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

NCT07416916 | Recruiting Phase 4 DMC

• 1 other identifier: 2024-0434
• Study Type: interventional
• Target: 528
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Frozen Shoulder

Keywords

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

Outcome Measures

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.

  Baseline (Week 0) to Week 8

Secondary Outcomes (14)

• 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

Other Outcomes (4)

• Incidence of at Least One Serious Adverse Event (SAE)

  Up to 12 weeks

• Incidence of at Least One Adverse Event (AE)

  Up to 12 weeks

• Incidence of Injection-related Local Adverse Events

  Up to 12 weeks

Study Arms (2)

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).

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

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).

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

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.

Systemic steroid / Gluteal injection

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.

Systemic steroid / Gluteal injection

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.

Local steroid / Intra-articular injection

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.

Local steroid / Intra-articular injection; Systemic steroid / Gluteal injection

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.

Local steroid / Intra-articular injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (9)

Yangpu District Central Hospital of Shanghai

Shanghai, Shanghai Municipality, 200082, China

NOT YET RECRUITING

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

The First People's Hospital of Linping District, Hangzhou

Hangzhou, Zhejiang, 311199, China

NOT YET RECRUITING

Huzhou Central Hospital

Huzhou, Zhejiang, 313000, China

NOT YET RECRUITING

Pujiang People's Hospital

Jinhua, Zhejiang, 322200, China

NOT YET RECRUITING

First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315020, China

NOT YET RECRUITING

Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group

Ningbo, Zhejiang, 315799, China

NOT YET RECRUITING

Shengzhou People's Hospital

Shanhu, Zhejiang, 312400, China

NOT YET RECRUITING

MeSH Terms

Conditions

Bursitis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Bin Han, Medical Doctor

  The 2nd Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Han, Medical Doctor

CONTACT

+86-13735402700; icydoctor@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): January 1, 2031
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

CN (9)