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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topiramate | Active Comparator | 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 +Supratrochlear Nerve Block | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topamax | Drug | An antiepileptic agent used for migraine prophylaxis. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale | Range Pain 0-10, 0: No pain, 10: Worst Pain | Post treatment (4 weeks later) |
| Attack Frequencies | Number of headaches patients suffer in a month. | Post treatment (4 weeks later) |
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Inclusion Criteria:
J-w/o chronic systemic diseases including hypertension, cardiac insufficiency, diabetes, pulmonary disease, kidney disease, liver disease, and peripheral arterial disease.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mustafa Ceylan | Erzurum | 25000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12874392 | Background | 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. | |
| 15209690 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Topamax: An antiepileptic agent used for migraine prophylaxis. |
| FG001 | 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. Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Topamax: An antiepileptic agent used for migraine prophylaxis. |
| BG001 | Greater Occipital +Supratrochlear Nerve Block |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scale | Range Pain 0-10, 0: No pain, 10: Worst Pain | Posted | Mean | Standard Deviation | units on a scale | Post treatment (4 weeks later) |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Topamax: An antiepileptic agent used for migraine prophylaxis. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Non-systematic Assessment | Dizziness that affect concentration |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mustafa Ceylan | Ataturk University | +905062773216 | drmuson16@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2019 | Dec 23, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D006261 | Headache |
| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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| Greater Occipital Nerve Block + Supratrochlear Nerve Block |
| Procedure |
An injection to paralyze the occipital and supratrochlear nerves. |
|
| 17300356 | Background | 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. |
| 19912347 | Background | 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. |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Primary | Attack Frequencies | Number of headaches patients suffer in a month. | Posted | Mean | Standard Deviation | headaches per month | Post treatment (4 weeks later) |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 2 |
| 45 |
| EG001 | 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. Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves. | 0 | 45 | 0 | 45 | 0 | 45 |
|
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Carbohydrates |
| D007661 | Ketoses |