This study aimed to assess the effectiveness of the tDCS protocol as an adjuvant therapy for reducing chronic headache in SLE. It is also hoped that this study will obtain an effective tDCS protocol for chronic headache.
The whole procedure will run for 20 weeks, divided into 3 parts (Pre-intervention, Intervention, and Post-intervention)
Pre-intervention (weeks 0-4) to conduct screening, provide informed consent, and also baseline assessment. Participants will come in weeks 0 and 4.
Intervention (weeks 4-8) to perform the TDCS intervention, record and assess outcomes, and assess if an unwanted event occurs. Participants will come 2 times per week, from week 4 to 8
Post-intervention (weeks 8-20) for continued outcome assessment. Participants will come on weeks 8, 12, 16, and 20
The total number of visits from each participant is 14 times
SLE patients who meet the inclusion criteria and have signed the consent will be subjected to a baseline assessment (weeks 0-4) followed by randomization into 4 groups/arms consisting of 3 treatments (getting standard therapy for SLE and other diseases that have been obtained so far, plus the administration of tDCS at DLPC, M1, S1) and 1 control group that got sham tDCS.
If the tDCS intervention shows effective and safe results, then the subject in the control group (the group that received the sham) will be offered to be given the intervention method at the end of the study.
Any unwanted event (adverse event) that occurs will be recorded. If an undesirable event occurs, a written report will be made to the ethics committee.
Demographic data will be presented descriptively according to the type of data. Normality test will be performed with Shapiro-Wilkins. To find out the changes in the frequency of headaches in the four groups, an analysis using one-way Anova was carried out followed by Bonferroni post hoc analysis with a significance level of 0.05. The effect size of each group will also be analyzed with Cohen's d=02 (small effect), 0.5 (medium) and 0.8 (large) parameters.
Data analysis will be carried out using SPSS 23.0 and GraphPad software.
