The combined effect of transcutaneous electrical nerve stimulation and massage therapy on disease-related disability in people with migraine headaches

Determining the combined effect of Transcutaneous Electrical Nerve Stimulation (TENS) and massage therapy on disease-related disability in patients with migraine headache

Randomized Clinical trial study with a control group, on 200 patients and randomized by List Randomization site

The study was done in clinic of Dr. Bidaki, a neurologist in Shiraz. Tennis is performed by a Memos-T-VNS machine and massage in 6 steps according to the protocol

Inclusion Criteria: aged 18-55 years, having chronic migraine criteria according to the International Classification of Headache Disease (ICHD III, 2010), confirmation of the diagnosis of migraine headache by a neurologist, score of 50 and above headache impact test (HIT) and get a score of 11 and more from the Migraine Disability Assessment Questionnaire (MIDAZ), literacy. Exclusion criteria are: any history of tennis, and other complementary or psychological treatment, patients with persistent migraine headaches, and tension, cluster and secondary headache, cancer, pregnancy, lactation, addiction, other chronic disease, and any anatomical and pathological disorders in the ear.

Patients are divided into 4 groups. In group 1, auricular TENS is performed for two days a week at intervals of 2 to 3 days and for 4 weeks on each ear for 5 minutes and a total of 10 minutes in both ears. In group 2, massage intervention is performed for 4 weeks a week, 2 sessions at intervals of 2 to 3 days, 30 minutes. In group 3 for 4 weeks, twice a week for 2 to 3 days, first TENS and then massage according to standard protocols. Control group, will received routine treatment.

Migraine- related disability

block randomize: Eligible people using the List Randomization site at (https://www.sealedenvelope.com/simple- randomiser / v1 / lists) and creating a number of different blocks, In three groups, intervention 1 (auricular tense), intervention 2 (massage), intervention 3 (combination) and control will be allocated. Blocking method will be used to assign individuals to the studied groups. Random allocation by blocking method is to make sure that exactly the same number of patients enter the intervention and control groups at consecutive but equal intervals. The groups will be A, B, C, D. Before assigning people to one of the groups, a list of these letters (A, B, C, D) are formed as blocks. Each of the eligible applicants will be assigned to one of the groups. The advantage of blocked randomization is that the balance of the number of patients in each group is guaranteed. To avoid the predictable risk of assigning people to different groups, blocks of different sizes will be created.