Repeated Bilateral Greater Occipital Nerve Blockade in Chronic Migraine and Chronic Tension-Type Headache (GONBLOCK-RCT)

March 24, 2026 updated by: NAZLI GAMZE BÜLBÜL, Saglik Bilimleri Universitesi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye)
        • Sultan Abdulhamid Han Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bupivacaine GON Blockade
Participants received bilateral greater occipital nerve blockade with 0.5% bupivacaine (1.5 mL per side). Injections were administered weekly during the first month and monthly during the following two months, resulting in six injections over a three-month period.
Drug: Bupivacaine
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
Procedure: Greater occipital nerve blockade
Bilateral greater occipital nerve blockade performed using the standard injection technique described in the protocol.
Placebo Comparator: Placebo GON Blockade
Participants received bilateral greater occipital nerve blockade with placebo injections consisting of 0.9% normal saline (1.5 mL per side), following the same injection schedule as the active treatment group.
Procedure: Greater occipital nerve blockade
Bilateral greater occipital nerve blockade performed using the standard injection technique described in the protocol.
Drug: Normal 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.
Other Names:
  • Sodium chloride
  • Normal saline
  • 0.9% NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Month 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Month 3
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.
Baseline and 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.
Baseline and Month 3
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.
Up to Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Collaborators

Turkish Neurological Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

July 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GON-RCT-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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