NCT02358902

Effect of Transcranial Direct Current Stimulation Associated With Aerobic Exercise Training for Patients With Fibromyalgia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study consists of a randomized, double-blind, clinical trial with two months' duration of follow-up. The variable used was the VAS for pain, considering the values of any difference between the data before and after stimulation.

Detailed description

The average between the analyzed values was 1.20, with a standard deviation of 0.84, taking into account a type I error of 5%, a type II error of 10% and a power of 80%. From the sample calculation was found an n = 10 for each group. The sample is amplified in order to avoid possible effects of dropout ending with a n = 15 in each group with a total N = 45. Randomization was performed by a blinded therapist using sealed envelopes for each individual. The subjects will be divided into three intervention groups: tDCS (tDCS - DC stimulator, Neurocom, Germany) / AE Group, in which will receive active intervention of aerobic exercise training and active tDCS intervention. AE group, which will receive active intervention of aerobic exercise and placebo tDCS. And tDCS group, which will receive placebo AE and active intervention for tDCS. Participants will be blinded to the intervention groups as well as therapists involved in the evaluation process. The evaluation methods were carried out one week before the beginning of the intervention (baseline) for all variables. After the first week of intervention (neuromodulatory period) was performed ratings for level of cortical excitability (T1), and after the end of the one month period of intervention for all variables (T2). Follow-up evaluations were conducted one month (T3) and two months (T4) after the end of the intervention period."

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DEVICE	tDCS	tDCS - DC stimulator, Neurocom, Germany
PROCEDURE	active intervention of aerobic exercise	different types of aerobic exercise
DEVICE	placebo tDCS	only 30 seconds of cortical stimulaion , with the power turned off for the remaining time (tDCS - DC stimulator, Neurocom, Germany)
PROCEDURE	placebo AE	the procedure was a training on the treadmill, but heart rate was maintained within 5% of the resting heart rate at the minimum speed on the treadmill

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2015-02-09
• Last updated: 2015-02-09