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Transcranial Direct Current Stimulation Associated With Pilates in Low Back Pain

Primary Purpose

Low Back Pain, Transcranial Direct Current Stimulation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stimulation and exercise group
Exercise and sham stimulation group
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Transcranial Direct Current Stimulation, Low back pain, Exercises, Chronic pain, Performance, Treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Stimulation and exercise group

    Exercise and sham stimulation group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Pressure pain threshold
    Pressure pain threshold measured by pressure algometer.
    Root Mean Square (RMS)
    Analyze of the electromyographic activity of the back muscles
    Peak of muscular torque
    Evaluate the peak of muscular torque using the hand-held dynamometer.
    Back muscle fatigue
    Measure the back muscular resistance to fatigue using the Ito test

    Full Information

    First Posted
    December 6, 2022
    Last Updated
    December 14, 2022
    Sponsor
    Universidade Federal do Rio Grande do Norte
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05651763
    Brief Title
    Transcranial Direct Current Stimulation Associated With Pilates in Low Back Pain
    Official Title
    The Effects of Transcranial Direct Current Stimulation Associated With Pilates Based Exercise in Performance of Patients With Chronic Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Rio Grande do Norte

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain, Transcranial Direct Current Stimulation
    Keywords
    Transcranial Direct Current Stimulation, Low back pain, Exercises, Chronic pain, Performance, Treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Stimulation and exercise group
    Arm Type
    Experimental
    Arm Description
    30-minute exercise program (based on Pilates method) associated with active transcranial direct current stimulation.
    Arm Title
    Exercise and sham stimulation group
    Arm Type
    Sham Comparator
    Arm Description
    30-minute exercise program (based on Pilates method) associated with sham transcranial direct current stimulation.
    Intervention Type
    Other
    Intervention Name(s)
    Stimulation and exercise group
    Intervention Description
    Exercise protocol + application of active direct current stimulation for 30 minutes.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise and sham stimulation group
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pain intensity (numerical pain rating scale)
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Pressure pain threshold
    Description
    Pressure pain threshold measured by pressure algometer.
    Time Frame
    A pressure pain four weeks after intervention and 1 month of follow-up
    Title
    Root Mean Square (RMS)
    Description
    Analyze of the electromyographic activity of the back muscles
    Time Frame
    Evaluation of RMS four weeks after intervention and 1 month of follow-up
    Title
    Peak of muscular torque
    Description
    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
    Title
    Back muscle fatigue
    Description
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jamilson S Brasileiro, PhD
    Phone
    +55 84 3342-2008
    Email
    brasileiro@ufrnet.br

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Transcranial Direct Current Stimulation Associated With Pilates in Low Back Pain

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