12 weeks)
- Direct Medical Cost(Week8 and week12)
- work absenteeism(Week 8 and Week 12)
- Unplanned concomitant use of analgesics(Week 12)
- Glycated Hemoglobin (HbA1c)(week 0 and week 12)
- glycated albumin(week 0 and week 4)
- Direct Medical Cost(Baseline)
- work absenteeism(Week 0 and Week 2)
- Direct Medical Cost(Baseline and week2)
- Direct Medical Cost(Week2 and week4)
- Direct Medical Cost(Week4 and week8)
- work absenteeism(Week 0)
- work absenteeism(Week 2 and Week 4)
- work absenteeism(Week 4 and Week 8)
- Unplanned concomitant use of analgesics(Week 2)
- Unplanned concomitant use of analgesics(Week 4)
- Unplanned concomitant use of analgesics(Week 8)