Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder

Browse trials for

• Bursitis 383

Keywords

• frozen shoulder
• intramuscular injection
• compound betamethasone
• ultrasound guidance
• intra-articular injection

Bursitis

383 studies on the registry are indexed under Bursitis; 111 are open to participants now.

This study's planned enrollment of 528 is above the median of 44 across 346 interventional studies indexed under Bursitis.

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 99 studies on the registry; 67 are open to participants now.

Study arms

• Experimental
  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).

  Drug: Compound betamethasone injection (dorsogluteal intramuscular) · Drug: 0.9% sodium chloride injection (ultrasound-guided intra-articular glenohumeral placebo) · Other: Standardized home-based shoulder rehabilitation exercise program

• Active comparator
  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).

  Drug: Compound betamethasone injection (ultrasound-guided intra-articular glenohumeral) · Drug: 0.9% sodium chloride injection (dorsogluteal intramuscular placebo) · Other: Standardized home-based shoulder rehabilitation exercise program

Interventions

• DrugCompound betamethasone injection (dorsogluteal intramuscular)

  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.

• DrugCompound betamethasone injection (ultrasound-guided intra-articular glenohumeral)

  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.

• Drug0.9% sodium chloride injection (ultrasound-guided intra-articular glenohumeral placebo)

  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.

• Drug0.9% sodium chloride injection (dorsogluteal intramuscular placebo)

  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.

• OtherStandardized home-based shoulder rehabilitation exercise program

  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.

Primary outcomes

1. 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.

   Time frame: Baseline (Week 0) to Week 8

Secondary outcomes

1. 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.

   Time frame: Baseline (Week 0) to Week 8

2. 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.

   Time frame: Baseline (Week 0) to Week 8

3. 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.

   Time frame: Baseline (Week 0) to Week 8

4. 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).

   Time frame: Week 0 (baseline) to Week 8

5. 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.

   Time frame: Baseline (Week 0) to Week 12

6. 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.

   Time frame: Baseline (Week 0) to Week 12

7. 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.

   Time frame: Baseline (Week 0) to Week 12

8. 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.

   Time frame: Baseline (Week 0) to Week 12

9. 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).

   Time frame: Baseline (Week 0) to Week 12

10. 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.

    Time frame: SPADI total score assessed at Weeks 0/2/4/8/12; longitudinal change over 12 weeks will be evaluated.

11. 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.

    Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12

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.

    Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12

13. 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.

    Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12

14. 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.

    Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12

Other outcomes

1. Incidence of at Least One Serious Adverse Event (SAE)

   Counts and proportion of participants experiencing ≥1 SAE during the 12-week follow-up

   Time frame: Up to 12 weeks

2. Incidence of at Least One Adverse Event (AE)

   Counts and proportion of participants experiencing ≥1 AE during the 12-week follow-up.

   Time frame: Up to 12 weeks

3. 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.

   Time frame: Up to 12 weeks

4. 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.

   Time frame: Up to 12 weeks

Individual participant data

Plan to share: Yes — Analytic dataset sufficient to reproduce the primary publication results (deidentified IPD with data dictionary and derivation specifications) and scripts for main tables/figures; Full analyzable dataset sufficient to support protocol-specified primary/secondary outcomes and prespecified subgroup/sensitivity analyses (deidentified IPD with data dictionary and derivation specifications).

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: 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.

Access criteria: 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.