Using Botulinum Toxin to Treat Chronic Neuropathic Pain
Botulinum Toxin for Chronic Neuropathic Pain - an Interventional Open Label Study at the Interdisciplinary Pain Center, Zealand University Hospital
This study is testing if Botulinum Toxin can help people with chronic nerve pain feel better and how long the relief lasts.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Zealand Academic / other |
| Locations | 1 site (Køge) |
| Trial ID | NCT06036043 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy and safety of Botulinum Toxin (BoNT) in treating chronic neuropathic pain, which includes conditions like diabetic neuropathy and post-herpetic neuropathy. The study will follow a cohort of patients over one year, monitoring their response to three treatments and assessing the duration of pain relief and any adverse reactions. By systematically documenting outcomes, the study seeks to clarify the effectiveness of BoNT and address unanswered questions regarding its use in chronic pain management.
Who should consider this trial
Good fit: Ideal candidates are individuals with verified neuropathic pain characterized by symptoms such as allodynia and hyperalgesia, and who have not found relief from first and second-line treatments.
Not a fit: Patients with mixed pain etiologies, contraindications to Botulinum Toxin, or severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief for patients suffering from chronic neuropathic pain who have not responded to standard therapies.
How similar studies have performed: Previous studies have shown promising results for Botulinum Toxin in treating neuropathic pain, although this study aims to provide more comprehensive data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Køge
- University Hospital of regions Zealand — Køge, Denmark (Recruiting)
Study contacts
- Study coordinator: Rune Frederiksen, MD
- Email: Rune@acamedia.org
- Phone: 26802789
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.