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
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) ≥4.
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.
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).
Parallel
Compound betamethasone injection (dorsogluteal intramuscular)
DrugA single dorsogluteal intramuscular injection at Week 0 (baseline): compound betamethasone 1 mL mixed with 0.9% sodium chloride 4 mL (total volume 5 mL), as part of a double-dummy design.
Compound betamethasone injection (ultrasound-guided intra-articular glenohumeral)
DrugA single ultrasound-guided intra-articular glenohumeral injection at Week 0 (baseline): compound betamethasone 1 mL mixed with 0.9% sodium chloride 4 mL (total volume 5 mL), as part of a double-dummy design.
0.9% sodium chloride injection (ultrasound-guided intra-articular glenohumeral placebo)
DrugA single ultrasound-guided intra-articular glenohumeral placebo injection at Week 0 (baseline): 0.9% sodium chloride 5 mL, to mimic the local (intra-articular) injection in the double-dummy design.
0.9% sodium chloride injection (dorsogluteal intramuscular placebo)
DrugA single dorsogluteal intramuscular placebo injection at Week 0 (baseline): 0.9% sodium chloride 5 mL, to mimic the systemic (intramuscular) injection in the double-dummy design.
Standardized home-based shoulder rehabilitation exercise program
Other interventionAll participants perform a standardized home-based rehabilitation exercise program for 12 weeks after outpatient instruction, approximately 40 minutes per day (twice daily, 20 minutes per session), following the study-provided instructional video.
Change in Shoulder Pain and Disability Index (SPADI) Total Score from Baseline 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.
Change in QuickDASH Score from Baseline to Week 8
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score (official Simplified Chinese version; range 0-100, where 0 = no disability and 100 = most severe disability; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 8 (Week 8 minus Week 0); negative change indicates improvement.
Change in EQ-5D-5L Index Score from Baseline to Week 8
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) health utility index (Simplified Chinese version; index derived using the Chinese value set; range -0.391 to 1.000, where 1.000 = full health and higher scores indicate better health-related quality of life). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 8 (Week 8 minus Week 0); positive change indicates improvement.
Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) from Baseline to Week 8
Worst shoulder pain in the past 24 hours measured by a Numeric Rating Scale (NRS) item from the Brief Pain Inventory-Chinese version (BPI-C) (range 0-10, where 0 = no pain and 10 = worst imaginable pain; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 8 (Week 8 minus Week 0); negative change indicates improvement.
Change in Passive Shoulder Range of Motion (ROM) from Baseline to Week 8
Passive shoulder range of motion (ROM) of the affected shoulder assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Passive flexion measured by goniometer (0-180 degrees; higher degrees indicate better ROM), passive abduction by goniometer (0-180 degrees; higher degrees indicate better ROM), and passive external rotation at side by goniometer (-20 to 90 degrees; higher degrees indicate better ROM). Passive internal rotation is recorded as a 1-18 score based on the highest spinal level reached by the thumb tip behind the back (1-12 = T1-T12, 13-17 = L1-L5, 18 = sacral region or below; lower score indicates better ROM). Endpoint is the change from baseline to Week 8 (Week 8 minus Week 0).
Incidence of at Least One Serious Adverse Event (SAE)
Counts and proportion of participants experiencing ≥1 SAE during the 12-week follow-up
Incidence of at Least One Adverse Event (AE)
Counts and proportion of participants experiencing ≥1 AE during the 12-week follow-up.
Incidence of Injection-related Local Adverse Events
Incidence of injection-related local adverse events during follow-up, including pre-defined, systematically assessed local AEs (AESI; solicited at scheduled visits) (e.g., marked post-injection shoulder pain flare, local infection, skin/subcutaneous changes) and investigator-attributed injection-related local AEs identified non-systematically (unsolicited reports/clinical assessment/medical record review), including injection-related events not pre-specified as AESI.
Incidence of Injection-related Systemic Adverse Events
Incidence of injection-related systemic adverse events during follow-up, including pre-defined, systematically assessed systemic AEs (AESI; solicited at scheduled visits) (e.g., facial flushing, mood/sleep changes, gastrointestinal discomfort, transient hyperglycemia/hypertension, suspected adrenal suppression) and investigator-attributed injection-related systemic AEs identified non-systematically (unsolicited reports/clinical assessment/medical record review), including injection-related events not pre-specified as AESI.
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