RecruitingPHASE4INTERVENTIONAL

Capsaicin in Digital Osteoarthritis Versus Control

This research is investigating whether a patch containing capsaicin, a substance found in chilli peppers, can help people with painful osteoarthritis in their hands, particularly if they also experience nerve-related pain. Participants will receive either a stronger capsaicin patch (8%) or a weaker one (0.04%). The main goal is to see if the stronger patch is better at reducing finger pain after 60 days compared to the weaker patch. The study wants to understand more about this treatment option for hand osteoarthritis, especially for those who haven't found relief from usual pain medicines.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

University Hospital, Clermont-Ferrand

Enrolment target

120

Start

07 Mar 2025

Estimated completion

01 Jan 2028

Osteoarthritis Hand Neuropathic Pain

What is this study about?

This clinical trial is designed to investigate a new way to treat pain in people with osteoarthritis in their hands, especially when they have an element of nerve pain alongside their joint pain. Osteoarthritis causes joint pain and stiffness, and sometimes, the nerves in the affected area can also become painful. The study is particularly interested in capsaicin, which is the natural chemical that gives chilli peppers their heat.

Researchers are using a skin patch that contains capsaicin. They want to find out if a stronger patch (with 8% capsaicin) is more effective at easing finger pain than a much milder patch (with 0.04% capsaicin). This stronger patch is already approved for some other types of nerve pain, but this study aims to see how well it works specifically for hand osteoarthritis with nerve pain.

The study is 'multicentric', meaning it's happening in several locations, and 'randomised controlled double-blind'. This means that participants are randomly assigned to receive either the strong or the mild patch, and neither they nor their doctors will know which one they are receiving. This helps ensure the study results are fair and unbiased. The main thing they'll be measuring is how much the pain in the fingers changes after 60 days.

Key takeaways

The study tests a capsaicin patch for hand osteoarthritis with nerve pain.
It compares a strong (8%) patch to a mild (0.04%) patch.
The main aim is to see if the strong patch reduces finger pain more after 60 days.
Participation involves a few visits over about four months and keeping a pain diary.
It's a 'double-blind' study, so you won't initially know which patch you receive.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you generally need to have been diagnosed with osteoarthritis in your fingers. You also need to be experiencing a certain level of finger pain (rated at least 4 out of 10) that also includes signs of nerve-related pain. Importantly, you should have found that usual pain relievers or anti-inflammatory drugs haven't worked well for you, or you can't take them for other reasons.

However, there are several reasons why you might not be able to take part. For example, if your hand pain is mainly due to problems at the base of your thumb (a specific condition called rhizarthrosis) or if you have other joint conditions like gout or rheumatoid arthritis affecting your fingers. You also can't join if you have skin problems on your fingers, other nerve conditions in your hand (like carpal tunnel syndrome), or certain other health issues like poorly controlled high blood pressure or fibromyalgia. The study also excludes people who have used a strong capsaicin patch recently, or have had certain injections or other pain treatments within the last few months.

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.

Do you have a diagnosis of osteoarthritis in your fingers?
Is your finger pain often 4 out of 10 or higher?
Does your finger pain feel like it has a nerve-related component (e.g., burning, tingling, shooting sensations)?
Have standard pain medicines not worked well for you, or can you not take them?
Do you have any skin problems on your fingers like eczema or open wounds?
Have you used a strong capsaicin patch in the last year or had certain injections in your joints in the last 3 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your involvement will span about four months. Firstly, there will be a 'screening' visit (Visit 0) to check if you meet all the requirements for the study. If you do, you'll then have the main 'inclusion' visit (Visit 1). At this visit, you'll be randomly assigned to receive either the stronger (8%) or weaker (0.04%) capsaicin patch, which will be applied to your hand.

You'll then have two follow-up visits. The first (Visit 2) will be around 60 days after the patch application. At this visit, your pain will be assessed, and if your finger pain is still quite high, you might have the option to receive an 'open' application of the stronger 8% capsaicin patch (meaning you and your doctors would know what you're getting). The final assessment (Visit 3) will be around 120 days after the initial patch application. Throughout the study, you'll also be asked to keep a record in a notebook of any pain relief medicines you take, anti-inflammatory drugs, steroids, and your daily hand pain levels using a simple scale.

Potential risks and benefits

Participating in this study might offer you the potential benefit of reduced hand pain if the stronger capsaicin patch is effective for your condition. However, there's also the chance you might receive the weaker patch, which may not provide as much pain relief, or either patch might not work for you. Capsaicin can cause a feeling of warmth, burning, or redness where applied, which is usually temporary. As with any medical study, there are potential risks, and not all side effects can be predicted. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

CHU de Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting
HCL Hôpital Edouard Herriot
Verified postcode
Lyon, France· Recruiting
AP-HP Hôpital Saint-Antoine
Verified postcode
Paris, France· Recruiting
CHU de Saint-Etienne
Verified postcode
Saint-Etienne, France· Recruiting

Common questions

What is capsaicin?

Capsaicin is a natural chemical found in chilli peppers that makes them feel hot. In patches, it's used to help relieve pain by affecting nerve signals.

What is 'digital osteoarthritis'?

This refers to osteoarthritis specifically affecting the joints in your fingers or thumbs, which can cause pain, stiffness, and swelling.

What does 'neuropathic pain component' mean?

It means that part of your pain is coming from damaged or irritated nerves, not just the joint itself.

Will I know if I'm getting the strong or weak patch?

No, not initially. This is a 'double-blind' study, meaning neither you nor your doctors will know which patch you received until after the main part of the study is over.

How long will the study last for me?

Your active participation, including visits and follow-up, will be spread over approximately four months.

How to find out more

Lise Laclautre

promo_interne_drci@chu-clermontferrand.fr 334.73.754.963 Official trial record

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