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Search / Trial NCT06036043

Botulinum Toxin for Chronic Neuropathic Pain

Launched by REGION ZEALAND · Sep 11, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Botulinum Toxin Chronic Pain Neuropathic Pain

ClinConnect Summary

This clinical trial is studying the use of Botulinum Toxin (often known as Botox) to help relieve chronic neuropathic pain, which is a type of pain caused by nerve damage. Since earlier studies have shown that this treatment may help, researchers want to learn more about how effective it is, how it should be given, and how long the pain relief lasts. The trial is currently looking for participants aged 65 to 74 who have been diagnosed with neuropathic pain, which can cause symptoms like burning or stabbing sensations. To qualify, participants must have their pain confirmed through testing and should have identifiable areas of pain.

Those who join the study will receive the Botulinum Toxin treatment and will be monitored for its effects on their pain and any side effects. It's important to note that not everyone can participate; for instance, individuals with certain other pain conditions, allergies to the toxin, or severe psychiatric disorders cannot join. If you're interested and meet the criteria, this trial could provide an opportunity to explore a new approach to managing chronic pain.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Condition of neuropathic pain verified by paraclinical examination or supported by underlying diseases (e.g., diabetes or herpes zoster).
  • The condition is characterized by allodynia, hyperalgesia, and/or neuralgiform symptoms such as burning and stabbing pain.
  • The affected area can be identified through objective examination with detection of disturbances in touch using cotton swabs, pin-prick, and/or vibration
  • Exclusion Criteria:
  • Mixed etiology of pain not solely attributable to neuropathy (e.g., fibromyalgia and neuropathy or nociceptive pain and neuropathy).
  • Contraindication to BoNT treatment (allergy to the toxin).
  • Pregnancy.
  • Diseases where BoNT treatment is contraindicated, such as motor neuron diseases and muscular dystrophy.
  • Severe psychiatric disorder.

About Region Zealand

Region Zealand is a leading healthcare organization dedicated to advancing medical research and improving patient outcomes in Denmark's Zealand region. As a clinical trial sponsor, Region Zealand collaborates with healthcare professionals, researchers, and academic institutions to facilitate innovative studies that address critical health challenges. With a focus on transparency, ethical standards, and patient safety, Region Zealand aims to enhance clinical practices and contribute to the global medical community through rigorous research, development of new therapies, and the implementation of evidence-based healthcare solutions.

Locations

Køge, , Denmark

Patients applied

0 patients applied

Trial Officials

Thomas Peter Enggaard, MD, PHD

Study Director

Rigshospitalet, Denmark

Ole Mathiesen, MD, PHD

Study Director

University Hospital of Region Zealand

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported