Comparison of Effects of Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches: A Randomised Parallel Group Study
Overview
- Phase
- Not Applicable
- Intervention
- Topamax
- Conditions
- Medication Overuse Headache
- Sponsor
- Ataturk University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Mustafa Ceylan
Principal İnvastigator
Ataturk University
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
Arms & Interventions
Topiramate
Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.
Intervention: Topamax
Greater Occipital +Supratrochlear Nerve Block
Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼" (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.
Intervention: Greater Occipital Nerve Block + Supratrochlear Nerve Block
Outcomes
Primary Outcomes
Visual Analog Scale
Time Frame: Post treatment (4 weeks later)
Range Pain 0-10, 0: No pain, 10: Worst Pain
Attack Frequencies
Time Frame: Post treatment (4 weeks later)
Number of headaches patients suffer in a month.