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

NCT ID: NCT02358902

Last Updated: 2015-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-11-30

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."

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

tDCS - DC stimulator, Neurocom, Germany

active intervention of aerobic exercise

Intervention Type: PROCEDURE

different types of aerobic exercise

Group B

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

Group Type: EXPERIMENTAL

active intervention of aerobic exercise

Intervention Type: PROCEDURE

different types of aerobic exercise

placebo tDCS

Intervention Type: DEVICE

only 30 seconds of cortical stimulaion , with the power turned off for the remaining time (tDCS - DC stimulator, Neurocom, Germany)

Group C

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

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

tDCS - DC stimulator, Neurocom, Germany

placebo AE

Intervention Type: PROCEDURE

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

Interventions

tDCS

tDCS - DC stimulator, Neurocom, Germany

Intervention Type: DEVICE

active intervention of aerobic exercise

different types of aerobic exercise

Intervention Type: PROCEDURE

placebo tDCS

only 30 seconds of cortical stimulaion , with the power turned off for the remaining time (tDCS - DC stimulator, Neurocom, Germany)

Intervention Type: DEVICE

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcel Simis, MD PhD

Role: STUDY_CHAIR

Institute of Physical Medicine and Rehabilitation, Clinicas Hospital, Faculty of Medicine, University of Sao Paulo

References

Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L, Bravo R, Rigonatti SP, Freedman SD, Nitsche MA, Pascual-Leone A, Boggio PS. A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. Arthritis Rheum. 2006 Dec;54(12):3988-98. doi: 10.1002/art.22195.

Reference Type: RESULT

PMID: 17133529 (View on PubMed)

Other Identifiers

08603612.0.0000.5511

Identifier Type: -

Identifier Source: org_study_id