Clinical trial NCT02358902: Effect of Transcranial Direct Current Stimulation Associated With Aerobic Exercise Training for Patients With Fibromyalgia
Official title: Effect of Transcranial Direct Current Stimulation Associated With Aerobic Exercise Training for Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Fibromyalgia
Keywords: Transcranial Direct Current Stimulation
Exercise
Fibromyalgia
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: University of Nove de Julho
First posted: 2015-02-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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."

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

Primary outcomes:
measure: Change in Visual Numeric Scale (VNS)
timeFrame: Up to 2 months
Secondary outcomes:
measure: Change in Visual Numeric Scale for Anxiety
timeFrame: Up to 2 months
Other outcomes:
measure: Change in Pressure Pain Threshold (PPT)
timeFrame: Up to 2 months
measure: Change in Diffuse Noxious Inhibitory Control (DNIC-like effects)
timeFrame: Up to 2 months
measure: Change in SF-36 questionnaire of quality of life
timeFrame: Up to 2 months
Locations:
Study officials:
affiliation: Institute of Physical Medicine and Rehabilitation, Clinicas Hospital, Faculty of Medicine, University of Sao Paulo
name: Marcel Simis, MD PhD
role: STUDY_CHAIR
References:
citation: 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.