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New study: a simple gluteal shot may be as good as Ultrasound-Guided injection for frozen shoulder

NCT ID NCT07416916

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 528 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • First Affiliated Hospital of Ningbo University

    RECRUITING

    Ningbo, Zhejiang, 315020, China

  • Huzhou Central Hospital

    RECRUITING

    Huzhou, Zhejiang, 313000, China

  • Pujiang People's Hospital

    NOT_YET_RECRUITING

    Jinhua, Zhejiang, 322200, China

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

  • Shengzhou People's Hospital

    NOT_YET_RECRUITING

    Shanhu, Zhejiang, 312400, China

  • The First People's Hospital of Linping District, Hangzhou

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 311199, China

  • The Third Affiliated Hospital of Zhejiang Chinese Medical University

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group

    NOT_YET_RECRUITING

    Ningbo, Zhejiang, 315799, China

  • Yangpu District Central Hospital of Shanghai

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200082, China

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