Complexo da Academia do Bombeiro Militar DF
Brasília, Federal District, 70602-900, Brazil
NCT Number: NCT03434990
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Brasília, Federal District, 70602-900, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Manual therapy
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 names: Manual therapy
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Pain intensity measured by a Visual Analog Scale (in centimeters)
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Quebec Back Pain Disability Scale (scores ranging from 0 to 100)
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Muscle fatigue measured by the Biering-Sorensen test (in seconds)
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Health Status measured by the EQ-5D-3L questionnaire, consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The responses record three levels of severity
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Y-Balance test (in cm)
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Perception of Recovery measured by a Likert scale (6-points)
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Pain threshold measured by Algometry (in kgf)
University of Brasilia
Other
Effects of the Spinal Manipulative Therapy and Myofascial Release on Pain Threshold, Muscle Function and Balance of Individuals With Non-specific Chronic Low Back Pain: Randomized Controlled Trial
Acronym: ChiroRCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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