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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systemic steroid / Gluteal injection | Experimental | 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). |
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| Local steroid / Intra-articular injection | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound betamethasone injection (dorsogluteal intramuscular) | Drug | A 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Week 0) to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of at Least One Serious Adverse Event (SAE) | Counts and proportion of participants experiencing ≥1 SAE during the 12-week follow-up | Up to 12 weeks |
| Incidence of at Least One Adverse Event (AE) |
Inclusion Criteria (all must be met):
Exclusion Criteria (any of the following):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Han, Medical Doctor | Contact | +86-13735402700 | icydoctor@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Bin Han, Medical Doctor | The 2nd Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yangpu District Central Hospital of Shanghai | Not yet recruiting | Shanghai | Shanghai Municipality | 200082 | China |
Analytic dataset: beginning 6 months after online publication of the primary results; Full analyzable dataset: beginning 12 months after online publication; Both available until 5 years after online publication of the primary results.
Proposals from bona fide researchers will be reviewed by the Data Access Committee (DAC); approved requestors must execute a Data Use Agreement (DUA) and access data via a secure environment; no redistribution or re-identification.
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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.
| Compound betamethasone injection (ultrasound-guided intra-articular glenohumeral) | Drug | A 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) | Drug | A 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) | Drug | A 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. |
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| Standardized home-based shoulder rehabilitation exercise program | Other | All 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. |
|
| Baseline (Week 0) to Week 8 |
| 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. | Baseline (Week 0) to Week 8 |
| 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. | Baseline (Week 0) to Week 8 |
| 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). | Week 0 (baseline) to Week 8 |
| Change in SPADI Total Score from Baseline to Week 12 | Shoulder Pain and Disability Index (SPADI) total score (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. Endpoint is the change from baseline to Week 12 (Week 12 minus Week 0); negative change indicates improvement. | Baseline (Week 0) to Week 12 |
| Change in QuickDASH Score from Baseline to Week 12 | Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score (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 12 (Week 12 minus Week 0); negative change indicates improvement. | Baseline (Week 0) to Week 12 |
| Change in EQ-5D-5L Index Score from Baseline to Week 12 | EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) health utility index (index derived using the Chinese value set; range -0.391 to 1.000; 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 12 (Week 12 minus Week 0); positive change indicates improvement. | Baseline (Week 0) to Week 12 |
| Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) from Baseline to Week 12 | Worst shoulder pain in the past 24 hours measured by Numeric Rating Scale (NRS) (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 12 (Week 12 minus Week 0); negative change indicates improvement. | Baseline (Week 0) to Week 12 |
| Change in Passive Shoulder ROM from Baseline to Week 12 | 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 12 (Week 12 minus Week 0). | Baseline (Week 0) to Week 12 |
| Change in SPADI Total Score over 12 Weeks (Longitudinal) | Shoulder Pain and Disability Index (SPADI) total score (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. Longitudinal change in SPADI total score over 12 weeks will be evaluated; decreasing scores over time indicate improvement. | 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) | Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score (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. Longitudinal change in QuickDASH score over 12 weeks will be evaluated; decreasing scores over time indicate improvement. | Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12 |
| Change in EQ-5D-5L Index Score over 12 Weeks (Longitudinal) | EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) health utility index (index derived using the Chinese value set; range -0.391 to 1.000; higher scores indicate better health-related quality of life). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Longitudinal change in EQ-5D-5L index over 12 weeks will be evaluated; increasing scores over time indicate improvement. | 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) | Worst shoulder pain in the past 24 hours measured by Numeric Rating Scale (NRS) (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. Longitudinal change in NRS over 12 weeks will be evaluated; decreasing scores over time indicate improvement. | Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12 |
| Change in Passive Shoulder Range of Motion (ROM) over 12 Weeks (Longitudinal) | Passive shoulder range of motion (ROM) of the affected shoulder assessed longitudinally 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). Longitudinal change over 12 weeks will be evaluated. | Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12 |
Counts and proportion of participants experiencing ≥1 AE during the 12-week follow-up.
| Up to 12 weeks |
| 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. | Up to 12 weeks |
| 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. | Up to 12 weeks |
| The Third Affiliated Hospital of Zhejiang Chinese Medical University | Not yet recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| The First People's Hospital of Linping District, Hangzhou | Not yet recruiting | Hangzhou | Zhejiang | 311199 | China |
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| Huzhou Central Hospital | Recruiting | Huzhou | Zhejiang | 313000 | China |
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| Pujiang People's Hospital | Not yet recruiting | Jinhua | Zhejiang | 322200 | China |
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| First Affiliated Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | 315020 | China |
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| Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group | Not yet recruiting | Ningbo | Zhejiang | 315799 | China |
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| Shengzhou People's Hospital | Not yet recruiting | Shanhu | Zhejiang | 312400 | China |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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