Effects of Manipulative Therapy and Pain Education in Individuals With CLBP
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The burden of low back pain more than doubled in the last 20 years, probably caused by
      biopsychosocial factors. Some noninvasive treatments have been applied in individuals with
      chronic nonspecific low back pain as spinal manipulation and pain education. However, it is
      not already clear the neurophysiological effects of these treatments.The purpose of this
      research is to verify the effects of the technique of spinal manipulation and pain education
      in individuals with chronic low back pain
    

Detailed description: 
      The outcomes will be subjective pain (measured by Numeric Pain Rating Scale), pressure pain
      threshold (measured by Algometer), disability (measured by Roland-Morris Disability
      Questionnaire), fear and avoidance beliefs (measured by Fear Avoidance Beliefs
      Questionnaire), risk of poor prognosis (measured by STarT Back Screening Tool), quality of
      life (measured by Short Form-12v2) and blood biomarkers (measured by ELISA). The data will be
      collected by a blinded assessor.

      Individuals eligibility is going to be assessed by blinded assessor to determine if they are
      or not eligible for this research. Then, they will be informed about the objectives of this
      study and asked to sign the consent form. Afterward, the sociodemographic data will be
      recorded. The data related to the research outcomes will be collected by the blinded assessor
      at baseline assessment, after six weeks and three months.

      Random Allocation Before the treatment begins, one of the researchers not involved in the
      recruiting and assessment will allocate the individuals in one of the groups. Block
      randomization will be used; it is going to generate by randomization.com, this site will
      create a list with the randomization sequence, which will be only seen by the physical
      therapists that will treat the individuals.

      Statistical Methods

      Sample size calculation The sample size calculation was calculated with the A-priori test
      with the following specifications: Statistical test ANCOVA, the effect size of 0.25, the
      statistical power of 80%, and an alpha level of 5%. As a result, the study requires a sample
      size of 64 per group or 128 individuals in total.

      Analysis of effects of treatment Our research will use the intention-to-treat principles. The
      descriptive data and the scores of RMDQ, SBST, FABQ, SF-12v2 and NPRS as well as the pressure
      pain threshold means and the values of inflammatory biomarkers, before and after
      interventions, will be tabbed on Microsoft Excel 2010. To see the effect of treatment is
      going to be used statistical based on intention-to-treat principles, statistical analyses
      will be used to analyses data of individuals socio-demographics and clinics characteristics,
      and they will be presented by mean and standard deviation. To compare the groups,
      Shapiro-Wilk test will be applied to test the normality distribution of data, depending on
      this distribution will be used ANOVA one-way for parametric data or Kruskal-Wallis test for
      non-parametric data. To compare groups on the pre-intervention period another ANOVA-one way
      or another Kruskal-Wallis will be applied.

      Covariance analysis (ANCOVA) will be conducted to assess the effect of treatment on the
      following outcomes: Scores obtained on RMDQ, FABQ, SF-12v2, SBST and NPRS, pressure pain
      threshold and the blood biomarkers concentrations, utilizing the post-treatment means as
      dependent variables, the pre-treatment means as co-variables and the group as fixed factor.

      To the relationships among the variables must be applied the Pearson correlation coefficient
      to parametric data and Spearman correlation coefficient to nonparametric data. To classify
      the relationships will be used the Munro's classification, where values between 0.26 and 0.49
      will be low, values between 0.50 and 0.69 will be moderate, between 0.70 and 0.89 will be
      high values, and between 0.90 and 1.0 will be considered very high. For all of these analyses
      will be used the Statistical Package for the Social Sciences (IBM SPSS version 20.0, IBM
      Corp, Armonk, New York).
    

Intervention name(s): Manipulative Therapy; Pain Education; Sham
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects will receive techniques of High Velocity and Low Amplitude (HVLA) or grade V manipulation to the lumbar region (lumbar roll), and pain education based on the biopsychosocial approach.; Individuals will receive pain education based in a biopsychosocial approach; The individuals will receive a simulation of spinal manipulation (sham) involving manual contact over lumbar region totaling 5 minutes.
Other intervention name(s): Manual Therapy; Grade V Manipulation; Spinal Manipulation; Neuroscience Pain Education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low Back Pain; Musculoskeletal Manipulations; Neurophysiology; Education