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Compares treatment options for Frozen Shoulder
Official title Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
ClinicalTrials.gov ID: NCT07416916
What this study is testing
What is Compound betamethasone injection (dorsogluteal intramuscular)?
Compound betamethasone injection (dorsogluteal intramuscular) is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for frozen shoulder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- (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...
You likely can't join if
- (any of the following):
- Secondary frozen shoulder due to thyroid disease, cardiovascular disease, stroke, radiotherapy, prior neurosurgical or breast surgery, etc. (diabetes...
- Confirmed or highly suspected full-thickness or massive rotator cuff tear causing functional pseudoparalysis (e.g., positive Jobe test with marked...
- 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.
See the full eligibility 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...
- Radiographic exclusion of other shoulder pathology: Affected-shoulder anteroposterior (AP) radiograph excludes glenohumeral osteoarthritis, calcific tendinopathy, and other structural abnormalities; and axillary view...
- (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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
- Huzhou, Zhejiang, China
- Jinhua, Zhejiang, China
- Ningbo, Zhejiang, China
- Shanhu, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China; Hangzhou, Zhejiang, China; Huzhou, Zhejiang, China; Jinhua, Zhejiang, China; Ningbo, Zhejiang, China; Shanhu, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.