Gluteal versus ultrasound-guided corticosteroid injections for frozen shoulder

Ultrasound-Guided Intra-Articular Versus Systemic Corticosteroid Injection for Frozen Shoulder: A Multicenter, Blinded, Randomized Controlled Trial

This test will see if a buttock (gluteal) injection of compound betamethasone works as well as an ultrasound-guided steroid injection into the shoulder joint for adults 18–65 with frozen shoulder.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 528 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 9 sites (Shanghai, Shanghai Municipality and 8 other locations)
• Trial ID: NCT07416916 on ClinicalTrials.gov

What this trial studies

Adults with unilateral primary frozen shoulder receive one injection at baseline—either a dorsogluteal intramuscular betamethasone injection, an ultrasound-guided intra-articular betamethasone injection, or a matching saline placebo by the same route—and all participants follow a standardized home-based shoulder rehabilitation program. Shoulder pain, passive range of motion, and functional scores are collected over 12 weeks to compare pain relief, improvement in function, and side effects between the injection methods. Intra-articular injections are performed under ultrasound guidance while intramuscular injections use a standard dorsogluteal approach, and assessments use standardized pain scales and ROM measurements. The primary aim is to see if the simpler gluteal injection provides similar clinical benefit to the ultrasound-guided intra-articular injection.

Who should consider this trial

Good fit: Adults 18–65 with a unilateral primary (idiopathic) frozen shoulder of ≤9 months' duration, worst shoulder pain ≥4/10, and at least a 30° loss of passive motion in two shoulder directions with no other structural shoulder disease on X‑ray.

Not a fit: People with secondary frozen shoulder caused by other medical conditions, those outside the 18–65 age range, or those with other excluded shoulder structural problems are unlikely to be eligible or to benefit from this comparison.

Why it matters

Potential benefit: If successful, patients could have an easier, lower-cost injection option that reduces pain and improves shoulder motion without requiring ultrasound guidance.

How similar studies have performed: Previous studies show intra-articular corticosteroid injections can relieve pain and improve function in frozen shoulder, while using intramuscular gluteal steroid injections as an alternative has been less well studied.

Eligibility criteria

Inclusion Criteria (all must be met):

1. Symptom duration ≤9 months; clinically diagnosed unilateral primary (idiopathic) frozen shoulder (including diabetes-associated frozen shoulder).
2. Age 18 to 65 years.
3. Worst shoulder pain in the past 24 hours (NRS-WP, 0-10) ≥4.
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.
5. 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.

Exclusion Criteria (any of the following):

1. 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).
2. Confirmed or highly suspected full-thickness or massive rotator cuff tear causing functional pseudoparalysis (e.g., positive Jobe test with marked strength loss).
3. Local infection of the affected shoulder or any contraindication to shoulder injection (e.g., uncorrected bleeding risk/coagulopathy).
4. Contraindication to corticosteroid therapy (e.g., poorly controlled diabetes, systemic infection).
5. Prior manipulation under anesthesia, arthroscopic capsular release, or open surgical release for frozen shoulder on the affected shoulder.
6. Any corticosteroid treatment via any route within the past 3 months (including shoulder injection).
7. Requires long-term or intermittent corticosteroid use for other conditions (e.g., autoimmune disease such as rheumatoid arthritis, acute asthma exacerbations).
8. Bilateral frozen shoulder, or contralateral history of frozen shoulder not yet fully recovered.
9. Conditions significantly affecting upper-limb function assessment or ability to perform rehabilitation (e.g., marked limb disability).
10. Pregnant or breastfeeding.
11. Lacks the cognitive ability to comply with study procedures.
12. Does not reside in the region served by the participating hospital(s) (anticipated inability to complete follow-up).
13. Compensation claims (e.g., work-related injury, traffic accident) or ongoing legal disputes/litigation.

Where this trial is running

Shanghai, Shanghai Municipality and 8 other locations

• Yangpu District Central Hospital of Shanghai — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• The Third Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
• The First People's Hospital of Linping District, Hangzhou — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Huzhou Central Hospital — Huzhou, Zhejiang, China (Not_yet_recruiting)
• Pujiang People's Hospital — Jinhua, Zhejiang, China (Not_yet_recruiting)
• First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Not_yet_recruiting)
• Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group — Ningbo, Zhejiang, China (Not_yet_recruiting)
• Shengzhou People's Hospital — Shanhu, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Bin Han, Medical Doctor — The 2nd Affiliated Hospital of Zhejiang University
• Study coordinator: Bin Han, Medical Doctor

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