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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

18 criteria

  • 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 trial?

3 criteria

  • 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.
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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.

What is already known about the treatment

Botox – Botox is administered through injection, specifically targeting the area around nerves, known as perineural injection. It is currently being studied for its potential to relieve chronic cutaneous neuropathic pain, a condition characterized by nerve damage leading to persistent pain. The main therapeutic indication being explored is neuropathy, particularly in cases where traditional pain management strategies are ineffective. At the molecular level, Botox works by blocking the release of certain neurotransmitters that are involved in pain signaling, thereby reducing pain perception. It is classified pharmacologically as a neurotoxin, commonly used for both medical and cosmetic purposes.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507259-31-00Estimated enrolment50 patientsSponsorRegion Midtjylland

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