Chronic Low Back Pain
Conditions
Keywords
spinal manipulative therapy, Myofascial release, Low back pain
Brief 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.
Interventions
OTHERSpinal manipulation/myofascial release
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.
OTHERSpinal manipulation
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.
Sponsors
University of Brasilia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor won't have any knowledge about the study purposes and will be unaware of the group allocation. The statistical analysis will also be performed blinded for group allocation.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* presence of non-specific chronic low back pain for more than 12 consecutive weeks; * have not performed Physical Therapy, Osteopathic and/or chiropractic sessions for at least 3 months prior to the research.
Exclusion criteria
* history of trauma or fractures in the trunk and lumbar spine; * presence of neural root symptoms; * infection and inflammation on spine and upper and lower limbs for at least 3 months prior to research; * have undergone surgery on spine, chest and abdomen; * rheumatologic and myopathic diseases; * renal, digestion and neurological diseases; * use of anti-inflammatories drugs and analgesic drugs for at least 2 weeks prior the research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 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) |
| Disability | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balance | Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months) | Y-Balance test (in cm) |
| Muscle fatigue | 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) |
| Pain threshold | Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months) | Pain threshold measured by Algometry (in kgf) |
| Perception of Recovery | 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) |
| Health Status | 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 |
Countries
Brazil
Outcome results
None listed