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

Phase 2

Completed

• Conditions: Fibromyalgia
• Interventions: Device: tDCS; Procedure: active intervention of aerobic exercise; Procedure: placebo AE; Device: placebo tDCS

• Registration Number: NCT02358902
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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."

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2015-02-03
• Last Update Submitted: 2015-02-03
• Study First Posted: 2015-02-09
• Last Update Posted: 2015-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Patients diagnosed with Fibromyalgia according to the American College of Rheumatology
2. Have completed high school
3. Age between 18 and 65 years old

Exclusion Criteria

1. Were on medication for pain control for less than two months
2. In treatment of depression for less than two months
3. Patients with epilepsy, psychiatric disorders or who have any recent episode of neurologic disorders such as idiopathic syncope
4. Pregnant women and infants
5. Possessing metallic implant in the brain
6. In use of illicit drugs
7. That were in some kind of physical treatment for less than two months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	tDCS	tDCS group which will receive placebo AE and active intervention for tDCS (tDCS - DC stimulator, Neurocom, Germany)
Group A	tDCS	tDCS (tDCS - DC stimulator, Neurocom, Germany) / AE Group in which will receive active intervention of aerobic exercise training and active tDCS intervention
Group B	active intervention of aerobic exercise	AE group which will receive active intervention of aerobic exercise and placebo tDCS (tDCS - DC stimulator, Neurocom, Germany)
Group A	active intervention of aerobic exercise	tDCS (tDCS - DC stimulator, Neurocom, Germany) / AE Group in which will receive active intervention of aerobic exercise training and active tDCS intervention
Group C	placebo AE	tDCS group which will receive placebo AE and active intervention for tDCS (tDCS - DC stimulator, Neurocom, Germany)
Group B	placebo tDCS	AE group which will receive active intervention of aerobic exercise and placebo tDCS (tDCS - DC stimulator, Neurocom, Germany)

Primary Outcome Measures

Name	Time	Method
Change in Visual Numeric Scale (VNS)	Up to 2 months	Pain intensity is measured using a scale from 0 to 10. A straight 10 cm line is displayed for the subject enumerated from zero to 10, where zero represents no pain and 10 the worst pain possible. Subjects should mark the number that most represents the symptom of pain at the moment. Outcome will be measured 24 hours after each intervention session, after 1 month of the end of protocol and 2 months after the end of protocol for evaluation of long term effects.

Secondary Outcome Measures

Name	Time	Method
Change in Visual Numeric Scale for Anxiety	Up to 2 months	This scale has a straight 10 cm enumerated from zero to 10, where zero represents not anxious and 10 the most anxious possible. Subjects should mark the number that most represents the anxiety level at the moment. Outcome will be measured 24 hours after each intervention session, after 1 month of the end of protocol and 2 months after the end of protocol for evaluation of long term effects.