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Frozen shoulder breakthrough? injection combo shows promise in small study

NCT ID NCT04653636

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looked at 55 adults with severe frozen shoulder (pain and stiffness for at least 3 months) who had not improved with standard treatments. They received one to three injections of steroid and numbing medicine into the shoulder joint, followed by intensive physiotherapy. The goal was to find out which patients respond best, based on MRI and clinical factors, with pain and function measured after one month.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
corticosteroid injection (betamethasone or triamcinolone hexacetonide) with lidocaine and saline
What this could lead to
If successful, this could help identify which patients with severe frozen shoulder benefit most from this injection-plus-physiotherapy approach, leading to more personalized treatment.
What could go wrong
This is a small, completed study (55 people) looking for predictive factors, not a large trial testing effectiveness. Results may not apply to all patients, and the procedure carries risks like infection or temporary pain increase.

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.

Participants

55 people

The number who actually took part.

Started

Oct 2020

Finished

Nov 2022

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.

Who is studied

Patients presenting to the physical medicine and rehabilitation department \[tertiary care\] of Cochin Hospital with a clinically diagnosis of severe adhesive capsulitis for whom first-line medical treatment is not effective.

Ages

18 years and older

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: * Age greater than or equal to 18 years, * Symptomatic shoulder (pain or stiffness) for at least 3 months. * Patient with failure of treatment including at least NSAIDs, analgesics, +/- intra-articular corticosteroid infiltration and physiotherapy. * Painful shoulder at inclusion (EN \> 5) * Limitation of passive amplitudes of the glenohumeral joint, of at least 25% of 2 of the 3 mobility sectors (lateral arm elevation, anterior elevation and lateral rotation in the RE1 position), compared to the opposite side * Absence of glenohumeral arthropathy and abarticular calcification on the standard x-ray of both shoulders. * Affiliation to a social security * Information and collection of patient consent Exclusion Criteria * Obtain patient consent impossible * Cognitive disorders considered moderate to severe by the investigator * Unbalanced diabetes mellitus (glycated hemoglobin\> 10%) * Anticoagulant treatment that cannot be interrupted * Hemostatic disorders (known history, platelet count \<120,000, prothrombin level \<75%) * Allergy to xylocaine, Gadolinium, Diprostene * Biological inflammatory syndrome * Pregnant woman (beta human chorionic gonadotropin dosage) or breastfeeding * Language barrier to the integration of a rehabilitation program or the performance of a reliable assessment. * People under protective measures * Refusal to participate

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Conditions

The condition(s) this trial relates to.

bursitis frozen shoulder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adhesive capsulitis

Contacts and locations

Locations

  • Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis

    Paris, IDF, 75014, France

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