Therapeutic effect of red laser to promote relieve of headache

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2019
INTERVENTION: Device Low‐Level Light Therapy Of the 63 people summoned to the meeting, 43 people attended and agreed to the terms of participation (Informed Consent Form). Of this total, 2 people started the first stage of treatment, but were excluded because they did not meet the criteria required by the treatment protocol, given by Consort. Thus, 41 people were treated during the 5 months of treatment, in which 21 people were part of group A and 20 in group B, with the minimum required of 17 participants per group. In the first stage, group A received placebo and group B received phototherapy. In the second stage, A received phototherapy and B, placebo Each participant was attended 19 times, 1 meeting to explain the treatment protocol, 1 meeting for medical evaluation, 16 meetings for initial evaluation, treatment sessions and 1 meeting for the conclusion of the protocol. After undergoing medical evaluation, the patient was instructed to complete the Pain Diary for one month, during which no therapy was performed. At the end of this first month, the first treatment session was scheduled. On the first day of treatment, for both groups, a blood collection was performed and after collection, the patient was comfortably positioned to receive the treatment application. The low intensity laser with a wavelength of 660nm with 100mW of power was used in the radial artery of the patients for a period determined according to the individual calculation of body mass index (BMI) + volemia. On average there was a time of about 30 minutes of treatment to reach the circulating blood of these patients. After this session, the other sessions of the first stage were scheduled, totaling 8 treatment sessions (2x / week) in the second month. In the last session of this first phase, after receiving the laser application, a new blood collection was performed. In the third month the washout period (30 days) occurred, ie both groups received no treatment. In the fourth month treatment was restarted, but CONDITION: G00‐G99 Migraine Patients with migraine or e, a pathological condition of nervous system. ; Migraine PRIMARY OUTCOME: Assessment of headache intensity, presence of triggers, pain sites or other factors during migraine occurrence, verified by pain diary before, during and after treatment. SECONDARY OUTCOME: Changes in the level of oxidative stress (Superoxide dismutase ‐ SOD, Catalase, TIOIS) and nitrosative stress (nitrite and nitrate) in the blood before and after treatment. To assess migraine‐related disability with the Migraine Disability Assessment Program (MIDAS) Questionnaire (FRAGOSO, 2002) at the end of treatment. To assess patient satisfaction and change perception regarding their disease condition by the Global Patient Impression Scale (PGIC) (HURST; BOLTON, 2004) at the end of treatment. To evaluate the presence and severity of allodynia through the 12 ‐ Item Allodynia Symptom Checklist (ASC ‐ 12) ‐ Brazilian Version (FLORENCE et al., 2012) at the end of treatment. INCLUSION CRITERIA: Only participants who meet the criteria required by the International Headache Society for migraine‐type headache (CLASS. SIC, 2014); age over 18 years and above 80 years; complain of headache for more than six months and recurrent episodes; report 3 episodes of migraine per month; reported onset of migraine before age 50; have at least 3 months of history and 2‐8 attacks per month, with progression of moderate to severe pain symptoms lasting more than 2h; report headache medication use 14 days / month within 3 months prior to study; If they use migraine prophylaxis, you should be stable for 30 days before and throughout the study.
Epistemonikos ID: 26e2025385526935144d6f1c069c4b78987c1053
First added on: Aug 24, 2024