NCT03434990: ChiroRCT

Effects of the Spinal Manipulative Therapy and Myofascial Release in Individuals With Non-specific Chronic Low Back Pain

Completed NA Last updated 27 November 2018

What this trial tests

NA trial testing Spinal manipulation/myofascial release in Chronic Low Back Pain in 90 participants. Completed in 17 September 2018.

Timeline

8 February 2018

Primary endpoint
17 September 2018

17 September 2018

Quick facts

Lead sponsor	University of Brasilia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	90
Start date	8 February 2018
Primary completion	17 September 2018
Estimated completion	17 September 2018
Sites	1 location across Brazil

Drugs / interventions tested

• Spinal manipulation/myofascial release
• Spinal manipulation

Conditions studied

• Chronic Low Back Pain — all drugs for Chronic Low Back Pain →

Sponsor

University of Brasilia

Who can join

Adults 18 to 60, any sex, with Chronic Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.