title: Biofeedback in the prophylactic treatment of medication overuse headache: a pilot randomized controlled trial.
abstract: BACKGROUND
  Medication overuse headache (MOH) is a major clinical concern and a common health risk. Recent literature stressed the need to manage chronic headache by using integrated biobehavioral approaches. Few studies evaluated how biofeedback can be useful in MOH. The aim of the study is to evaluate in a randomized, controlled, single-blind trial the effects of biofeedback associated with traditional pharmacological therapy in the prophylactic treatment of MOH.
  
  
  METHODS
  Twenty-seven subjects were randomized to frontal electromyographic (EMG) biofeedback associated with prophylactic pharmacological therapy (Bfb Group) or to pharmacological treatment alone (Control Group). The primary outcome was to evaluate the number of patients that return episodic after treatment. Secondly we evaluate the effects of frontal EMG BFB on frequency of headache and analgesic intake. Changes in coping strategies and in EMG frontalis tension were also evaluated. ANOVA was performed on all the variables of interest.
  
  
  RESULTS
  Our results indicate that at the end of treatment the number of patients that returned episodic in the Bfb group was significantly higher than in the Control group. Patients in the Bfb group differed from the Control group in headache frequency, amount of drug intake and active coping with pain. These outcomes were confirmed also after 4 months of follow-up. No significant effects were observed in EMG recordings.
  
  
  CONCLUSIONS
  Biofeedback added to traditional pharmacological therapy in the treatment of MOH is a promising approach for reducing headache frequency and analgesic intake. Modification of coping cognitions in the Bfb group, as an adjunct mechanism of self-regulation, needs more evaluations to understand the role of biofeedback in changing maladaptive psychophysiological responses.
authors.affiliation: Department of Biomedical and Neuromotor Sciences DIBINEM, University of Bologna, Bologna, Italy.|Service for the Diagnosis and Treatment of Eating Disorders, Service for the Diagnosis and Treatment of Anxiety and Psychosomatic Disorders, Centro Gruber, Bologna, Italy.
authors.forename: Marialuisa
authors.initials: M
authors.lastname: Rausa
authors.affiliation: Service for the Diagnosis and Treatment of Eating Disorders, Service for the Diagnosis and Treatment of Anxiety and Psychosomatic Disorders, Centro Gruber, Bologna, Italy.|Department of General Psychology, University of Padova, Padova, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Palomba
authors.affiliation: Padiglione G, Bellaria Hospital, IRCCS Institute of Neurological Sciences of Bologna, Via Altura 3, 40139, Bologna, Italy.
authors.forename: Sabina
authors.initials: S
authors.lastname: Cevoli
authors.affiliation: Service for the Diagnosis and Treatment of Eating Disorders, Service for the Diagnosis and Treatment of Anxiety and Psychosomatic Disorders, Centro Gruber, Bologna, Italy.
authors.forename: Luana
authors.initials: L
authors.lastname: Lazzerini
authors.affiliation: Neurology, AUSL (Local Health Service) of Ferrara, Ferrara, Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Sancisi
authors.affiliation: Department of Biomedical and Neuromotor Sciences DIBINEM, University of Bologna, Bologna, Italy.|Padiglione G, Bellaria Hospital, IRCCS Institute of Neurological Sciences of Bologna, Via Altura 3, 40139, Bologna, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Cortelli
authors.affiliation: Department of Biomedical and Neuromotor Sciences DIBINEM, University of Bologna, Bologna, Italy. giulia.pierangeli@unibo.it.|Padiglione G, Bellaria Hospital, IRCCS Institute of Neurological Sciences of Bologna, Via Altura 3, 40139, Bologna, Italy. giulia.pierangeli@unibo.it.
authors.forename: Giulia
authors.identifier: http://orcid.org/0000-0003-4845-0812
authors.initials: G
authors.lastname: Pierangeli
mesh_terms: D000328:Adult; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use; D003131:Combined Modality Therapy; D005260:Female; D051271:Headache Disorders, Secondary / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D058765:Neurofeedback / Q000379:methods*; D017063:Outcome Assessment, Health Care; D010865:Pilot Projects; D016037:Single-Blind Method
chemical_list: D000700:Analgesics
keywords: Biofeedback; Chronic migraine; Coping strategies; Medication overuse headache; Preventive therapy; Psychological treatment