Effect of exercise protocol for strengthen cervical muscles in migraineurs compared with placebo group - Randomized Controlled Trial

Abstract

Objective: To verify the effect of cervical muscles exercises in the frequency and severity of headache attacks in individuals with migraine compared to the placebo intervention. Methods: Up to 42 participants of both sexes will be included in the study. They should have between 18 and 55 years old and the diagnosis of migraine performed by an experienced neurologist, according to the 3rd edition of the International Classification of Headaches. The included subjects will undergo a screening assessment including demographic, anthropometric and migraine characteristics. Volunteers will also complete for 30 days a headache diary, in order to provide information regarding the migraine attacks frequency and intensity. In addition, the questionnaires Neck Disability Index, Migraine Disability Assessment, Tampa Scale for Kinesiophobia, Patient-specific Functional Scale and 12 item Allodynia Symptom Checklist will be administered. After 30 days, the volunteers will return for a kinetic-functional evaluation of the cervical muscles, which consists of range of motion assessment of the cervical spine, pain threshold of the craniocervical muscles and electromyographic activity of the muscles sternocleidomastoid, anterior scalene, splenius of the head and upper trapezius. The electromyographic signals of these muscles will be recorded during the craniocervical flexion test, muscle strength test and endurance test of the cervical muscles. Then, participants will be randomized into two groups of 21 participants each: intervention group and placebo group. The intervention group will perform a protocol composed of strength exercises for the cervical flexor and extensor muscles, divided into two stages. The first stage will last 6 weeks and exercises will be focused in the deep neck muscles. The second stage will last 2 weeks and exercises will be focused deep and superficial neck muscles. In both phases, volunteers will be supervised and guided by an experienced physiotherapist and the sessions will occur once a week with average duration of 20 minutes. Volunteers will be instructed to perform neck strength and stretching exercises twice a day at home, following an illustrative brochure that they will receive. The subjects of the placebo group will receive a disconnected therapeutic ultrasound application in the upper trapezius medial portion, bilaterally for 9 minutes each, for 8 weeks. As in the intervention group, participants will be followed up in weekly sessions lasting approximately 20 minutes. The placebo group will receive also an illustrative brochure containing only cervical stretching exercises and they will be instructed to perform them once a day. At the end of the eight weeks of treatment, the volunteers of both groups will deliver the headache diaries in order to inform the frequency and severity of migraine attacks. A follow-up will be carried out through telephone calls after one, two and three months of the end of sessions in both groups in order to monitor the headache attacks frequency and severity. After six weeks of treatment, both groups will be reevaluated in the following secondary outcomes: electromyographic assessment during the craniocervical flexion test and global perception of change questionnaire administration. Finally, after the eight weeks of treatment, all participants will go through the final evaluation that will include all items of the initial evaluation. The volunteers of the placebo group may, if interested, perform the exercise protocol after the follow up completion.