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

NCT07497646 | Completed

• 1 other identifier: GON-RCT-2022
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Migraine Headache; Chronic Tension-type Headache

Keywords

Chronic Tension-Type Headache; Greater Occipital Nerve Block; Chronic Headache; Bupivacaine; Migraine Treatment; Peripheral Nerve Block

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (4)

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

  Baseline and Month 3

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

  Baseline and Month 3

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

  Baseline and Month 3

• Incidence of treatment-emergent adverse events (TEAEs)

  Up to Month 3

Study Arms (2)

Bupivacaine GON Blockade

EXPERIMENTAL

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; Procedure: Greater occipital nerve blockade

Placebo GON Blockade

PLACEBO COMPARATOR

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.

Drug: Normal Saline (0.9% NaCl); Procedure: Greater occipital nerve blockade

Interventions

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.

Also known as: Bupivacaine hydrochloride, 0.5% bupivacaine

Bupivacaine GON Blockade

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.

Also known as: Sodium chloride, Normal saline, 0.9% NaCl

Placebo GON Blockade

Greater occipital nerve blockade PROCEDURE

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

Bupivacaine GON Blockade; Placebo GON Blockade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• Turkish Neurological Society: collaborator

Study Sites (1)

Sultan Abdulhamid Han Research and Training Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Headache Disorders

Interventions

Bupivacaine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 27, 2026
• Study Start: January 1, 2025
• Primary Completion: July 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)