Effects of the Spinal Manipulative Therapy and Myofascial Release in Individuals With Non-specific Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The aim will be to compare a experimental group submitted to a protocol of spinal
      manipulation and myofascial release; and a control group composed by spinal manipulation
      only, in individuals with chronic non-specific low back pain. This is a randomized controlled
      trial, characterized by the application of manual therapy, in two modalities: spinal
      manipulation plus myofascial release and spinal manipulation alone. Participants will be
      enrolled and randomly allocated into two groups: 1) spinal manipulation plus myofascial
      release, totaling 6 sessions, 2x/week, for 3 weeks; 2) spinal manipulation: 6 sessions,
      2x/week, for 3 weeks. Participants will be evaluated in two different moments: 1) Baseline
      (pre-intervention); 2) at the end of intervention period (3 weeks); and 3) after 3 months
      follow-up. The primary outcomes will be pain intensity (measured in centimeters with the
      visual analogue scale - VAS) and disability (measured by the Quebec questionnaire - QDS). The
      secondary outcomes will be muscle fatigue (measured by the Biering-Sorensen test), postural
      balance (measured by the Y Balance test), pain threshold (algometry, in kgf) and perception
      of recovery (Likert scale of 6-points) and health status (measured by the Eq5d3L
      questionnaire). Data analysis will be performed with the SPSS (Statistical Package for the
      Social Sciences) software version 24.0. Data normality assumptions will be confirmed by the
      Shapiro Wilk test. If the assumptions were met, a mixed ANOVA with repeated measures will be
      adopted, based on the outcomes and the independent variables (groups), for the comparison
      between pre-intervention and post-intervention. Spinal manipulation plus myofascial release
      is expected to have better effects than spinal manipulation alone, associated with the
      outcomes of interest.
    


Intervention name(s): Spinal manipulation/myofascial release; Spinal manipulation
Intervention type(s): Other; Other
Intervention description(s): The protocol will be composed by myofascial release followed by spinal manipulation. Paravertebral muscles and gluteus maximus and piriform muscles will be manually checked for tension, stiffness, spasm and painful points. The intervention will be composed by: trigger points release, release of muscle fascia and active release technique. The myofacial release will be done with a constant pressure during 30 seconds, 3x in each point. After this procedure, the spinal manipulation will be performed in high velocity and low amplitude thrust technique, on the lumbar spine and sacroiliac joint.; The sacroiliac joint will be test and manually verified for any dysfunction, and the lumbar spine will be also assessed to verify any hypomobility and vertebral rotation. The segments with alterations will be manipulated with a high velocity and low amplitude thrust technique.
Other intervention name(s): Manual therapy; Manual therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized controlled trial, characterized by the application of manual therapy, in which subjects will be randomly allocated into two groups: spinal manipulation plus myofascial release and spinal manipulation. The participants will be individuals with non-specific chronic low back pain. The study will be reported following the recommendations of the CONSORT Statement. For the present study, non-specific chronic low back pain was defined as uninterrupted low back pain for more than 12 weeks, with unknown causes.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: spinal manipulative therapy; Myofascial release; Low back pain