Onabotulinum toxin A treatment of cervicogenic headache: a randomised, double-blind, placebo-controlled crossover study.

Mattias Linde, Knut Hagen, Øyvind Salvesen, Gøril Bruvik Gravdahl, Grethe Helde, Lars Jacob Stovner
Author Information
  1. Mattias Linde: Norwegian University of Science and Technology, Norway. mattias.linde@ntnu.no

Abstract

AIMS: Preliminary reports regarding injections in the neck of onabotulinum toxin A have been positive in cervicogenic headache (CeH). The aim was to perform the first methodologically rigorous trial.
METHODS: A randomised, placebo-controlled, patient-, injector- and evaluator-blinded crossover study included 28 adult patients with a long-standing and treatment-resistant CeH. After a baseline period, injections of either onabotulinum toxin A or placebo were given in fixed sites in the neck muscles on the pain side. Second injections were given after ≥8 weeks. Patients were thereafter followed for another 8 weeks. A detailed headache calendar was filled in, and patients were followed with quality-of-life (QoL) questionnaires, algometry and neck mobility measurements.
RESULTS: There was no significant difference between verum and placebo in a mixed linear model analysis (p = 0.084) with regard to the primary end-point, reduction of days with moderate to severe headache. Six patients withdrew from the study before the second injections, but an intention-to-treat (ITT) analysis gave a similar result (p = 0.27). There were no significant differences favouring verum in any of the secondary efficacy measures. Side-effects of onabotulinum toxin A were minor and short-lasting.
CONCLUSION: Onabotulinum toxin A in neck muscles does not seem to be beneficial in CeH.

MeSH Term

Adult
Botulinum Toxins, Type A
Cross-Over Studies
Double-Blind Method
Female
Humans
Male
Neck Muscles
Neuromuscular Agents
Post-Traumatic Headache
Quality of Life
Range of Motion, Articular
Surveys and Questionnaires
Treatment Outcome

Chemicals

Neuromuscular Agents
Botulinum Toxins, Type A

Word Cloud

Created with Highcharts 10.0.0toxininjectionsneckonabotulinumheadacheCeHstudypatientscervicogenicrandomisedplacebo-controlledcrossoverplacebogivenmusclesweeksfollowedsignificantverumanalysisp = 0OnabotulinumAIMS:PreliminaryreportsregardingpositiveaimperformfirstmethodologicallyrigoroustrialMETHODS:patient-injector-evaluator-blindedincluded28adultlong-standingtreatment-resistantbaselineperiodeitherfixedsitespainsideSecond≥8Patientsthereafteranother8detailedcalendarfilledquality-of-lifeQoLquestionnairesalgometrymobilitymeasurementsRESULTS:differencemixedlinearmodel084regardprimaryend-pointreductiondaysmoderatesevereSixwithdrewsecondintention-to-treatITTgavesimilarresult27differencesfavouringsecondaryefficacymeasuresSide-effectsminorshort-lastingCONCLUSION:seembeneficialtreatmentheadache:double-blind

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