Non-Pharmacological Treatment for Primary Headaches Prevention and Lifestyle Changes in a Low-Income Community of Brazil: A Randomized Clinical Trial

Background Primary headaches can be reduced by lifestyle changes, such as stress management and physical activity. However, access to programs focused on behavioral interventions is limited in underserved, poor communities. Objectives We performed a randomized open-label clinical trial to test the therapeutic and behavioral effects of aerobic exercise, relaxation, or the combination of both, in individuals with primary headaches of a small, low-income community of the Brazilian Amazon. Methods Participants were screened from the riverine/rural population, and individuals with primary headache were included. We assessed clinical characteristics and physical activity levels. Interventions were delivery 3 times/week for 6 months. The primary outcome variable was changes in days with headache, while changes in duration of attacks, pain intensity, and physical activity levels were secondary outcomes variables. Results Seven hundred and ninety individuals were screened (15.3% of rural/riverine population). Seventy-four participants were randomly assigned to relaxation (n = 25), physical activity orientation program (n = 25), or both (n = 24) interventions. Intention to treat analyses showed all interventions as effective to reduce days with headaches and duration of attacks (both P < .01). Pain intensity was reduced only in relaxation and relaxation + physical activity groups (both P < .01). Physical activity levels increased only in the relaxation + physical activity group (P < .05). Conclusions Non-pharmacological interventions such as physical activity and relaxation are effective for reducing headaches, while combining such interventions promote health behavior toward higher physical activity levels in low-income populations with primary headaches. Clinical Trial Registration number: SGPP 1544.