Chronic Migraine, Headache, Medication Overuse Headache
Conditions
Keywords
Medication overuse headache; Greater occipital nerve block; supratrochlear nerve block; topiramate.
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.
Interventions
DRUGTopamax
An antiepileptic agent used for migraine prophylaxis.
PROCEDUREGreater Occipital Nerve Block + Supratrochlear Nerve Block
An injection to paralyze the occipital and supratrochlear nerves.
Sponsors
Ataturk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | Post treatment (4 weeks later) | Range Pain 0-10, 0: No pain, 10: Worst Pain |
| Attack Frequencies | Post treatment (4 weeks later) | Number of headaches patients suffer in a month. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| 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. | 45 |
| Total | 90 |
Baseline characteristics
| Characteristic | Total | Greater Occipital +Supratrochlear Nerve Block | Topiramate |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants | 45 Participants | 45 Participants |
| Age, Continuous | 32.8 years STANDARD_DEVIATION 7.1 | 32.9 years STANDARD_DEVIATION 7.2 | 32.7 years STANDARD_DEVIATION 7.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 90 Participants | 45 Participants | 45 Participants |
| Region of Enrollment Turkey | 90 Participants | 45 Participants | 45 Participants |
| Sex: Female, Male Female | 90 Participants | 45 Participants | 45 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 2 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Attack Frequencies
Number of headaches patients suffer in a month.
Time frame: Post treatment (4 weeks later)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Topiramate | Attack Frequencies | Pretreatment (Baseline) | 21.2 headaches per month | Standard Deviation 3.1 |
| Topiramate | Attack Frequencies | Post treatment (4 weeks later) | 4.7 headaches per month | Standard Deviation 2.8 |
| Greater Occipital +Supratrochlear Nerve Block | Attack Frequencies | Pretreatment (Baseline) | 20.9 headaches per month | Standard Deviation 2.7 |
| Greater Occipital +Supratrochlear Nerve Block | Attack Frequencies | Post treatment (4 weeks later) | 5.9 headaches per month | Standard Deviation 2.9 |
Primary
Visual Analog Scale
Range Pain 0-10, 0: No pain, 10: Worst Pain
Time frame: Post treatment (4 weeks later)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Topiramate | Visual Analog Scale | Post treatment (4 weeks later) | 5.3 units on a scale | Standard Deviation 1.2 |
| Topiramate | Visual Analog Scale | Pretreatment (Baseline) | 8.3 units on a scale | Standard Deviation 0.8 |
| Greater Occipital +Supratrochlear Nerve Block | Visual Analog Scale | Pretreatment (Baseline) | 8.4 units on a scale | Standard Deviation 0.7 |
| Greater Occipital +Supratrochlear Nerve Block | Visual Analog Scale | Post treatment (4 weeks later) | 5.3 units on a scale | Standard Deviation 1.1 |