RESUMEN
BACKGROUND: Biofeedback-treatment for primary headache is highly recommended. Its expenses are mostly not or not completely covered by health funds, hindering the implementation in the care system. This randomized controlled study aimed at evaluating the efficacy of a biofeedback-treatment for primary headache in the outpatient care system all over Germany. METHODS: The participants were divided into a direct treatment-group (n=41) and a waiting control-group (n=29). The treatment was carried out for 8-11 sessions with vasoconstriction-/vasodilation training for migraine, with electromyography training for headache of the tension type (diagnosis according to the criteria of the International Headache Association). Headache characteristics (frequency, duration, intensity) were collected via headache-diary before, during and after the treatment and headache specific disability using the Pain Disability Index before and after the treatment. The waiting group stated additional information of the questionnaires about 3 months before and again ultimately before the start of the treatment. Measurement of the headache specific self-efficacy (Headache Management Self-efficacy Scale) took place every second session. For the collected parameters the effect sizes f2 or r were computed before in comparison to after the treatment and comparing the treatment-group to the waiting-group. RESULTS: Headache characteristics decreased during the time of the study significantly linearly with medium to strong effects (frequency f2=0.302, p<0.001, duration f2=0.186, p<0.001, mean intensity f2=0.502, p<0.001, maximal intensity f2=0.546, p<0.001). Using biofeedback the self-efficacy rose significantly (p<0.001, r=0.782), even compared to the waiting time (p<0.001, r=0.604). Additionally the handling of pain, the psychological disability and the disability in everyday life improved significantly. DISCUSSION AND CONCLUSION: Overall the effects were comparable to already existing studies. Therefore biofeedback turned out to be efficient against migraine and tension-type headache in the out-patient care setting. By that a better integration in the care system seems to be qualified.