Study on Capsaicin for Finger Pain in Digital Osteoarthritis Patients

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for digital osteoarthritis, a condition that affects the joints in the fingers, causing pain and stiffness. The study will use a treatment called Qutenza, which is a patch containing capsaicin, a substance known for its pain-relieving properties. Capsaicin is the active ingredient in the patch, and it is applied directly to the skin over the affected area. The study will compare the effectiveness of a high-dose capsaicin patch (8%) to a low-dose capsaicin patch (0.04%) in reducing finger pain.

The purpose of the study is to determine how well the capsaicin patch works in relieving pain in patients with digital osteoarthritis, especially those who experience a type of pain known as neuropathic pain, which is caused by nerve damage. Participants in the study will receive either the high-dose or low-dose patch, and their pain levels will be monitored over a period of eight weeks. The study aims to see if the higher dose of capsaicin provides better pain relief compared to the lower dose.

Throughout the study, participants will have their finger pain assessed using a visual scale that measures pain intensity. This will help researchers understand the effectiveness of the capsaicin treatment in managing pain associated with digital osteoarthritis. The study is designed to provide valuable information on whether the capsaicin patch can be a beneficial treatment option for those suffering from this painful condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, diagnosis of digital osteoarthritis, and the presence of finger pain.

Informed consent is signed, and study information is provided for understanding.

2 initial assessment

An initial assessment is conducted to measure the intensity of finger pain using a visual analog scale (VAS) ranging from 0 to 100 mm.

This assessment helps establish a baseline for future comparisons.

3 treatment administration

The treatment involves the application of a cutaneous patch containing capsaicin.

Two types of patches are used: one with a high dose of capsaicin (8%) and another with a low dose (0.04%) as a control.

The patch is applied to the skin, specifically for cutaneous use, to manage finger pain associated with digital osteoarthritis.

4 treatment duration

The treatment is administered over a period of eight weeks.

During this time, the effectiveness of the capsaicin patch in reducing finger pain is monitored.

5 final assessment

At the end of the eight-week period, a final assessment is conducted to measure the intensity of finger pain using the VAS.

The results are compared to the initial assessment to evaluate the effectiveness of the treatment.

Who Can Join the Study?

Must be 18 years or older.
Must have a diagnosis of digital osteoarthritis. This is a type of arthritis affecting the fingers, diagnosed according to specific medical guidelines.
Must experience finger pain that is at least 40 mm on a Visual Analogue Scale (VAS). This scale is a way to measure pain intensity.
Must have finger pain with a neuropathic component. This means the pain is related to nerve damage or dysfunction, measured by a DN4 score of 4 out of 10 or higher.
Must have had an inadequate response, side effects, or cannot use traditional painkillers and NSAIDs. NSAIDs are non-steroidal anti-inflammatory drugs, a common type of pain relief medication.
Must be able to read and understand the information about the study.
Must have signed informed consent. This means agreeing to participate after understanding the study details.
Must be affiliated with a social security scheme. This means having some form of health insurance or social security coverage.
Women of childbearing age must use effective contraception, such as the pill, contraceptive implant, IUD, condoms, or have had a tubal ligation, for the entire duration of the trial.

Who Cannot Join the Study?

Patients who are not experiencing finger pain due to digital osteoarthritis. Digital osteoarthritis is a condition that affects the joints in the fingers.
Patients who do not have a neuropathic pain component. Neuropathic pain is a type of pain that happens when there is damage to the nerves.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Hospital Edouard Herriot	Lyon	France
Imsghqsp dk Cidbvgxbbjcm Hzkecukrosy Uzfwhqeqmbtzb dx Sbfhb Eekkdnr (rdovnrv	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	31.05.2024

Trial locations

Investigated drugs:

Capsaicin

Capsaicin 8% is a medication used in this trial to help reduce finger pain in patients with digital osteoarthritis. It is applied to the skin and works by affecting the nerves that send pain signals, potentially providing relief from pain associated with osteoarthritis.

Low Dose Capsaicin 0.04% is used as a control in this study. It is also applied to the skin but contains a much lower concentration of capsaicin. This helps researchers compare the effects of the higher dose capsaicin to see if it is more effective in reducing pain.

Digital Osteoarthritis – Digital osteoarthritis is a form of arthritis that affects the joints in the fingers. It is characterized by the breakdown of cartilage, which leads to pain, swelling, and stiffness in the affected joints. Over time, the joints may become deformed, and movement can become limited. The condition often progresses slowly, with symptoms worsening over the years. It is more common in older adults and can be influenced by factors such as genetics and previous joint injuries. The pain associated with digital osteoarthritis can sometimes have a neuropathic component, meaning it may involve nerve-related pain.

Trial ID:

2024-511159-16-00

Protocol code:

PHRC IR 2022 MATHIEU

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Capsaicin for Finger Pain in Digital Osteoarthritis Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?