NCT05651763

Transcranial Direct Current Stimulation Associated With Pilates in Low Back Pain

The Effects of Transcranial Direct Current Stimulation Associated With Pilates Based Exercise in Performance of Patients With Chronic Low Back Pain

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Universidade Federal do Rio Grande do Norte · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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%.

Conditions

• Low Back Pain
• Transcranial Direct Current Stimulation

Interventions

Type	Name	Description
OTHER	Stimulation and exercise group	Exercise protocol + application of active direct current stimulation for 30 minutes.
OTHER	Exercise and sham stimulation group	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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2022-12-15
• Last updated: 2022-12-15