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

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Fibromyalgia

Treatments: Procedure: placebo AE; Procedure: active intervention of aerobic exercise; Device: tDCS; Device: placebo tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT02358902

08603612.0.0000.5511

Details and patient eligibility

About

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.

Full 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."

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

Group A

Experimental group

Description:

tDCS (tDCS - DC stimulator, Neurocom, Germany) / AE Group in which will receive active intervention of aerobic exercise training and active tDCS intervention

Treatment:

Device: tDCS

Procedure: active intervention of aerobic exercise

Group B

Experimental group

Description:

AE group which will receive active intervention of aerobic exercise and placebo tDCS (tDCS - DC stimulator, Neurocom, Germany)

Treatment:

Device: placebo tDCS

Procedure: active intervention of aerobic exercise

Group C

Experimental group

Description:

tDCS group which will receive placebo AE and active intervention for tDCS (tDCS - DC stimulator, Neurocom, Germany)

Treatment:

Device: tDCS

Procedure: placebo AE