Open AccessOccipital Nerve Stimulation for Chronic Migraine: A Randomized Trial
Author(s) -
Gerardo Serra
Publication year - 2012
Publication title -
pain physician
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.31
H-Index - 99
eISSN - 2150-1149
pISSN - 1533-3159
DOI - 10.36076/ppj.2012/15/245
Subject(s) - medicine , triptans , chronic migraine , randomized controlled trial , migraine , occipital nerve stimulation , quality of life (healthcare) , headaches , stimulation , anesthesia , physical therapy , surgery , alternative medicine , nursing , pathology
Background: Chronic migraine (CM) and medication overuse headache (MOH) are disablingconditions that may be only partially managed with conservative treatments. Occipital nervestimulation (ONS) is an innovative treatment for headache disorders.Objectives: To investigate the safety and efficacy of ONS for CM and MOH patients and toevaluate changes in disability, quality of life, and drug intake in implanted patients.Study Design: Prospective, randomized cross-over study.Methods: Eligible patients who responded to a stimulation trial underwent device implantationand were randomized to “Stimulation On” and “Stimulation Off” arms. Patients crossed overafter one month, or when their headaches worsened. Stimulation was then switched On for allpatients. Disability as measured by the Migraine Disability Assessment (MIDAS), quality of life(SF-36), and drug intake (patient’s diary) were assessed over a one-year follow-up.Results: Thirty-four patients (76% women, 34% men, mean age: 46 ± 11 years) wereenrolled; 30 were randomized and 29 completed the study. Headache intensity and frequencywere significantly lower in the On arm than in the Off arm (P < 0.05) and decreased fromthe baseline to each follow-up visit in all patients with Stimulation On (median MIDAS A andB scores: baseline = 70 and 8; one-year follow-up = 14 and 5, P < 0.001). Quality of lifesignificantly improved (P < 0.05) during the study. Triptans and nonsteroidal anti-inflammatorydrug use fell dramatically from the baseline (20 and 25.5 doses/month) to each follow-up visit(3 and 2 doses/month at one year, P < 0.001). A total of 5 adverse events occurred: 2 infectionsand 3 lead migrations.Limitations: Single-centre study, relatively small number of patients, absence of a controlgroup.Conclusions: According to the results obtained, ONS appears to be a safe and effectivetreatment for carefully selected CM and MOH patients.Key words: Occipital nerve stimulation, chronic migraine, headache attacks, quality of life,cross-over