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

Official title

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

Overview

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

Interventions

• Drug Compound 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.
• Drug Compound 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.
• Drug 0.9% 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.
• Drug 0.9% 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.
• Other Standardized 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 outcome measures

• Change in Shoulder Pain and Disability Index (SPADI) Total Score from Baseline to Week 8 [Time frame: Baseline (Week 0) to Week 8]

Secondary outcome measures (12)

• Change in QuickDASH Score from Baseline to Week 8 [Time frame: Baseline (Week 0) to Week 8]
• Change in EQ-5D-5L Index Score from Baseline to Week 8 [Time frame: Baseline (Week 0) to Week 8]
• Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) from Baseline to Week 8 [Time frame: Baseline (Week 0) to Week 8]
• Change in Passive Shoulder Range of Motion (ROM) from Baseline to Week 8 [Time frame: Week 0 (baseline) to Week 8]
• Change in SPADI Total Score from Baseline to Week 12 [Time frame: Baseline (Week 0) to Week 12]
• Change in QuickDASH Score from Baseline to Week 12 [Time frame: Baseline (Week 0) to Week 12]
• Change in EQ-5D-5L Index Score from Baseline to Week 12 [Time frame: Baseline (Week 0) to Week 12]
• Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) from Baseline to Week 12 [Time frame: Baseline (Week 0) to Week 12]
• Change in Passive Shoulder ROM from Baseline to Week 12 [Time frame: Baseline (Week 0) to Week 12]
• Change in SPADI Total Score over 12 Weeks (Longitudinal) [Time frame: 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) [Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12]
• Change in EQ-5D-5L Index Score over 12 Weeks (Longitudinal) [Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12]

Eligibility criteria

Inclusion Criteria (all must be met):

• 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.
• 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):

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 9 centers

• Yangpu District Central Hospital of Shanghai — Shanghai
• The Third Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou
• Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou
• The First People's Hospital of Linping District, Hangzhou — Hangzhou
• Huzhou Central Hospital — Huzhou
• Pujiang People's Hospital — Jinhua
• First Affiliated Hospital of Ningbo University — Ningbo
• Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group — Ningbo
• … and 1 more center

Identifiers

NCT: NCT07416916 · 2024-0434

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗