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Completed

NCT Number: NCT07497646

Repeated Bilateral Greater Occipital Nerve Blockade in Chronic Migraine and Chronic Tension-Type Headache

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.

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Key information

Conditions

Chronic Migraine Headache Brain Diseases Central Nervous System Diseases Chronic Tension-Type Headache Headache Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultan Abdulhamid Han Research and Training Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

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.

Other names: Bupivacaine hydrochloride, 0.5% bupivacaine

Normal Saline (0.9% NaCl)

Drug

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.

Other names: Sodium chloride, Normal saline, 0.9% NaCl

Greater occipital nerve blockade

Procedure

Bilateral greater occipital nerve blockade performed using the standard injection technique described in the protocol.

Primary outcomes

  1. Change from baseline in monthly number of headache days assessed using patient-reported daily headache diary

    Time frame: 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 outcomes

  1. Change from baseline in pain intensity measured using the Visual Analog Scale (VAS) for pain

    Time frame: 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.

  2. Change from baseline in total monthly headache duration (hours) assessed using patient-reported daily headache diary

    Time frame: 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.

  3. Change from baseline in headache-related disability measured using the Migraine Disability Assessment (MIDAS) questionnaire

    Time frame: 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.

  4. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Collaborators

  • Turkish Neurological Society

Registry information

Official study title

Repeated Bilateral Greater Occipital Nerve Blockade in Chronic Migraine and Chronic Tension-Type Headache: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial

Acronym: GONBLOCK-RCT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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