Ongoing, recruitingTherapeutic use (Phase IV)Interventional

The effect of perineural botox on chronic cutaneous neuropathic pain

This study is investigating if Botox injections given near nerves can help people suffering from long-lasting nerve pain, a condition called neuropathy. We want to find out if Botox can reduce their pain. The research compares Botox with a simple saltwater injection (a placebo) to see which is more effective. We'll be looking at how many people feel their pain has become mild, moderate, or good after four weeks. We're also checking how much pain changes overall, how it affects sleep and daily activities, and if people are happy with the treatment. The goal is to see if Botox could be a helpful option for managing this type of pain.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Aarhus Universitetshospital

Enrolment target

Start

16 Oct 2023

Neuropathy

What is this study about?

This study is looking into a different way to treat chronic neuropathic pain, which is ongoing pain caused by damage or irritation to nerves. Imagine your nerves are like electrical wires carrying messages to your brain; when they're damaged, they can send pain signals all the time. This type of pain can be very difficult to live with and can affect your daily life.

The researchers are testing if injecting a small amount of Botox around these sensitive nerves can help calm them down and reduce the pain. Botox is often known for its cosmetic uses, but it's also used in small doses to treat various medical conditions, including certain types of muscle spasms and headaches. In this study, they're exploring its potential for nerve pain.

To make sure the results are reliable, some participants will receive the active Botox treatment, while others will receive a 'dummy' injection (called a placebo) which contains only salt water. This helps the researchers understand if any improvements are genuinely due to the Botox or simply to the expectation of treatment. They will be carefully watching how participants feel over four weeks, focusing on how much their pain has lessened.

Key takeaways

This study explores Botox for chronic nerve pain.
It compares Botox to a placebo (dummy injection).
Adults 18+ with nerve pain are needed.
Pain relief, satisfaction, and side effects are being checked.
Results could help future treatments for nerve pain.

Who may be eligible?

This study is looking for adults aged 18 and over, whether they are male or female. The main requirement for joining is that you have chronic neuropathic pain, meaning you have ongoing pain caused by nerve damage or irritation.

The researchers will need to make sure this study is the right fit for you. They will check your medical history to ensure that taking part is safe and that nothing else might affect the results of the treatment. This helps them understand who might benefit most from this type of treatment.

It's important to talk to the study team or your doctor to find out all the specific details about joining. They can explain if your particular situation matches what they are looking for in participants.

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?
Do you have ongoing pain caused by nerve damage (neuropathic pain)?
Are you able to attend study visits as required?
Are you willing to potentially receive either Botox or a saltwater injection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits with the study team. At these visits, you will receive an injection. This injection will either contain Botox or a simple saltwater solution (a placebo). You won't know which one you receive, as this helps the researchers get unbiased results.

Over the course of the study, you'll be asked about your pain levels, how well you're sleeping, and how active you are. This will usually involve filling out questionnaires about your symptoms and how you feel. The main follow-up period will be four weeks after your injection, but the research team will monitor you throughout the study to track any changes or side effects. The total duration of your participation will be explained by the study team.

Potential risks and benefits

Taking part in this study may or may not directly benefit you, but the information gained could help others with similar conditions in the future. Potential benefits include the possibility that the Botox injection might reduce your pain. However, there are also potential risks, such as temporary pain or bruising at the injection site, or other side effects associated with Botox, which the study team will explain in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is 'neuropathic pain'?

Neuropathic pain is a type of long-lasting pain caused by damage or irritation to your nerves.

What is Botox, and why are they using it for pain?

Botox is a medicine that can relax muscles or block certain nerve signals. Researchers are exploring if it can calm overactive nerves causing pain.

Will I know if I'm getting Botox or a dummy injection?

No, you won't know directly. This helps ensure the study results are fair and accurate.

How long will the study last for me?

The main follow-up is four weeks after the injection, but the study team will tell you the full timeline for your involvement.

What does 'Phase IV' mean for a study?

Phase IV means the treatment is already approved for other uses, and researchers are now studying it for a new purpose or to learn more about it.