N/A
N=90
Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches
Medication Overuse Headache · Chronic Migraine, Headache
Bottom Line
View on ClinicalTrials.gov: NCT03767062 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Visual Analog Scale — 8.3; 8.4; 5.3; 5.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Topamax (Drug); Greater Occipital Nerve Block + Supratrochlear Nerve Block (Procedure)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Ataturk University
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale |
8.3; 8.4; 5.3; 5.3 | — |
| PRIMARY Attack Frequencies |
21.2; 20.9; 4.7; 5.9 | — |
Summary
Purpose: In this study, the investigators compared the effectiveness of peripheral nerve block (greater occipital nerve block with supratrochlear nerve block) versus topiramate as detoxification therapies in chronic migraine patients with medication overuse headache.
Methods: At least ninety chronic migraine patients with medication overuse headache are aimed to include in this study. Patients will be divided into the two groups. The first group will receive topiramate (n=45, estimated) and the second group will receive nerve block (n=45, estimated) as detoxification therapy. Patients' records regarding the visual analog scale (VAS) scores and headache frequencies are aimed to be collected before and after the therapy. Comparisons regarding VAS scores, headache frequencies, 50% responder rates and 75% responder rates will be performed in between topiramate and nerve block groups.
Eligibility Criteria
Inclusion Criteria
- Chronic migraine diagnosis according to International Classification of Headache-2 Disorders (ICHD)
- w/o pregnancy or breastfeeding.
- w/o acute or chronic psychiatric disorders.
- w/o nephrolithiasis.
- w/o medication of anticoagulant and antiaggregant.
- w/o allergy to topiramate or bupivacaine.
- w/o prophylaxis within the last three months with any of; propranolol, nebivolol, topiramate, valproate, venlafaxine, duloxetine, amitriptyline, flunarizine.
- w/o previous history of peripheral nerve block, botulinum toxin or acupuncture.
- w/o history of multiple sclerosis, movement disorders, epilepsy, stroke, and tumor.
J-w/o chronic systemic diseases including hypertension, cardiac insufficiency, diabetes, pulmonary disease, kidney disease, liver disease, and peripheral arterial disease.
Exclusion Criteria
- Lost to follow up within the pretreatment period during the detoxification therapy after the detoxification therapy
- could not tolerate the peripheral nerve block or topiramate
Data sourced from ClinicalTrials.gov (NCT03767062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.