RecruitingOBSERVATIONAL

Response Profiles to High-concentration Capsaicin Desensitization in Patients with Peripheral Neuropathic Pain with or Without Allodynia: a Regional Multicenter Prospective Cohort

This study is investigating how people with ongoing nerve pain react to a treatment that uses a high-strength capsaicin patch. Capsaicin is the ingredient that makes chilli peppers hot. The patch works by reducing the sensitivity of the nerves that cause pain. Researchers want to understand what makes some patients respond better to this treatment than others. This includes looking at factors like whether they have 'allodynia', which is when light touch or everyday things like clothing cause pain. The study involves patients in the Auvergne Rhône Alpes region in France and will follow them over time to see how well the treatment works for their nerve pain.

At a glance

Status

Recruiting

Sponsor

Centre Hospitalier Annecy Genevois

Enrolment target

400

Start

14 Dec 2023

Estimated completion

15 Jun 2026

Peripheral Neuropathic Pain

What is this study about?

This research study is about helping people who suffer from a type of long-lasting pain called peripheral neuropathic pain, or simply nerve pain. This kind of pain happens when there's damage to your nerves, which can make even light touches feel painful. The study is specifically looking at a treatment that uses a high-dose capsaicin patch. Capsaicin is the natural substance found in chilli peppers that gives them their heat. In this patch, it's used in a way that helps to 'desensitize' overactive nerves, which can reduce pain.

The main goal of this study is to figure out why some people with nerve pain respond really well to this capsaicin patch, while others don't get as much relief. The researchers are especially interested in whether having something called 'allodynia' makes a difference. Allodynia means that you feel pain from things that shouldn't normally hurt, like a gentle brush of clothing, or mild heat or cold.

By carefully observing a group of patients over time, the researchers hope to identify specific characteristics or 'patient profiles' that are linked to a better response to the capsaicin treatment. This information could eventually help doctors decide which patients are most likely to benefit from this type of patch, leading to more effective pain management for those with nerve pain.

Key takeaways

This study helps us understand who benefits most from capsaicin patches for nerve pain.
It looks at factors like 'allodynia' (pain from light touch).
You won't get any new medicines; it observes your response to standard treatment.
Participation involves answering questionnaires and having your pain checked.
The findings could help doctors better choose treatments for nerve pain.
All study information will be in French.

Who may be eligible?

To be part of this study, you need to be an adult aged 18 or older. You must have nerve pain that has been carefully checked by your doctor, scoring at least 4 out of 10 on a special pain questionnaire (called DN4) and also on a regular pain scale. Your current pain medication should have been stable for at least one month, meaning you haven't recently changed doses or started new pain medicines.

Crucially, you would be considered for this study if your doctor thinks the high-strength capsaicin patch is a suitable treatment for your nerve pain and you haven't used this type of capsaicin patch on the affected area before. Also, you need to be able to understand French to participate, as the study materials and communication will be in French.

There are some reasons why you wouldn't be able to join. For example, if you have a certain type of pain condition called complex regional pain syndrome, active cancer, or have had Botox injections for pain in the last three months in the area being treated. You also can't join if you're planning to have surgery on your painful area within the next year, or if you're already in another research study. People under legal guardianship are also not able to take part.

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 nerve pain that your doctor has diagnosed as suitable for a high-strength capsaicin patch?
Have you been on a stable dose of your current pain medicines for at least one month?
Have you NOT had a high-strength capsaicin patch on the affected area before?
Are you able to speak and understand French?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be given any new medicines. Instead, the study will involve answering some questionnaires about your pain and how you respond to the capsaicin patch treatment that your doctor has already decided is right for you. Your doctor will assess your pain levels and feelings using special tests, including specific ways to check for skin sensitivity to touch, heat, or cold. The study team will then follow your progress over time. The exact number of visits or the total length of your participation isn't specified, but it will involve keeping track of your pain and responses after getting the capsaicin patch.

Potential risks and benefits

There are no new experimental treatments in this study, as you'll be receiving the capsaicin patch treatment your doctor would recommend anyway. The main benefit of participating is helping researchers better understand who responds best to this nerve pain treatment, which could lead to improved care for others in the future. As with any medical procedure, there's always a small chance of side effects from the capsaicin patch itself, such as temporary burning or redness. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (10)

Centre Hospitalier Annecy Genevois
Verified postcode
Annecy, France· Recruiting
Hospices Civils de Lyon, Hôpital Pierre Wertheimer
Verified postcode
Bron, France· Not yet recruiting
Centre Hospitalier Métropole Savoie
Verified postcode
Chambéry, France· Recruiting
Centre Hospitalier Universitaire de Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Not yet recruiting
Centre Hospitalier Universitaire Grenoble-Alpes
Verified postcode
Grenoble, France· Recruiting
Hospices Civils de Lyon, Hôpital de la Croix Rousse
Verified postcode
Lyon, France· Not yet recruiting
Centre Léon Bérard
Verified postcode
Lyon, France· Recruiting
Centre Hospitalier Universitaire de Saint-Etienne
Verified postcode
Saint-Etienne, France· Not yet recruiting
Clinique Mutualiste Chirurgicale de Saint Etienne
Verified postcode
Saint-Etienne, France· Recruiting
Médipôle Lyon Villeurbanne
Verified postcode
Villeurbanne, France· Not yet recruiting

Common questions

What is peripheral neuropathic pain?

It's a type of long-lasting pain caused by damage to your nerves. It can feel like burning, shooting, or electric shock sensations.

What is capsaicin?

Capsaicin is the natural substance in chilli peppers that makes them hot. In a patch, a high dose can help reduce nerve pain by making the nerves less sensitive.

What is allodynia?

Allodynia is when you feel pain from things that shouldn't normally be painful, like a light touch, a brush of clothing, or mild changes in temperature.

Will I have to take new medicine in this study?

No, you won't be given any new or experimental medicines. You'll receive the capsaicin patch treatment that your doctor has already decided is right for you.

How long will I be in the study?

The study does not specify an exact duration, but it involves following your progress over time after you receive the capsaicin patch treatment.

How to find out more

Marion GHIDI

drci.promotion@ch-annecygenevois.fr +33450637031 Official trial record

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