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Transcranial Direct Current Stimulation Associated With Pilates in Low Back Pain

NCT ID: NCT05651763

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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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

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Low Back Pain Transcranial Direct Current Stimulation

Keywords

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Transcranial Direct Current Stimulation Low back pain Exercises Chronic pain Performance Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

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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

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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

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Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role lead

Responsible Party

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Jamilson Simões Brasileiro

Professor of Physiotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Jamilson S Brasileiro, PhD

Role: CONTACT

Phone: +55 84 3342-2008

Email: [email protected]

Other Identifiers

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SRAG2022

Identifier Type: -

Identifier Source: org_study_id