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Study on Capsaicin Patch for Treating Chronic Neuropathic Pain in Children Aged 12-17

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What is this study about?

This clinical trial is focused on studying the effectiveness of a treatment for chronic postsurgical or post-traumatic neuropathic pain in children aged 12 to 17 years. Neuropathic pain is a type of pain that occurs when there is damage to the nerves, often following surgery or an injury. The treatment being tested is a patch called Qutenza, which contains capsaicin, a substance known for its pain-relieving properties. The study will compare the effects of the capsaicin patch to a placebo to determine its effectiveness in reducing pain symptoms.

Participants in the study will receive either the capsaicin patch or a placebo patch. The patches are applied to the skin, and the study will monitor changes in pain levels over a period of four months. The main goal is to see if the capsaicin patch can improve the symptoms of neuropathic pain, as measured by a specific questionnaire called the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire helps to assess the severity and impact of the pain on daily life.

Throughout the study, participants will be closely monitored for any side effects or changes in their health. This includes regular check-ups and phone calls to ensure their well-being. The study aims to provide valuable information on whether the capsaicin patch can be an effective treatment option for young people suffering from chronic neuropathic pain after surgery or injury.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to evaluate the current level of neuropathic pain. This involves completing the Neuropathic Pain Symptom Inventory (NPSI) questionnaire, which measures pain symptoms on a scale from 0 to 100, where a higher score indicates worse pain.

A physical examination will be performed, including a dermal assessment to check the condition of the skin.

2 first application of treatment

The first application of the treatment involves using a capsaicin 8% cutaneous patch or a placebo. The patch is applied to the skin in the area where pain is experienced.

The duration of the patch application will be monitored, and any adverse events will be recorded during this time.

3 follow-up assessments

After the initial application, follow-up assessments will be conducted over a period of 4 months. These assessments include monitoring vital signs such as heart rate and blood pressure.

Additional phone calls will be made to check for any adverse events and to ensure the patient’s well-being.

4 final evaluation

At the end of the 4-month period, a final evaluation will be conducted. This includes completing the NPSI questionnaire again to assess any changes in pain symptoms.

The Functional Disability Inventory (FDI) questionnaire will also be completed to evaluate any changes in daily functioning, with scores ranging from 0 to 60, where a higher score indicates greater disability.

Who Can Join the Study?

  • Children aged 12 to 17 years.
  • Can be either male or female.
  • Have persistent neuropathic pain for more than 32 months after surgery or an injury, even after following treatment recommendations. Neuropathic pain is a type of pain caused by nerve damage.
  • The pain should have a DN4 score of 3 out of 7 or 4 out of 10 or higher. The DN4 score is a tool used to measure the level of neuropathic pain.
  • The pain must be located in an area explained by the surgery or injury.
  • All treatment, monitoring, and follow-up must be done at a designated study center.

Who Cannot Join the Study?

  • Patients who are not between the ages of 12 and 17 cannot participate.
  • Patients who do not have chronic post-surgical or post-traumatic neuropathic pain cannot participate. This type of pain is a long-lasting pain that occurs after surgery or an injury.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may 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
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Institut Gustave Roussy Villejuif France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Hospices Civils De Lyon Lyon France
Ampzifincs Pctojyvm Hxyhilsr Dl Mpouvnaia Marseille France
Cnysof Hgyzdqxtsdv Rlvmzjux Uwfvpbjlqivgz Dr Tsqks Tours France
Cdiudn Hrezaitdbyd Rhzcroys Dbsmxoopdedlkr Angers France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.07.2023

Trial locations

Investigated drugs:

Capsaicin 8% cutaneous patch is a treatment used in this clinical trial to help reduce chronic pain that occurs after surgery or an injury. The patch contains capsaicin, which is a natural compound found in chili peppers. When applied to the skin, it works by reducing the amount of a substance in the body that sends pain signals to the brain. This can help lessen the feeling of pain in the affected area. In this study, the patch is being tested to see how well it works in children aged 12 to 17 who have long-lasting pain after surgery or an injury.

Chronic postsurgical or post-traumatic neuropathic pain – This condition arises when nerves are damaged during surgery or trauma, leading to persistent pain. The pain is often described as burning, shooting, or stabbing and can be accompanied by sensations of tingling or numbness. It typically occurs in the area of the original injury or surgical site. Over time, the pain may become more widespread or intense. The condition can lead to increased sensitivity to touch or temperature changes. It is a chronic condition, meaning it persists for a long time and can significantly impact daily activities and quality of life.

Trial ID:
2022-500265-27-00
Protocol code:
29BRC21.0184
NCT ID:
NCT05997979
Trial Phase:
Therapeutic confirmatory (Phase III)

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