Comparing nerve block injections to Botox for chronic migraine relief
A Randomized Controlled Trial Comparing the Efficacy of Supratrochlear and Greater Occipital Nerve Blocks to Botulinum Toxin A in the Management of Chronic Migraine
This study tests whether nerve block injections or Botox can help adults with chronic migraines feel better and have fewer migraine days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Zagazig University Government |
| Locations | 1 site (Zagazig, Sharqia Province) |
| Trial ID | NCT06684249 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of nerve block injections versus Botulinum toxin A (Botox) in managing chronic migraines in adults. Participants will be randomly assigned to receive either nerve block injections or Botox every 12 weeks for a total of 6 months. The study will assess the reduction in the number of migraine days per month, changes in migraine severity, and patient satisfaction. Participants will maintain a headache diary to track their symptoms and any side effects throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of chronic migraine, experiencing headaches on 15 or more days per month.
Not a fit: Patients with a history of allergy to local anesthetics or Botox, or those who have had previous treatments within the last 6 months, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an alternative treatment option for chronic migraine sufferers, potentially improving their quality of life.
How similar studies have performed: While nerve blocks and Botox are both established treatments for chronic migraines, this specific comparative approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 to 65 years. * Diagnosis of chronic migraine, defined as having headaches on 15 or more days per month for more than three months, with at least 8 of those days meeting criteria for migraine. * Ability to provide informed consent and comply with study requirements. * No changes in prophylactic migraine medications in the last 3 months. Exclusion Criteria: * History of allergy or hypersensitivity to local anesthetics or Botulinum toxin. * Previous nerve block or Botox treatment within the last 6 months. * Significant comorbid psychiatric or neurological disorders that could interfere with study participation or evaluation. * Pregnancy or breastfeeding. * Contraindications to either treatment as per product labels.
Where this trial is running
Zagazig, Sharqia Province
- Zagazig University, Faculty of Medicine — Zagazig, Sharqia Province, Egypt (Recruiting)
Study contacts
- Principal investigator: Ahmed Bessar, MD, PhD — Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
- Study coordinator: Ahmed A Bessar, MD, PhD
- Email: Ahmedawadbessar@gmail.com
- Phone: +201000089595
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.