New study: a simple gluteal shot may be as good as Ultrasound-Guided injection for frozen shoulder
NCT ID NCT07416916
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a corticosteroid injection into the gluteal muscle works as well as an ultrasound-guided injection into the shoulder joint for treating frozen shoulder. About 528 adults aged 18 to 65 with frozen shoulder will receive one injection and be followed for 12 weeks. The goal is to see which method better improves shoulder function and reduces pain, and to compare side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 528 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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First Affiliated Hospital of Ningbo University
RECRUITINGNingbo, Zhejiang, 315020, China
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Huzhou Central Hospital
RECRUITINGHuzhou, Zhejiang, 313000, China
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Pujiang People's Hospital
NOT_YET_RECRUITINGJinhua, Zhejiang, 322200, China
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Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITINGHangzhou, Zhejiang, 310009, China
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Shengzhou People's Hospital
NOT_YET_RECRUITINGShanhu, Zhejiang, 312400, China
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The First People's Hospital of Linping District, Hangzhou
NOT_YET_RECRUITINGHangzhou, Zhejiang, 311199, China
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The Third Affiliated Hospital of Zhejiang Chinese Medical University
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310000, China
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Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group
NOT_YET_RECRUITINGNingbo, Zhejiang, 315799, China
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Yangpu District Central Hospital of Shanghai
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200082, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Muscle chain therapy put to the test for frozen shoulder
- Can radiofrequency heat thaw a frozen shoulder?
- Can retraining the brain unlock a frozen shoulder?
- Can simple exercises or TENS ease diabetic shoulder pain?
- Hormone therapy may thaw frozen shoulders faster — a trial puts it to the test
- Could a simple local anesthetic replace general anesthesia for frozen shoulder treatment?