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Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches

Primary Purpose

Medication Overuse Headache, Chronic Migraine, Headache

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Topamax
Greater Occipital Nerve Block + Supratrochlear Nerve Block
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medication Overuse Headache focused on measuring Medication overuse headache; Greater occipital nerve block; supratrochlear nerve block; topiramate.

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Chronic migraine diagnosis according to International Classification of Headache-2 Disorders (ICHD)
  2. w/o pregnancy or breastfeeding.
  3. w/o acute or chronic psychiatric disorders.
  4. w/o nephrolithiasis.
  5. w/o medication of anticoagulant and antiaggregant.
  6. w/o allergy to topiramate or bupivacaine.
  7. w/o prophylaxis within the last three months with any of; propranolol, nebivolol, topiramate, valproate, venlafaxine, duloxetine, amitriptyline, flunarizine.
  8. w/o previous history of peripheral nerve block, botulinum toxin or acupuncture.
  9. 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:

  1. Lost to follow up within the pretreatment period during the detoxification therapy after the detoxification therapy
  2. could not tolerate the peripheral nerve block or topiramate

Sites / Locations

  • Mustafa Ceylan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Topiramate

Greater Occipital +Supratrochlear Nerve Block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Visual Analog Scale
Range Pain 0-10, 0: No pain, 10: Worst Pain
Attack Frequencies
Number of headaches patients suffer in a month.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2018
Last Updated
January 17, 2020
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT03767062
Brief Title
Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches
Official Title
Comparison of Effects of Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches: A Randomised Parallel Group Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Overuse Headache, Chronic Migraine, Headache
Keywords
Medication overuse headache; Greater occipital nerve block; supratrochlear nerve block; topiramate.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topiramate
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Greater Occipital +Supratrochlear Nerve Block
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Topamax
Intervention Description
An antiepileptic agent used for migraine prophylaxis.
Intervention Type
Procedure
Intervention Name(s)
Greater Occipital Nerve Block + Supratrochlear Nerve Block
Intervention Description
An injection to paralyze the occipital and supratrochlear nerves.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
Range Pain 0-10, 0: No pain, 10: Worst Pain
Time Frame
Post treatment (4 weeks later)
Title
Attack Frequencies
Description
Number of headaches patients suffer in a month.
Time Frame
Post treatment (4 weeks later)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Mustafa Ceylan
City
Erzurum
ZIP/Postal Code
25000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12874392
Citation
Zwart JA, Dyb G, Hagen K, Svebak S, Holmen J. Analgesic use: a predictor of chronic pain and medication overuse headache: the Head-HUNT Study. Neurology. 2003 Jul 22;61(2):160-4. doi: 10.1212/01.wnl.0000069924.69078.8d.
Results Reference
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PubMed Identifier
15209690
Citation
Grazzi L, Andrasik F, D'Amico D, Usai S, Kass S, Bussone G. Disability in chronic migraine patients with medication overuse: treatment effects at 1-year follow-up. Headache. 2004 Jul-Aug;44(7):678-83. doi: 10.1111/j.1526-4610.2004.04127.x.
Results Reference
background
PubMed Identifier
17300356
Citation
Silberstein SD, Lipton RB, Dodick DW, Freitag FG, Ramadan N, Mathew N, Brandes JL, Bigal M, Saper J, Ascher S, Jordan DM, Greenberg SJ, Hulihan J; Topiramate Chronic Migraine Study Group. Efficacy and safety of topiramate for the treatment of chronic migraine: a randomized, double-blind, placebo-controlled trial. Headache. 2007 Feb;47(2):170-80. doi: 10.1111/j.1526-4610.2006.00684.x.
Results Reference
background
PubMed Identifier
19912347
Citation
Tobin JA, Flitman SS. Occipital nerve blocks: effect of symptomatic medication: overuse and headache type on failure rate. Headache. 2009 Nov-Dec;49(10):1479-85. doi: 10.1111/j.1526-4610.2009.01549.x.
Results Reference
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Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches

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