Chronic Migraine Headache, Chronic Tension-type Headache
Conditions
Keywords
Chronic Tension-Type Headache, Greater Occipital Nerve Block, Chronic Headache, Bupivacaine, Migraine Treatment, Peripheral Nerve Block
Brief summary
This multicenter, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of repeated bilateral greater occipital nerve (GON) blockade in patients with chronic migraine and chronic tension-type headache. Greater occipital nerve blockade has been widely used as an interventional treatment for chronic headache disorders; however, evidence regarding its differential efficacy across chronic headache phenotypes remains limited. Participants diagnosed with chronic migraine or chronic tension-type headache according to the International Headache Society criteria were randomized to receive bilateral GON blockade with 0.5% bupivacaine or placebo (0.9% saline). Injections were administered weekly during the first month and monthly during the following two months, resulting in a total of six injections over a three-month treatment period. The primary outcome measure is the change in monthly headache frequency from baseline to Month 1. Secondary outcomes include changes in headache intensity, headache duration, disability scores, and other clinical headache parameters during follow-up.
Detailed description
This multicenter, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of repeated bilateral greater occipital nerve (GON) blockade in patients with chronic migraine and chronic tension-type headache. Greater occipital nerve blockade has been widely used as an interventional treatment for chronic headache disorders; however, evidence regarding its differential efficacy across chronic headache phenotypes remains limited. Participants diagnosed with chronic migraine or chronic tension-type headache according to the International Headache Society criteria were randomized to receive bilateral GON blockade with 0.5% bupivacaine or placebo (0.9% saline). Injections were administered weekly during the first month and monthly during the following two months, resulting in a total of six injections over a three-month treatment period. The primary outcome measure is the change in monthly headache frequency from baseline to Month 1. Secondary outcomes include changes in headache intensity, headache duration, disability scores, and other clinical headache parameters during follow-up.
Interventions
DRUGBupivacaine
0.5% bupivacaine administered as bilateral greater occipital nerve blockade. Injections were performed using 1.5 mL per side (total 3 mL per session). The procedure was repeated weekly during the first month and monthly during the following two months, resulting in a total of six injections.
DRUGNormal Saline (0.9% NaCl)
0.9% sodium chloride (normal saline) administered as placebo injections for bilateral greater occipital nerve blockade using the same injection volume (1.5 mL per side, total 3 mL) and schedule as the active treatment group.
PROCEDUREGreater occipital nerve blockade
Bilateral greater occipital nerve blockade performed using the standard injection technique described in the protocol.
Sponsors
Saglik Bilimleri Universitesi
Turkish Neurological Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study was conducted as a double-blind trial. Participants, treating physicians, investigators, and outcome assessors were blinded to treatment allocation. Active and placebo injections were prepared in identical syringes to maintain blinding.
Intervention model description
The study was conducted as a double-blind trial. Participants, treating physicians, investigators, and outcome assessors were blinded to treatment allocation. Active and placebo injections were prepared in identical syringes to maintain blinding.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults 18 years or older * Diagnosis of chronic migraine or chronic tension-type headache according to International Classification of Headache Disorders (ICHD-3) criteria * History of headache for at least 3 months prior to enrollment * Ability to provide written informed consent * Willingness to comply with study procedures and follow-up visits
Exclusion criteria
* Secondary headache disorders * Previous greater occipital nerve blockade within the last 3 months * Known allergy or contraindication to bupivacaine * Local infection at the injection site * Coagulation disorders or ongoing anticoagulant therapy that contraindicates injection procedures * Severe uncontrolled systemic disease * Pregnancy or breastfeeding * Participation in another clinical trial within the previous 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in monthly number of headache days assessed using patient-reported daily headache diary | Baseline and Month 1 | Change from baseline in the number of monthly headache days recorded using a patient-reported daily headache diary. A headache day is defined as any calendar day with headache lasting ≥4 hours or requiring acute medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pain intensity measured using the Visual Analog Scale (VAS) for pain | Baseline and Month 3 | Change from baseline in pain intensity measured using a 10-cm Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain. |
| Change from baseline in total monthly headache duration (hours) assessed using patient-reported daily headache diary | Baseline and Month 3 | Change from baseline in total monthly headache duration (hours), calculated from patient-reported daily headache diaries as the cumulative number of hours with headache per month. |
| Change from baseline in headache-related disability measured using the Migraine Disability Assessment (MIDAS) questionnaire | Baseline and Month 3 | Change from baseline in headache-related disability measured using the Migraine Disability Assessment (MIDAS) questionnaire. Scores range from 0 to 270, with higher scores indicating greater disability. |
| Incidence of treatment-emergent adverse events (TEAEs) | Up to Month 3 | The number and proportion of participants experiencing treatment-emergent adverse events (TEAEs), assessed through clinical evaluation and patient self-report. Adverse events were categorized by severity and relationship to the intervention. |
Countries
Turkey (Türkiye)
Outcome results
None listed