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Greater Occipital Nerve Block for Migraine With Medication Overuse Headache (GONB_MOH)

11. maj 2026 opdateret af: Pannathat Soontrapa, Mahidol University
Migraine is among the leading causes of disability worldwide. Inappropriate use of acute medications in the setting of primary headache, particularly migraine can result in a debilitating condition known as medication overuse headache (MOH). Treatment of MOH is challenging and the primary therapeutic approach is reducing painkillers which helps decrease the number of headache days. As a part of the detoxification process to discontinue acute medications, bridging therapy is often needed to reduce withdrawal headache. Currently, there are data supporting the use of greater occipital nerve block as a preventive treatment in chronic migraine, but no placebo-controlled trial has evaluated the efficacy of greater occipital nerve block in MOH. Therefore, this research aims to demonstrate the efficacy of greater occipital nerve block in detoxification of migraine patients with MOH. Patients will be recruited from Headache Clinic at 3 centers in Thailand from February 2026 to January 2028. After recruitment, patients will be randomized into 2 groups at a 1:1 ratio using a block of four, namely group A and B. A 5-mL syringe of 2 mL of lidocaine 2% and 2 mL of methylprednisolone 40 mg/mL (80 mg) will be prepared for each patient in group while a 5-mL syringe of 4 mL normal saline will be prepared for each patient in group B. Monthly headache days, duration, severity, acute medication type and number of usage days and relative headache status according to a 5-point Likert scale will be investigated at the 2 weeks, 1st, 2nd and 3rd month, MIDAS at the end of 3rd month.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

130

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University
        • Kontakt:
        • Ledende efterforsker:
          • Pannathat Soontrapa, M.D.
    • Changwat Songkhla
      • Hat Yai, Changwat Songkhla, Thailand, 90110
        • Faculty of Medicine, Prince of Songkla University
        • Kontakt:
        • Underforsker:
          • Prut Koonalintip, M.D.
    • Chiang Mai
      • Chiang Mai, Chiang Mai, Thailand, 50200
        • Faculty of Medicine, Chiang Mai University
        • Kontakt:
        • Underforsker:
          • Surat Tanprawate, M.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Patients who have a diagnosis of migraine with medication overuse headache according to ICHD-3 criteria confirmed by a neurologist
  • Female patients will be screened for pregnancy planning and married female patients must undergo a urine pregnancy test

Exclusion Criteria:

  • Patients who have other types of headache disorders other than migraine
  • Patients who have a previous history of allergy to corticosteroid or lidocaine
  • Patients who had previous skull surgery
  • Pregnant women
  • Patients with a history of uncontrolled depression, or psychosis
  • Patients who get or plan to get CGRP-targeted therapies or botulinum toxin injection
  • Patients with an increased risk of bleeding or underlying bleeding disorders

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Active treatment (GONB)
Participants receive Greater Occipital Nerve Block (GONB) with 2% Lidocaine + methylprednisolone 80 mg
Medicin: Lidocaine 2% and Methylprednisolone 80 mg
A 4-mL injection containing 2 mL of lidocaine 2% and 2 mL of methylprednisolone 40 mg/mL (80 mg). The injection is administered at the medial third of the distance between the external occipital protuberance and the mastoid process.
Placebo komparator: Placebo group
Participants receive occipital injection with Normal Saline (0.9% NaCl).
Andet: Placebo
A 4-mL injection of 0.9% Normal Saline administered at the medial third of the distance between the external occipital protuberance and the mastoid process.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of patients with Medication Overuse Headache (MOH)
Tidsramme: At the end of month 1 and month 3 after detoxification.
The percentage of participants diagnosed with Medication Overuse Headache (MOH) according to ICHD criteria.
At the end of month 1 and month 3 after detoxification.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of patients achieving 50% improvement in migraine
Tidsramme: At the end of month 3.
The percentage of patients with at least a 50% reduction in monthly headache days compared to baseline (month -1).
At the end of month 3.
Change in monthly headache days
Tidsramme: Baseline (month -1) and month 3.
The mean change in the number of headache days per month from baseline to month 3.
Baseline (month -1) and month 3.
Change in mean headache severity
Tidsramme: Baseline (month -1) and month 3.
The change in mean headache severity scores measured by the Visual Analog Scale (VAS). 0 being no pain and 10 being the worst pain
Baseline (month -1) and month 3.
Change in Migraine Disability Assessment (MIDAS) Score
Tidsramme: Baseline (month -1) and month 3.
Evaluation of the change in disability caused by migraines using the MIDAS questionnaire. MIDAS score ranges from 0 to 270 with the higher score, the worse disability.
Baseline (month -1) and month 3.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mahidol University

Samarbejdspartnere

Prince of Songkla University
The Royal College of Physicians of Thailand
Chiang Mai University, Thailand

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. november 2028

Studieafslutning (Anslået)

1. november 2028

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Si321/2026

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Lidocaine 2% and Methylprednisolone 80 mg

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