Transcranial Direct Current Stimulation Associated With Pilates in Low Back Pain

NCT ID: NCT05651763

Last Updated: 2022-12-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2023-12-31

Brief 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

Study Design

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

Study Groups

Stimulation and exercise group

30-minute exercise program (based on Pilates method) associated with active transcranial direct current stimulation.

Group Type: EXPERIMENTAL

Stimulation and exercise group

Intervention Type: OTHER

Exercise protocol + application of active direct current stimulation for 30 minutes.

Exercise and sham stimulation group

30-minute exercise program (based on Pilates method) associated with sham transcranial direct current stimulation.

Group Type: SHAM_COMPARATOR

Exercise and sham stimulation group

Intervention Type: OTHER

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.

Interventions

Stimulation and exercise group

Exercise protocol + application of active direct current stimulation for 30 minutes.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Women with chronic nonspecific low back pain (for more than 12 weeks) and minimum pain intensity of 3 on numerical pain rating scale

Exclusion Criteria

• diagnosis of fracture and spine pathologies, fibromyalgia, spine surgery in the last year;
• low cognitive level assessed by the Mini Mental State Examination;
• presence of central neurological diseases (such as Parkinson's and stroke) or psychiatric (such as depression or schizophrenia);
• history of epileptic illness;
• seizure history;
• brain implants;
• pacemaker;
• pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: lead

Responsible Party

Jamilson Simões Brasileiro

Professor of Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jamilson S Brasileiro, PhD

Role: CONTACT

brasileiro@ufrnet.br

+55 84 3342-2008

Other Identifiers

SRAG2022

Identifier Type: -

Identifier Source: org_study_id