Active not recruitingPHASE2INTERVENTIONAL

Peripheral Nerve Injections for CRPS

This study is for people in the UK with a type of long-lasting pain called Complex Regional Pain Syndrome (CRPS) in their arm or hand. CRPS can cause severe pain, swelling, and difficulty moving. Current treatments aren't always very effective. This research explores if injections near specific nerves in the arm, containing a pain-relieving medicine (bupivacaine) and a steroid (triamcinolone acetonide), can help reduce pain. We already know nerve blocks can help with other pain conditions, and a small study showed promising results for CRPS. This is a Phase 2 study, meaning it's an important step to check if this treatment is safe and if it works well enough to be tested in a much bigger study later on. Participants will receive either the active injection or a dummy injection (saline) as part of a careful comparison.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Ottawa Hospital Research Institute

Enrolment target

Start

30 May 2024

Estimated completion

01 Jun 2025

Complex Regional Pain Syndromes

What is this study about?

Complex Regional Pain Syndrome (CRPS) is a challenging condition that causes severe, ongoing pain, often in an arm or leg. Along with pain, people might experience changes in skin temperature or colour, swelling, and difficulty moving the affected limb. It can significantly impact daily life, and for many, finding a treatment that truly helps can be difficult. This study focuses specifically on CRPS affecting the arm or hand.

Researchers are investigating whether injections close to certain nerves in the arm can help manage CRPS pain. These injections would contain a common pain-numbing medicine called bupivacaine, along with a steroid called triamcinolone acetonide, which can help reduce inflammation. The idea is that by blocking pain signals travelling along these nerves, we might be able to lessen the severe pain of CRPS and potentially improve how the arm functions. Doctors have used similar nerve blocking techniques successfully for other painful conditions.

This is a 'Phase 2' study, which is an important step in developing new treatments. It's not a full test of whether the treatment works in lots of people yet. Instead, it's designed to gather key information to help plan a much larger study in the future. For example, the researchers will look at how easy it is to find people for the study, if they stay involved, and if the treatment causes any side effects. This careful preparation ensures that any future, larger trial can be run effectively and safely.

Key takeaways

The study tests nerve injections for arm/hand CRPS pain.
It's a Phase 2 study, aiming to prepare for a larger trial.
Participants will receive either active treatment or a dummy injection.
All usual CRPS care will continue alongside the study.
The study is investigating pain reduction and safety.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have been diagnosed with Complex Regional Pain Syndrome (CRPS) in your arm or hand, following specific criteria called the Budapest criteria. Your pain in the affected arm or hand must also be at a certain level – at least 40 on a scale of 0 to 100, where 0 is no pain and 100 is the worst imaginable pain. You must also be able to understand the study and provide your written permission to take part.

There are several reasons why you might not be able to join the study. For example, if you have very high blood pressure that isn't under control, certain serious infections, a condition that makes you bleed easily, or active cancer, you wouldn't be eligible. The study also cannot include pregnant or breastfeeding individuals.

In addition, conditions like certain brain injuries, severe difficulties with language or thinking (like a very low score on a memory test), or specific mental health concerns that are not being treated would prevent participation. The study aims to be as safe as possible for everyone involved, so these checks are important.

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.

Am I at least 18 years old?
Do I have a diagnosis of CRPS in my arm or hand?
Is my arm/hand pain severe enough (at least 40/100 on a pain scale)?
Am I pregnant or breastfeeding?
Do I have very high blood pressure or certain other serious health issues?
Can I understand the study and give written permission to join?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have a screening visit to make sure you meet all the study requirements. If you're eligible, you would then be randomly assigned to receive either the active treatment injection (containing the pain medicine and steroid) or a 'dummy' injection (containing saline, which is just salty water). You wouldn't know which one you're getting, and neither would the study doctors, to make the results as fair as possible.

All participants will continue to receive the usual care for CRPS that they would normally get. The treatment itself involves injections near specific nerves in your arm. Researchers will carefully check how you are doing, including your pain levels and any side effects, at various points after the injection. The study will involve several visits to the clinic for these assessments. The total number of planned visits or the exact duration of your participation isn't fully detailed here, but generally, studies like this involve follow-up over several weeks to months.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that the active treatment might help reduce your CRPS pain and improve the function of your arm. However, because you might receive a dummy injection, there's also a chance you won't get the active treatment. Possible risks with injections can include pain or bruising at the injection site, and side effects from the medications, though they are usually mild. The researchers will be closely monitoring you for any side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

The Ottawa Hospital
Verified postcode
Ottawa, Canada
Elisabeth Bruyere Hospital
Verified postcode
Ottawa, Canada

Common questions

What is CRPS?

CRPS stands for Complex Regional Pain Syndrome. It's a type of ongoing pain, often in an arm or leg, that can cause severe pain, swelling, and difficulty moving.

What kind of treatment will I get?

You'll get an injection near nerves in your arm. It will either contain a pain-numbing medicine and a steroid, or a dummy injection (saline).

Will I know if I'm getting the real medicine or the dummy shot?

No, neither you nor the study doctors will know which injection you're receiving. This helps make the study results fair and accurate.

How long will I be in the study?

The information provided doesn't state the exact duration, but studies like this usually involve follow-up visits over several weeks or months to check on your progress.

Can I leave the study at any time?

Yes, you are free to stop participating in the study at any point, and it won't affect your medical care.