Adhesive Capsulitis of the ShoulderPhase 3NCT06848374
Dose Efficacy in Adhesive Capsulitis
A Phase 3 study testing 40 mg Methylprednisolone and 80 mg Methylprednisolone in people with Adhesive Capsulitis of the Shoulder, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to find out if the treatment of adhesive capsulitis with 40 mg of methylprednisolone in combination with a hydrodilatation is comparable to 80 mg of methylprednisolone for pain reduction, improving shoulder mobility, and reducing side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Capsulitis of the Shoulder
- What is being tested?
- 40 mg Methylprednisolone and 80 mg Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 20 Dec 2024to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Diagnostic of adhesive capsulitis of the shoulder
Who cannot join
- Injection received in the affected shoulder < 3 months ago (any kind)
- History of previous surgery in the affected shoulder
- Glenohumeral osteoarthritis more than mild on the xray
- Pregnancy
- Blood thinner (other than Aspirin 80 mg) or bleeding disorder
- Active infection (requiring antibiotic)
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- Allergy to steroid or lidocaine
- Cognitive impairment
- Active litigation
- Inflammatory connective tissue disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Rehabilitation Institution
Toronto, Ontario, M9C 2X8
Nimish Mitta;, 416-597-3422, nimish.mittal@uhn.ca
About this study
Official title: Dose Comparison for the Treatment of Adhesive Capsulitis with Hydrodilatation and Corticosteroid Using an Anterior Approach Under Ultrasound-Guidance
The purpose of this study is to find out if the treatment of adhesive capsulitis with 40 mg of methylprednisolone in combination with a hydrodilatation is comparable to 80 mg of methylprednisolone for pain reduction, improving shoulder mobility, and reducing side effects.
Researchers will enroll 40 people in this study which is taking place solely at the Toronto Rehabilitation Institute, University Avenue. This study should take approximately 12 months to complete and the results should be known in about 15 to 18 months. During this study, patients will receive an ultrasound guided shoulder hydrodilatation combined with corticosteroid after "randomized" into one of the groups (40 mg vs 80 mg). This is a double blind study as both patients and physicians would not know the group patient was randomized to.
Pain scores, Range of Motion and few other questionnaires wold be completed to track the response to the interventions at baseline prior to injection, four weeks after the procedure and 3 months after the procedure.
- Conditions
- Adhesive Capsulitis of the Shoulder
- Being tested
- 40 mg Methylprednisolone, 80 mg Methylprednisolone
- Keywords
- Frozen shoulder, hydrodilatation
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 mg MethylprednisoloneDrug
Ultrasound guided injection of 40mg methylprednisolone injection
80 mg MethylprednisoloneDrug
Ultrasound guided injection of 40mg methylprednisolone injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 40mg methylprednisolone dose Receives: Drug: 40 mg Methylprednisolone |
| Group B | Active comparator | 80mg methylprednisolone dose Receives: Drug: 80 mg Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Scale
Change in pain scores using Numeric Pain Rating scale form baseline to 3 months
Measured: 3 months
Secondary outcomes (1)
Shoulder Pain and Disability Index score
change in pain scores using Shoulder Pain and Disability Index score form baseline to 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start20 Dec 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis of the ShoulderStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nimish Mittal, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848374
- Sponsor's protocol ID
- 24-5123
- Status last verified
- Feb 2025
- First submitted
- 8 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Comparison for the Treatment of Adhesive Capsulitis with Hydrodilatation and Corticosteroid Using an Anterior Approach Under Ultrasound-Guidance
- ClinicalTrials.gov ID
- NCT06848374
- Acronym / sponsor ID
- 24-5123
- Conditions
- Adhesive Capsulitis of the Shoulder
- Keywords
- Frozen shoulder, hydrodilatation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if the treatment of adhesive capsulitis with 40 mg of methylprednisolone in combination with a hydrodilatation is comparable to 80 mg of methylprednisolone for pain reduction, improving shoulder mobility, and reducing side effects.
Researchers will enroll 40 people in this study which is taking place solely at the Toronto Rehabilitation Institute, University Avenue. This study should take approximately 12 months to complete and the results should be known in about 15 to 18 months. During this study, patients will receive an ultrasound guided shoulder hydrodilatation combined with corticosteroid after "randomized" into one of the groups (40 mg vs 80 mg). This is a double blind study as both patients and physicians would not know the group patient was randomized to.
Pain scores, Range of Motion and few other questionnaires wold be completed to track the response to the interventions at baseline prior to injection, four weeks after the procedure and 3 months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: 40 mg Methylprednisolone40mg methylprednisolone dose |
| Group B | Active comparator | Drug: 80 mg Methylprednisolone80mg methylprednisolone dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years of age
- Diagnostic of adhesive capsulitis of the shoulder
Key exclusion criteria (10 listed)
- Injection received in the affected shoulder < 3 months ago (any kind)
- History of previous surgery in the affected shoulder
- Glenohumeral osteoarthritis more than mild on the xray
- Pregnancy
- Blood thinner (other than Aspirin 80 mg) or bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40 mg MethylprednisoloneUltrasound guided injection of 40mg methylprednisolone injection | Drug | Group A |
| 80 mg MethylprednisoloneUltrasound guided injection of 40mg methylprednisolone injection | Drug | Group B |
Primary outcome
Numeric Pain Scale
Time frame: 3 months
Change in pain scores using Numeric Pain Rating scale form baseline to 3 months
1 secondary outcome
Shoulder Pain and Disability Index score
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 40 mg Methylprednisolone and 80 mg Methylprednisolone in people with Adhesive Capsulitis of the Shoulder, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nimish Mittal (416-597-3422, nimish.mittal@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.