The effect of Conventional Transcutaneous Electric Nerve Stimulation (TENS) for treatment of Migraine crisis

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2018
INTERVENTION: Device E02.331.800 Experimental group: 40 patients of both sexes, diagnosed with migraine, will receive a portable transcutaneous electroneuromodulation device, will take the device (with the user manual, moist tissues and a 2nd pathway folder) and the questionnaires before and after the and will be oriented to use only during migraine attacks, non‐invasively, transcutaneously, in the forehead region, receiving follow‐up once a month for 4 months to control the research, with application of HIT‐6 of impact of the headache) to evaluate the quality of life. Control group: 40 patients of both sexes, diagnosed with migraine, will receive a portable transcutaneous electroneuromodulation placebo device, will take the device (with the user manual, moist tissues and a folder with the 2nd ICU track and the before and after questionnaires to be used only during migraine attacks, non‐invasively, transcutaneously, in the forehead region, receiving follow‐up once a month for 4 months to control the research, with application of HIT‐6 ( Headache impact test) to assess the quality of life. CONDITION: G00‐G99 Migraine with and without aura ; G43 PRIMARY OUTCOME: Untreated electronuromodulation device during migration seizures with improvement of at least 3 points on the analog pain scale, activity scale and HIT‐6 quality of life questionnaire. SECONDARY OUTCOME: Secondary outcomes are not expected INCLUSION CRITERIA: 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 compl
Epistemonikos ID: 219a7f062f268f14c99b4fd6d23ede8ceab8dc88
First added on: Aug 24, 2024