The effect of Conventional Transcutaneous Electric Nerve Stimulation (TENS) for treatment of Migraine crisis
- Conditions
- Migraine with and without aura
- Registration Number
- RBR-9tpwc5
- Lead Sponsor
- Faculdade de Medicina de Botucatu da Universidade Estadual Paulista
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Data analysis completed
- Sex
- Not specified
- Target Recruitment
- Not specified
The selection of patients will be carried out based on electronic medical record research and routine consultations in the head and face ambulatory, following the Guidelines for clinical trials of drug in migraine (IHS, 2012). Patients with a diagnosis of primary headache classified as migraine will be included; And the major subtypes: migraine with aura and migraine without aura; (ICHD-III, 2013), respecting the following criteria:
Migraine without aura: recurrent cephalic disorder in at least five episodes with the following characteristics: duration of 4 to 72 hours, unilateral, pulsatile, moderate or severe intensity, aggravation by routine physical activity and association with nausea and / or photophobia and phonophobia ;Migraine with aura: at least five episodes with features of migraine without aura and preceded or accompanied by neural symptoms. The typical aura occurs from 5 to 60 minutes duration before the onset of pain, unilateral and completely reversible, with visual, sensory or other central nervous system symptoms that usually develop gradually and are usually followed by Headaches with migraine characteristics and associated symptoms. It can be of six different types, namely retinal aura, visual aura, sensory-somesthetic aura, motor aura, aphasic aura and brainstem aura.
The study will invite patients of both genders, aged between 18 and 65 years, age at onset of illness less than 50 years, diagnosed with migraine for at least one year before being recruited to participate in the study. All should be in current treatment with the use of recommended medicines, in stable doses for at least 30 days and that present sporadic crises.The use of these recommended drugs in the literature and guidelines for the prevention of migraine will occur in conventional doses. All predicted classes of drugs may be employed, namely: calcium channel blockers, such as nimodipine, beta-blockers, such as propranolol and atenolol; Tricyclic antidepressants, such as amitriptyline and nortriptyline; And, among the anticonvulsants, only topiramate and sodium valproate. The frequencies of migraine attacks (with the use of the recommended treatment and in stable doses) should be 1 to 6 times a month, with a remission period of at least 48 hours (IHS, 2012).
Patients with the following criteria will be excluded from the sample: Physical or intellectual incapacity to respond to the survey questionnaire, illiterate, diabetic, pacemaker, epileptic, users of illicit substances and those diagnosed with other CNS diseases (IHS, 2012). Other classifications of migraine, such as chronic migraine (over 15 days with headache / month) and overuse of medications, eg, more than 10 days in the use of triptans for acute pain (IHS, 2012).
Ethical patients, ie the acceptable consumption of alcoholic beverages is up to 15 doses / week for men, not exceeding three daily doses and 10 doses / week for women, no more than two doses per day (WHO, 2004).
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The analgesic efficacy of TENS used at home at times of episodic crises of migraine through reduction of the pain score of the scales used.;The results suggest that treatment with TENS during migraine attacks is effective in relieving pain, since the intervention group showed a significant improvement in the pain scale and the functional disability scale with a median score of three points in the (p = 0.001) and in the second month a reduction of two points (p = 0.001). On the other hand, the placebo group most frequently resorted to analgesic rescues and health services during pain crises.
- Secondary Outcome Measures
Name Time Method Aspects related to the safety profile and the tolerability of a portable, disposable and self-employed device used during the occurrence of episodic crises of migraine;<br>To measure the impact on the quality of life of participants treated with TENS by means of the HIT-6 questionnaire.;The intervention method was considered safe and showed good tolerability during its use.<br>However, it was not observed an improvement in the impact of migraine on the quality of life measured by the application of the HIT-6 questionnaire.