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

University of Brasilia

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Other: Spinal manipulation/myofascial release; Other: Spinal manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03434990

ChiroRCT

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Spinal manipulation/myofascial release

Experimental group

Description:

2x/week, for 3 weeks, performed by a chiropractor. Sessions will last 20 minutes, with 1 individual per session. Myofascial release will be done on paravertebral muscle (Erector spinae, quadratus lumborum) and on gluteus maximus and piriform muscles, the pressure will depend of pain tolerance of each subject. After this procedure, the spinal manipulation will be performed on the sacroiliac join and on the lumbar vertebrae with less mobility.

Treatment:

Other: Spinal manipulation/myofascial release

Spinal manipulation

Active Comparator group

Description:

2x/week, for 3 weeks, performed by a chiropractor. Sessions will last 20 minutes, with 1 individual per session. The spinal manipulation will be performed on the sacroiliac join and on the lumbar vertebrae with less mobility.

Treatment:

Other: Spinal manipulation