Clinical trial NCT03434990: Effects of the Spinal Manipulative Therapy and Myofascial Release in Individuals With Non-specific Chronic Low Back Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: spinal manipulative therapy
Myofascial release
Low back pain
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity
timeFrame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
measure: Disability
timeFrame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Secondary outcomes:
measure: Muscle fatigue
timeFrame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
measure: Health Status
timeFrame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
measure: Balance
timeFrame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
measure: Perception of Recovery
timeFrame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
measure: Pain threshold
timeFrame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Complexo da Academia do Bombeiro Militar DF
state: DF
Study officials:
affiliation: University of Brasilia
name: Rodrigo Carregaro, PhD
role: PRINCIPAL_INVESTIGATOR
References: