Ultrasound-Guided Intra-Articular Versus Systemic Corticosteroid Injection for Frozen Shoulder: A Multicenter, Blinded, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 528
- 试验地点
- 9
- 主要终点
- Change in Shoulder Pain and Disability Index (SPADI) Total Score from Baseline to Week 8
研究概览
简要总结
The goal of this clinical trial is to determine if a gluteal muscle injection of compound betamethasone is as effective as an ultrasound-guided intra-articular injection in treating frozen shoulder (adhesive capsulitis) in adults aged 18 to 65. The main questions it aims to answer are:
- Is gluteal injection as effective as ultrasound-guided intra-articular injection for improving shoulder function and reducing pain?
- What are the side effects of each treatment method? Researchers will compare these two injection methods.
Participants will:
- Receive one injection at baseline and will be followed up for 12 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)
盲法说明
Participants and outcome assessors are blinded to treatment allocation (double-dummy; participant-blinded and assessor-blinded). Designated unblinded injection administrators access the randomization result and prepare/perform the assigned injections; they are not involved in any follow-up assessments, outcome data collection, or outcome data entry, and have restricted, role-based access in the EDC/IWRS. Syringes and the injection field are shielded and standardized scripts are used to minimize unblinding.
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
- •(all must be met):
- •Symptom duration ≤9 months; clinically diagnosed unilateral primary (idiopathic) frozen shoulder (including diabetes-associated frozen shoulder).
- •Age 18 to 65 years.
- •Worst shoulder pain in the past 24 hours (NRS-WP, 0-10) ≥
- •Passive range of motion (ROM) limitation of the affected shoulder: compared with the contralateral normal shoulder, a decrease of ≥30° in at least two of the following three directions: forward flexion, abduction, and external rotation with the arm at the side.
- •Radiographic exclusion of other shoulder pathology: Affected-shoulder anteroposterior (AP) radiograph excludes glenohumeral osteoarthritis, calcific tendinopathy, and other structural abnormalities; and axillary view and/or scapular Y (outlet) or transthoracic view excludes glenohumeral dislocation.
排除标准
- •(any of the following):
- •Secondary frozen shoulder due to thyroid disease, cardiovascular disease, stroke, radiotherapy, prior neurosurgical or breast surgery, etc. (diabetes excluded from this item); or frozen shoulder secondary to major shoulder trauma requiring medical care (e.g., fracture, dislocation, rotator cuff tear).
- •Confirmed or highly suspected full-thickness or massive rotator cuff tear causing functional pseudoparalysis (e.g., positive Jobe test with marked strength loss).
- •Local infection of the affected shoulder or any contraindication to shoulder injection (e.g., uncorrected bleeding risk/coagulopathy).
- •Contraindication to corticosteroid therapy (e.g., poorly controlled diabetes, systemic infection).
- •Prior manipulation under anesthesia, arthroscopic capsular release, or open surgical release for frozen shoulder on the affected shoulder.
- •Any corticosteroid treatment via any route within the past 3 months (including shoulder injection).
- •Requires long-term or intermittent corticosteroid use for other conditions (e.g., autoimmune disease such as rheumatoid arthritis, acute asthma exacerbations).
- •Bilateral frozen shoulder, or contralateral history of frozen shoulder not yet fully recovered.
- •Conditions significantly affecting upper-limb function assessment or ability to perform rehabilitation (e.g., marked limb disability).
- •Pregnant or breastfeeding.
- •Lacks the cognitive ability to comply with study procedures.
- •Does not reside in the region served by the participating hospital(s) (anticipated inability to complete follow-up).
- •Compensation claims (e.g., work-related injury, traffic accident) or ongoing legal disputes/litigation.
研究组 & 干预措施
Systemic steroid / Gluteal injection
At Week 0 (baseline), participants receive a single dorsogluteal intramuscular injection of compound betamethasone injection 1 mL diluted with 0.9% sodium chloride 4 mL (total volume 5 mL), plus a single ultrasound-guided intra-articular glenohumeral injection of 0.9% sodium chloride 5 mL (placebo) as part of a double-dummy design. All participants follow a standardized home-based shoulder rehabilitation program for 12 weeks (approximately 40 minutes/day; twice daily, 20 minutes/session).
干预措施: 0.9% sodium chloride injection (ultrasound-guided intra-articular glenohumeral placebo) (Drug)
Systemic steroid / Gluteal injection
At Week 0 (baseline), participants receive a single dorsogluteal intramuscular injection of compound betamethasone injection 1 mL diluted with 0.9% sodium chloride 4 mL (total volume 5 mL), plus a single ultrasound-guided intra-articular glenohumeral injection of 0.9% sodium chloride 5 mL (placebo) as part of a double-dummy design. All participants follow a standardized home-based shoulder rehabilitation program for 12 weeks (approximately 40 minutes/day; twice daily, 20 minutes/session).
干预措施: Compound betamethasone injection (dorsogluteal intramuscular) (Drug)
Local steroid / Intra-articular injection
At Week 0 (baseline), participants receive a single ultrasound-guided intra-articular glenohumeral injection of compound betamethasone injection 1 mL diluted with 0.9% sodium chloride 4 mL (total volume 5 mL), plus a single dorsogluteal intramuscular injection of 0.9% sodium chloride 5 mL (placebo) as part of a double-dummy design. All participants follow a standardized home-based shoulder rehabilitation program for 12 weeks (approximately 40 minutes/day; twice daily, 20 minutes/session).
干预措施: Compound betamethasone injection (ultrasound-guided intra-articular glenohumeral) (Drug)
Systemic steroid / Gluteal injection
At Week 0 (baseline), participants receive a single dorsogluteal intramuscular injection of compound betamethasone injection 1 mL diluted with 0.9% sodium chloride 4 mL (total volume 5 mL), plus a single ultrasound-guided intra-articular glenohumeral injection of 0.9% sodium chloride 5 mL (placebo) as part of a double-dummy design. All participants follow a standardized home-based shoulder rehabilitation program for 12 weeks (approximately 40 minutes/day; twice daily, 20 minutes/session).
干预措施: Standardized home-based shoulder rehabilitation exercise program (Other)
Local steroid / Intra-articular injection
At Week 0 (baseline), participants receive a single ultrasound-guided intra-articular glenohumeral injection of compound betamethasone injection 1 mL diluted with 0.9% sodium chloride 4 mL (total volume 5 mL), plus a single dorsogluteal intramuscular injection of 0.9% sodium chloride 5 mL (placebo) as part of a double-dummy design. All participants follow a standardized home-based shoulder rehabilitation program for 12 weeks (approximately 40 minutes/day; twice daily, 20 minutes/session).
干预措施: 0.9% sodium chloride injection (dorsogluteal intramuscular placebo) (Drug)
Local steroid / Intra-articular injection
At Week 0 (baseline), participants receive a single ultrasound-guided intra-articular glenohumeral injection of compound betamethasone injection 1 mL diluted with 0.9% sodium chloride 4 mL (total volume 5 mL), plus a single dorsogluteal intramuscular injection of 0.9% sodium chloride 5 mL (placebo) as part of a double-dummy design. All participants follow a standardized home-based shoulder rehabilitation program for 12 weeks (approximately 40 minutes/day; twice daily, 20 minutes/session).
干预措施: Standardized home-based shoulder rehabilitation exercise program (Other)
结局指标
主要结局
Change in Shoulder Pain and Disability Index (SPADI) Total Score from Baseline to Week 8
时间窗: Baseline (Week 0) to Week 8
Shoulder Pain and Disability Index (SPADI) total score (validated Simplified Chinese version; range 0-100, where 0 = no pain/disability and 100 = worst pain/disability; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Primary endpoint is the change from baseline to Week 8 (Week 8 minus Week 0); negative change indicates improvement.
次要结局
- Change in QuickDASH Score from Baseline to Week 8(Baseline (Week 0) to Week 8)
- Change in EQ-5D-5L Index Score from Baseline to Week 8(Baseline (Week 0) to Week 8)
- Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) from Baseline to Week 8(Baseline (Week 0) to Week 8)
- Change in Passive Shoulder Range of Motion (ROM) from Baseline to Week 8(Week 0 (baseline) to Week 8)
- Change in SPADI Total Score from Baseline to Week 12(Baseline (Week 0) to Week 12)
- Change in QuickDASH Score from Baseline to Week 12(Baseline (Week 0) to Week 12)
- Change in EQ-5D-5L Index Score from Baseline to Week 12(Baseline (Week 0) to Week 12)
- Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) from Baseline to Week 12(Baseline (Week 0) to Week 12)
- Change in Passive Shoulder ROM from Baseline to Week 12(Baseline (Week 0) to Week 12)
- Change in SPADI Total Score over 12 Weeks (Longitudinal)(SPADI total score assessed at Weeks 0/2/4/8/12; longitudinal change over 12 weeks will be evaluated.)
- Change in QuickDASH Score over 12 Weeks (Longitudinal)(Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12)
- Change in EQ-5D-5L Index Score over 12 Weeks (Longitudinal)(Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12)
- Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) over 12 Weeks (Longitudinal)(Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12)
- Change in Passive Shoulder Range of Motion (ROM) over 12 Weeks (Longitudinal)(Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12)