Licia Grazzi1, Susanna Usai1, Nadia Bolognini2,3, Eleonora Grignani1, Emanuela Sansone1, Irene Tramacere4, Angelo Maravita2, Giuseppe Lauria1,5. 1. Neuroalgology Unit, Headache Centre, Fondazione IRCCS Istituto Neurologico "Carlo Besta", Milan, Italy. 2. Department of Psychology and Milan Center for Neuroscience, University of Milano-Bicocca, Milan, Italy. 3. IRCCS Istituto Auxologico Italiano, Neuropsychology Laboratory, Milan, Italy. 4. Department of Research and Clinical Development, Scientific Directorate, Fondazione IRCCS Istituto Neurologico "Carlo Besta", Milan, Italy. 5. Department of Biomedical and Clinical Sciences "Luigi Sacco", University of Milan, Milan, Italy.
Abstract
BACKGROUND:Transcranial direct current stimulation was suggested to provide beneficial effects in chronic migraine, a condition often associated with medication overuse for which no long-term therapy is available. METHODS: We conducted a randomised controlled trial to assess long-term efficacy of transcranial direct current stimulation. Adults diagnosed with chronic migraine and medication overuse were assigned to receive in a 1:1:1 ratio anodal, cathodal, or sham transcranial direct current stimulation daily for five consecutive days, along with standardised drug withdrawal protocol. Primary outcome was 50% reduction of days of headache per month at 12 months. Co-secondary outcomes were 50% reduction of days of headache per month at 6 months, reduction of analgesic intake per month, and change in disability and quality of life, catastrophising, depression, state and trait anxiety, dependence attitude and allodynia intensity. Patients were not allowed to take any migraine prophylaxis drug for the entire study period. RESULTS: We randomly allocated 135 patients to anodal (44), cathodal (45), and sham (46) transcranial direct current stimulation. At 6 and 12 months, the percentage of reduction of days of headache and number of analgesics per month ranged between 48.5% and 64.7%, without differences between transcranial direct current stimulation (cathodal, anodal, or the results obtained from the two arms of treatment, anodal plus cathodal) and sham. Catastrophising attitude significantly reduced at 12 months in all groups. There was no difference for the other secondary outcomes. CONCLUSIONS:Transcranial direct current stimulation did not influence the short and long-term course of chronic migraine with medication overuse after acute drug withdrawal. Behavioral and educational measures and support for patients' pain management could provide long-term improvement and low relapse rate.Trial registration number NCT04228809.
RCT Entities:
BACKGROUND: Transcranial direct current stimulation was suggested to provide beneficial effects in chronic migraine, a condition often associated with medication overuse for which no long-term therapy is available. METHODS: We conducted a randomised controlled trial to assess long-term efficacy of transcranial direct current stimulation. Adults diagnosed with chronic migraine and medication overuse were assigned to receive in a 1:1:1 ratio anodal, cathodal, or sham transcranial direct current stimulation daily for five consecutive days, along with standardised drug withdrawal protocol. Primary outcome was 50% reduction of days of headache per month at 12 months. Co-secondary outcomes were 50% reduction of days of headache per month at 6 months, reduction of analgesic intake per month, and change in disability and quality of life, catastrophising, depression, state and trait anxiety, dependence attitude and allodynia intensity. Patients were not allowed to take any migraine prophylaxis drug for the entire study period. RESULTS: We randomly allocated 135 patients to anodal (44), cathodal (45), and sham (46) transcranial direct current stimulation. At 6 and 12 months, the percentage of reduction of days of headache and number of analgesics per month ranged between 48.5% and 64.7%, without differences between transcranial direct current stimulation (cathodal, anodal, or the results obtained from the two arms of treatment, anodal plus cathodal) and sham. Catastrophising attitude significantly reduced at 12 months in all groups. There was no difference for the other secondary outcomes. CONCLUSIONS: Transcranial direct current stimulation did not influence the short and long-term course of chronic migraine with medication overuse after acute drug withdrawal. Behavioral and educational measures and support for patients' pain management could provide long-term improvement and low relapse rate.Trial registration number NCT04228809.
Entities:
Keywords:
Non-invasive stimulation; drug withdrawal; headache; pain management
Authors: Licia Grazzi; Claudia Toppo; Domenico D'Amico; Matilde Leonardi; Paolo Martelletti; Alberto Raggi; Erika Guastafierro Journal: Int J Environ Res Public Health Date: 2021-02-05 Impact factor: 3.390