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

• Sponsor: Ataturk University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03767062
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Actual Duration (Days): 30
• Patients Per Site Per Month: 91.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Medication Overuse Headache; Chronic Migraine, Headache	Drug: Topamax; Procedure: Greater Occipital Nerve Block + Supratrochlear Nerve Block	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of Effects of Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches: A Randomised Parallel Group Study
• Actual Study Start Date: Mar 1, 2019
• Actual Primary Completion Date: Mar 31, 2019
• Actual Study Completion Date: Mar 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Topamax; An antiepileptic agent used for migraine prophylaxis.
Active Comparator: 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.	Procedure: Greater Occipital Nerve Block + Supratrochlear Nerve Block; An injection to paralyze the occipital and supratrochlear nerves.

Outcome Measures

Primary Outcome Measures

1. Visual Analog Scale [Post treatment (4 weeks later)]

   Range Pain 0-10, 0: No pain, 10: Worst Pain

2. Attack Frequencies [Post treatment (4 weeks later)]

   Number of headaches patients suffer in a month.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mustafa Ceylan	Erzurum		Turkey	25000

Sponsors and Collaborators

• Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 7, 2019

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Mustafa Ceylan, Principal İnvastigator, Ataturk University
• ClinicalTrials.gov Identifier: NCT03767062
• Other Study ID Numbers: 2018/22-3
• First Posted: Dec 6, 2018
• Last Update Posted: Jan 22, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mustafa Ceylan, Principal İnvastigator, Ataturk University: Medication overuse headache; Greater occipital nerve block; supratrochlear nerve block; topiramate.
• Additional relevant MeSH terms: Headache Disorders, Secondary; Headache; Topiramate

Study Results

Participant Flow

Arm/Group Title	Topiramate	Greater Occipital +Supratrochlear Nerve Block
Arm/Group 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. Topamax: An antiepileptic agent used for migraine prophylaxis.	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. Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves.
Period Title: Overall Study
STARTED	45	45
COMPLETED	37	41
NOT COMPLETED	8	4

Baseline Characteristics

Arm/Group Title	Topiramate	Greater Occipital +Supratrochlear Nerve Block	Total
Arm/Group 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. Topamax: An antiepileptic agent used for migraine prophylaxis.	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. Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves.	Total of all reporting groups
Overall Participants	45	45	90
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	45 100%	45 100%	90 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.7 (7.1)	32.9 (7.2)	32.8 (7.1)
Sex: Female, Male (Count of Participants)
Female	45 100%	45 100%	90 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	45 100%	45 100%	90 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Turkey	45 100%	45 100%	90 100%

Outcome Measures

1. Primary Outcome

Title	Visual Analog Scale
Description	Range Pain 0-10, 0: No pain, 10: Worst Pain
Time Frame	Post treatment (4 weeks later)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topiramate	Greater Occipital +Supratrochlear Nerve Block
Arm/Group 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. Topamax: An antiepileptic agent used for migraine prophylaxis.	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. Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves.
Measure Participants	37	41
Pretreatment (Baseline)	8.3 (0.8)	8.4 (0.7)
Post treatment (4 weeks later)	5.3 (1.2)	5.3 (1.1)

2. Primary Outcome

Title	Attack Frequencies
Description	Number of headaches patients suffer in a month.
Time Frame	Post treatment (4 weeks later)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topiramate	Greater Occipital +Supratrochlear Nerve Block
Arm/Group 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. Topamax: An antiepileptic agent used for migraine prophylaxis.	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. Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves.
Measure Participants	37	41
Pretreatment (Baseline)	21.2 (3.1)	20.9 (2.7)
Post treatment (4 weeks later)	4.7 (2.8)	5.9 (2.9)

Adverse Events

Time Frame	4 weeks
Arm/Group Title	Topiramate		Greater Occipital +Supratrochlear Nerve Block
Arm/Group 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. Topamax: An antiepileptic agent used for migraine prophylaxis.		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. Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves.
All Cause Mortality
	Topiramate		Greater Occipital +Supratrochlear Nerve Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)
Serious Adverse Events
	Topiramate		Greater Occipital +Supratrochlear Nerve Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	Topiramate		Greater Occipital +Supratrochlear Nerve Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/45 (4.4%)		0/45 (0%)
Nervous system disorders
Dizziness	2/45 (4.4%)	2	0/45 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.