RecruitingNAINTERVENTIONAL

Prednisone for CRPS in Distal Radius Fracture

This study is investigating if a short course of prednisone, an anti-inflammatory medicine, can help prevent a painful condition called Complex Regional Pain Syndrome (CRPS) in people who have broken their wrist. Wrist fractures are very common. CRPS can cause long-term pain and disability, and it can also lead to more reliance on strong pain medications like opioids. Researchers want to see if giving prednisone for two weeks after wrist fracture surgery, compared to a dummy pill (placebo), can reduce CRPS, lower the need for opioids, and lead to better recovery. They will also check if it's practical to run a larger study like this in the future.

At a glance

Status

Recruiting

Phase

Sponsor

University of British Columbia

Enrolment target

Start

10 Oct 2024

Estimated completion

01 Jul 2027

Complex Regional Pain Syndromes Distal Radius Fractures

What is this study about?

Broken wrists are a very common injury. Sometimes, after a wrist fracture, a complication called Complex Regional Pain Syndrome (CRPS) can develop. CRPS can cause severe and long-lasting pain, and make it difficult to use your hand and arm properly, potentially leading to permanent problems. It can also mean people need to use more strong pain medicines, known as opioids, which doctors are trying to reduce because of concerns about addiction.

Currently, there isn't a lot of strong research about the best way to prevent or treat CRPS early on. However, some smaller studies have suggested that anti-inflammatory medicines, like prednisone, might be helpful. This study wants to find out if giving prednisone for a short time after wrist surgery could be a good early treatment strategy.

This study will look at people who have had a wrist fracture and needed surgery. Some will receive prednisone for two weeks, while others will receive a dummy pill (placebo) – neither you nor your doctor will know which you are getting. The doctors will then compare how both groups recover, looking at things like pain levels, whether CRPS develops, and how much pain medication is needed over six months. This will help them decide if a bigger study should be done in the future.

Key takeaways

This study explores a potential early treatment for CRPS after wrist fractures.
It tests an anti-inflammatory medicine called prednisone against a dummy pill (placebo).
Participation involves taking tablets for two weeks and having follow-up assessments for six months.
The goal is to see if prednisone can reduce pain, prevent CRPS, and lower opioid use.
Scientists also want to check if this type of study can be done on a larger scale in the future.

Who may be eligible?

To be considered for this study, you need to be at least 19 years old and have recently broken one of your wrist bones (distal radius fracture) within the last three weeks. This break must be simple, meaning not open or complicated, and you must be having surgery to fix it with a specific type of plate.

You would also need to show some early signs that you might be at a higher risk of developing CRPS, such as having significant pain for more than a week after your injury, or scoring above a certain level on a depression screening. You also need to meet specific criteria for developing CRPS based on a medical assessment. Importantly, you cannot be pregnant, breastfeeding, or planning to become pregnant.

There are several reasons you might not be able to join. For example, if you've broken the same wrist before, have other serious injuries, have certain medical conditions like diabetes, or an active infection. You also can't be allergic to prednisone or related medications, or already be taking similar anti-inflammatory medicines. The study team will review all these points with you to see if it's the right fit.

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 19 years old or older?
Have you recently (within 3 weeks) broken one of your wrist bones and are having surgery?
Do you have significant pain in your wrist for over a week, or other signs making you more likely to develop CRPS?
Are you NOT pregnant, breastfeeding, or planning to become pregnant?
Are you NOT allergic to prednisone or similar medications?
Do you NOT have diabetes or an active infection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first give your informed consent, which means you understand what's involved and agree to participate. You would then be randomly assigned to either receive prednisone tablets or a placebo (dummy) tablet for two weeks after your wrist surgery. This means you have an equal chance of receiving either medicine, and neither you nor your doctors will know which one you are taking until the study ends. Throughout the study, doctors will carry out clinical assessments, which are likely to include checking your pain levels, how well your wrist is healing, and asking about any other symptoms or medications you are taking, particularly pain relievers. They will also be looking for any side effects from the medication. Your participation would involve these assessments for six months following your injury.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of receiving an early treatment that might prevent or lessen the severity of CRPS, a painful complication after a broken wrist. However, like all medications, prednisone can have side effects, and some people might experience them. You also might be assigned to receive a placebo, which means you wouldn't be getting the active medication being tested. You will be closely monitored for any adverse effects regardless of which group you are in. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Vancouver General Hospital
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is CRPS?

CRPS, or Complex Regional Pain Syndrome, is a painful condition that can sometimes develop after an injury, like a broken wrist. It causes ongoing pain, swelling, and changes in the affected limb.

What is prednisone?

Prednisone is a medicine often used to reduce inflammation and pain in the body. It’s a type of steroid, but it's important to know it's different from the steroids some athletes misuse.

Will I know if I'm getting prednisone or the placebo?

No, you won't know if you're receiving prednisone or the dummy pill (placebo). This helps make the study results fair and accurate, as your expectations won't influence how you report symptoms.

How long will I be in the study?

You would be in the study for six months after your wrist injury, with the prednisone or placebo taken for the first two weeks after surgery.

What are opioids and why is the study looking at them?

Opioids are strong painkiller medications. The study wants to see if prednisone might reduce the amount of opioids people need, as there are concerns about long-term use of these medications.

How to find out more

David Stockton, MD, MASc, FRCSC

david.stockton@vch.ca 604-875-5809 Official trial record

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