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Study on the Effect of Botulinum Toxin Type A and Sodium Chloride for Patients with Chronic Neuropathic Pain

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for chronic neuropathic pain, which is a type of long-lasting pain caused by nerve damage. The treatment being tested is an injection of Botox, a well-known medication that is often used for various medical and cosmetic purposes. In this study, Botox is being used to see if it can help relieve pain when injected near the affected nerves. The trial will also involve a comparison with a placebo to evaluate the effectiveness of Botox in reducing pain.

The main goal of the study is to investigate whether Botox can provide pain relief for individuals suffering from chronic neuropathic pain. Participants in the study will receive either the Botox injection or a placebo. The study will monitor the participants over a period of time to assess changes in their pain levels and overall satisfaction with the treatment. The study will also look at how quickly the pain relief begins and how long it lasts.

Throughout the study, participants will be asked to report on their pain levels, any changes in their daily activities, and their overall satisfaction with the treatment. The study aims to provide valuable information on the potential benefits of using Botox for managing chronic neuropathic pain, which could lead to improved treatment options for those affected by this condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, pain characteristics, and previous treatments.

Informed consent is required, and the ability to evaluate pain subjectively is necessary.

2 initial assessment

An initial assessment is conducted to evaluate the pain level using a numeric rating scale (NRS).

The assessment includes a review of the patient’s medical history and current condition.

3 treatment administration

The treatment involves the injection of botulinum toxin type a (BOTOX) into the affected area.

The injection is performed perineurally, meaning it is administered around the nerve.

The dosage is 50 Allergan units, and it is given as a solution for injection.

4 follow-up and monitoring

Follow-up occurs at 4 weeks after the injection to assess the pain-relieving effect.

The primary endpoint is the number of responders who report mild, moderate, or good pain relief in the last 48 hours.

Secondary endpoints include changes in pain scores, sleep quality, activity level, and overall satisfaction with the treatment.

5 evaluation of results

The effectiveness of the treatment is evaluated based on the change in pain scores and other secondary endpoints.

The duration of the pain-relieving effect and any adverse events are also recorded.

6 completion of the trial

The trial is estimated to end by October 1, 2024.

Participants’ feedback on the treatment and their willingness to recommend or receive it again in the future are collected.

Who Can Join the Study?

  • Must be 18 years or older.
  • Must have painful areas where certain sensations are different compared to the opposite side of the body. These sensations include:
    • Reduced feeling or no feeling for touch.
    • Reduced feeling or no feeling for moderate cold.
    • Reduced feeling or no feeling for moderate heat.
    • Reduced feeling or no feeling for pinprick.
    • Pain from touch that normally wouldn’t hurt.
    • Pain from moderate cold that normally wouldn’t hurt.
    • Pain from moderate heat that normally wouldn’t hurt.
    • Increased pain from pinprick.
  • Must have had a nerve block procedure at the Nerve Injury Clinic within the last 28 days, which reduced pain to a score of 3 or below on a pain scale.
  • Must have an ASA score of I-III, which is a way to classify physical health.
  • Must be a suitable candidate for botox injection as assessed by the study doctor.
  • Must provide informed consent, meaning you agree to participate after understanding the study.
  • Must be able to evaluate your own pain.
  • Must be able to read and understand Danish and sign the consent form.
  • Must have a pain score of 5 or higher in the main pain area for at least 6 months.
  • Must have tried first-line treatments for neuropathic pain, and these treatments are either stable or stopped.
  • The location of the painful skin area must make sense in relation to the suspected nerve damage, as assessed by the study doctor.

Who Cannot Join the Study?

  • Patients who are not experiencing chronic cutaneous neuropathic pain. This is a type of long-lasting pain that affects the skin due to nerve damage.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means groups that might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Avqcwo Ulzhcdrtri Hmjomhzn Aarhus Denmark

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

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
01.09.2023

Trial locations

Investigated drugs:

Botox is being studied for its potential to relieve chronic cutaneous neuropathic pain. In this trial, Botox is injected around nerves (perineural injection) to see if it can reduce pain in patients who suffer from this type of chronic pain. The goal is to determine if Botox can be an effective treatment option for managing pain that is related to nerve damage in the skin.

Neuropathy – Neuropathy is a condition that affects the nerves, leading to symptoms such as pain, tingling, numbness, or weakness, primarily in the hands and feet. It can result from various causes, including diabetes, infections, or injuries. The progression of neuropathy can vary depending on the underlying cause, but it often starts with mild symptoms that gradually worsen over time. As the condition advances, individuals may experience increased difficulty with coordination and balance. In some cases, neuropathy can lead to muscle weakness and loss of reflexes. The severity and progression of symptoms can differ significantly from person to person.

Trial ID:
2023-507259-31-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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