RecruitingPHASE3INTERVENTIONAL

Dose Efficacy in Adhesive Capsulitis

This study is investigating the best dose of a steroid injection, called methylprednisolone, for treating frozen shoulder, also known as adhesive capsulitis. Researchers want to find out if 40mg of methylprednisolone works as well as 80mg to reduce pain, improve how much you can move your shoulder, and cause fewer side effects. Both doses are given with a special fluid injection called hydrodilatation. Forty people will take part in this study at the Toronto Rehabilitation Institute. You wouldn't know which dose you're getting, and neither would your doctor. They will check your pain and movement before the injection, then again after 4 weeks and 3 months, to see how well the treatment worked.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University Health Network, Toronto

Enrolment target

Start

20 Dec 2024

Estimated completion

31 Dec 2026

Adhesive Capsulitis of the Shoulder

What is this study about?

This study is looking into a condition called 'frozen shoulder', which doctors call adhesive capsulitis. It's when your shoulder becomes painful and stiff, making it hard to move your arm normally. The study is comparing two different strengths of a steroid medicine, methylprednisolone, which is given as an injection into the shoulder. One group of people will receive a 40mg dose, and another group will receive an 80mg dose. This steroid injection is given along with a procedure called hydrodilatation, where a fluid is also injected into the shoulder joint.

The main goal of this research is to see if the lower dose (40mg) of methylprednisolone is just as good, or even better, than the higher dose (80mg) at easing pain and helping people move their shoulder more freely. The researchers also want to monitor if one dose causes more side effects than the other. Finding an effective dose with fewer side effects is always important in medicine.

This study is happening at the Toronto Rehabilitation Institute and will involve 40 people. It's designed so that neither you nor your doctor will know which dose you've received. This helps make the results fairer and more reliable. The study will last about a year to complete, and the results should be available a few months after that, helping doctors understand the best way to treat frozen shoulder in the future.

Key takeaways

The study compares two doses (40mg vs 80mg) of steroid injection for frozen shoulder.
It aims to find the best dose for reducing pain and improving shoulder movement.
The injection includes a special fluid treatment called hydrodilatation.
Neither you nor your doctor will know which dose you receive.
Your pain and movement will be checked before, then at 4 weeks and 3 months after the injection.
Your involvement will last about three months in total.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with frozen shoulder (adhesive capsulitis).

There are some reasons why you might not be able to join. For example, if you've had any kind of injection in your affected shoulder in the last three months, or if you've had surgery on that shoulder before. Also, if you have severe arthritis in your shoulder joint, or if you are pregnant, this study wouldn't be suitable for you.

Other reasons to not be able to take part include if you're taking blood thinners (other than a low dose of aspirin), have a bleeding problem, a current infection needing antibiotics, allergies to steroids or certain local anaesthetics, or if you have certain other medical conditions affecting your connective tissue. People with difficulty understanding instructions or who are currently involved in legal action related to their shoulder injury also can't participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with frozen shoulder?
Have you had any injection in your affected shoulder in the last 3 months?
Have you had surgery on your affected shoulder before?
Are you pregnant or trying to get pregnant?
Are you allergic to steroids or numbing medicines like lidocaine?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first have an initial visit where your pain and shoulder movement will be assessed. You will then be randomly assigned to one of two groups; one group will receive a 40mg dose of methylprednisolone, and the other will receive an 80mg dose. You, and your doctors, will not know which dose you are receiving. The steroid will be injected into your shoulder joint along with a fluid, guided by ultrasound to ensure it goes into the correct place.

After the injection, you will have follow-up visits. Your pain levels, shoulder movement, and other questionnaires will be completed at four weeks and again at three months after your injection. The entire study process for you, from your first visit to your last follow-up, will take about three months. The researchers expect the full study to take about 12 months to enroll all participants and about 15-18 months overall until the results are known.

Potential risks and benefits

Participating in this study might offer you the benefit of receiving an active treatment for your frozen shoulder, potentially reducing your pain and improving your shoulder movement. However, as with any medical procedure, there are potential risks, such as local pain or bruising from the injection, or very rarely, infection or other side effects related to the steroid. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Toronto Rehabilitation Institution
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is 'frozen shoulder'?

Frozen shoulder, also called adhesive capsulitis, is a condition where your shoulder becomes very stiff and painful, making it hard to move your arm normally.

What is methylprednisolone?

Methylprednisolone is a type of steroid medicine that helps reduce swelling and pain. It's given as an injection into the affected joint.

What is hydrodilatation?

Hydrodilatation is a procedure where a fluid is injected into your shoulder joint to help stretch the joint capsule and improve movement, often combined with a steroid.

What does 'double blind' mean in a study?

It means that neither you, the patient, nor your doctor will know which treatment dose you are receiving. This helps make the study results fair and unbiased.

How long will I be involved in the study?

From your first visit to your last follow-up, your personal involvement in the study will last about three months.

How to find out more

Nimish Mittal

nimish.mittal@uhn.ca 416-597-3422 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.