Abstract text (incl. figure legends and references)

Aim:To assess the efficacy of pain neuroscience education (PNE) combined with physiotherapy (PT) compared to physiotherapy alone for the management of migraine.

Background: Physiotherapy can significantly reduce the intensity and frequency of migraine, but the level of evidence is low. PNE might pose a promising treatment for migraine patients, as it addresses migraine as a chronic pain disease.

Methods: In this randomized controlled trial, patients with migraine received PT+PNE or PT alone. The primary outcomes were reduction of headache frequency (days/month) migraine days and migraine associated disability. Secondary outcomes included migraine specific quality of life, depression, neck pain and the acquired knowledge on the neurophysiology of pain. The treatments were preceded by a three-month waiting period during which a headache diary was kept. A two-way repeated ANOVA was used to assess between- and within-subjects factors and interactions, including group and time for baseline, post-treatment and 3-month follow-up.

Results: 82 patients participated in the study and showed a significant decrease of headache frequency post-treatment and at 3-months follow-up (F2,158 = 4.12, p = 0.02) (effect size d= 0.46). There was no difference between groups (F2,158 = 1.35, p = 0.26). Frequency of migraine days, only, showed a significant difference between groups (F2,158= 5.04, p = 0.008) with a greater reduction in the PT+PNE group (medium effect size d= 0.5). Migraine associated disability showed a significant decrease at 3-months follow-up (strong effect size d= 1.15) (F1,80 = 24.08, p < 0.001 (d= 1.15) and no difference between groups (F1,80 = 0.30, p = 0.583). Secondary outcomes demonstrated a significant effect of time with no interaction between time and group.

Conclusion: PNE does not significantly add to the effect of physiotherapy regarding the reduction of headache frequency and migraine associated disability but may reduce the number of migraine days.