This is a randomized and blind clinical trial, whose objective is to evaluate the effects of transcranial stimulation by direct current associated with exercises based on the pilates method on the performance of patients with chronic low back pain.
Considered a public health problem, low back pain is globally presented as a symptomatology of high prevalence, incidence and recurrence. In addition, it is responsible for a large part of disabilities, reduced functional performance, absences from work and impaired quality of life, which brings biopsychosocial impacts to the affected subjects. Treatments that relieve the symptoms of these patients are of great importance to improve the quality of life of these individuals. Thus, this study aims to evaluate the effects of transcranial direct current stimulation associated with Pilates based exercise on chronic low back pain. This is a randomized clinical trial that will be composed of women between 18 and 65 years of age, with a history of low back pain for more than 12 weeks and a minimum pain intensity equal to 3 cm on the numerical pain scale. The volunteers will be randomized into two distinct groups: stimulation + exercise group (EG - will perform a Pilates based exercise protocol combined with transcranial direct current stimulation) and sham stimulation + exercise group (SG - will perform the same exercise program combined with sham stimulation). The interventions, regardless of the group, will be carried out three times a week for four weeks. Participants will be submitted to three assessments: the first (T0) will be performed before the treatment protocols; the second (T1) will be performed after the four weeks of intervention; and the third (T2) will be a follow-up one month after the end of the treatment protocol. Pain sensation, performance, pressure pain threshold, use will be evaluated. For the statistical analysis, a mixed model ANOVA will be performed for the inter and intragroup comparison, with Tukey's post hoc, considering a significance level of 5%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
42
Exercise protocol + application of active direct current stimulation for 30 minutes.
Sham Transcranial direct current stimulation Exercise protocol + application of simulation of direct current stimulation for 30 minutes. The stimulator will be turned off after 30 seconds and the volunteers will not receive current for the rest of the session.
Pain intensity (numerical pain rating scale)
Pain intensity measured by numerical pain rating scale, measured on an 11-point where 0=no pain and 10=worst possible pain.
Time frame: up to 1 month of follow-up
Pressure pain threshold
Pressure pain threshold measured by pressure algometer.
Time frame: A pressure pain four weeks after intervention and 1 month of follow-up
Root Mean Square (RMS)
Analyze of the electromyographic activity of the back muscles
Time frame: Evaluation of RMS four weeks after intervention and 1 month of follow-up
Peak of muscular torque
Evaluate the peak of muscular torque using the hand-held dynamometer.
Time frame: Evaluation of Peak of muscular torque four weeks after intervention and 1 month of follow-up
Back muscle fatigue
Measure the back muscular resistance to fatigue using the Ito test
Time frame: Evaluation of Back muscle fatigue four weeks after intervention and 1 month of follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.