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Frozen shoulder showdown: which treatment wins?

NCT ID NCT07409779

Symptom relief Sponsor: Faculty of Medicine of Tunis 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two common treatments for frozen shoulder (adhesive capsulitis): a procedure that stretches the shoulder joint capsule (capsular distension) and a steroid injection. Both are followed by a rehab program. The trial will measure pain, movement, and disability in 50 adults aged 18-80 to see which approach works better.

What this could mean

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

Active substance
Betamethasone (Diprostene®) injection and capsular distension procedure
What this could lead to
If this trial succeeds, it could show which treatment—capsular distension or steroid injection—works better for frozen shoulder, helping doctors choose the best option.
What could go wrong
This is a small, early-stage trial with only 50 people, so results may not apply to everyone. Both treatments have risks like infection or temporary pain, and one may not be clearly better.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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 80 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: * Age between 18 and 80 years * Ability to provide informed consent * Shoulder pain with Visual Analog Scale (VAS) ≥ 40/100 * Limitation of external rotation \< 45° or \< 50% compared to the contralateral side * Clinically diagnosed adhesive capsulitis with normal shoulder radiography Exclusion Criteria: * Rotator cuff tear * Previous shoulder surgery * Cervico-brachial neuralgia * Pregnancy or breastfeeding * Poorly controlled diabetes * Coagulation disorders or anticoagulant therapy with INR \> 3 * Allergy to lidocaine * Inflammatory rheumatic diseases * Severe cardiovascular or hematological diseases * Active infection or immunodeficiency * Severe psychiatric disorders * Recent shoulder rehabilitation (within 1 week) * Intra-articular corticosteroid injection or hyaluronic acid injection within the last 6 months * Refusal to sign informed consent

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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 of the shoulder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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

  • Faculty of Medecine of Tunis

    Tunis, Tunis Governorate, Tunisia

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