Low back pain
Conditions
Interventions
By carrying out the study, it is expected to find a probable influence of osteopathic manipulative treatment (OMT) associated with transcranial direct current stimulation (tDCS) in increasing the pain
F04.669.224.650
Sponsors
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Eligibility
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Both sexes; com idade between 18 to 55 years; that we will present lombar pain for more than 3 months; that it is not associated with any potentially serious illness or condition in accordance with the NICE guidelines (National Institute for Health and Care Excellence – UK, 2016); and that we will agree with your participation not studied by means of the subject of the term of free and informed consent.
Exclusion criteria
Exclusion criteria: Participants with the presence of a herniated disc; history of sleepiness or persistent weakness in the legs or leg, or history of claudication; confirmed by neurological evaluation or imaging test; that they are subjected to previous surgery in the lombar spine, that present neurological and/or orthopedic alterations that make it impossible and/or limit the patient's movements; that present malignant tumor; inflammatory or infectious disease; metal implants in the head; with mark steps; individuals who do not meet our inclusion criteria and individuals who will not grant the free and informed consent term.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sample size calculation was based on ANOVA for 3 groups and data from the Straud S. et. al. 2018, considering a probability of type I error of 0.05, of type II error of 0.20 (80% power), and a minimum difference of two and a half points on the visual analogue scale, identified as the minimum clinically important difference ( van der Roer N. et. al. 2006). For these values, we obtained the n of 20 participants per group. The sample was increased by 20% to compensate for possible losses, leaving 24 individuals in each group (sample total of 72 participants). (Group 1: active tDCS + active BMT, Group 2: placebo tDCS + placebo BMT and Group 3: placebo tDCS + active BMT) By carrying out the study, it is expected to find a probable influence of osteopathic manipulative treatment (OMT) associated with transcranial direct current stimulation (tDCS) in increasing the pain threshold in participants with chronic low back pain of unspecific origin. The Visual Analogue Scale (VAS) for pain is a one-dimensional instrument for the assessment of pain intensity. This is a line with ends numbered 0-10. At one end of the line it is marked “no pain” and at the other end “worst pain imaginable”. The patient is then asked to assess and mark the pain present at that moment on the line. The VAS will be used and explained at the beginning and at the end of the service in both groups, recording the result always in the evolution. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Roland Morris Disability Questionnaire will be used to assess functional performance associated with low back pain, the questionnaire corresponds to an instrument translated and adapted for the Brazilian population and widely used in research and clinical practice to assess functional performance associated with low back pain. This questionnaire consists of 24 items that exemplify functional consequences resulting from low back pain. Through the study it is expected to find an improvement in functionality in patients with low back pain of nonspecific origin.;The EQ-5D questionnaire (EuroQol-5D), the measure of health-related quality of life, refers to the way an individual assesses his own general well-being and his health. It is a generic quality of life questionnaire covering 5 health domains (mobility, personal care, usual activities, pain / discomfort and anxiety / depression). Through the study it is expected to find an improvement in the quality of life in patients with low back pain of non-specific origin.;The Oswestry Disability Index questionnaire (also known as the Oswestry Low Back Pain Disability Questionnaire) is a disease-specific instrument for assessing the functionality of spinal disorders, where ten criteria are evaluated with six response alternatives. It is an extremely important tool that researchers and disability assessors use to measure a patient's permanent functional disability. Through the study it is expected to find an improvement in functionality in patients with low back pain of nonspecific origin.;The Bournemouth Questionnaire comprises seven questions capable of measuring multidimensional domains of health, such as pain, function, disability, psychological and social factors in patients with low back pain. Each question in the Bournemouth Questionnaire is scored using 0 to 10 points on the Rating Scale. Numerical, and the final score, obtained by adding the seven topics, ranging from 0 to 70. Higher scores reflect more pain | — |
Countries
Brazil
Contacts
Public ContactDanilo Armbrust
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Outcome results
None listed