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

NCT ID: NCT03434990

Last Updated: 2018-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-08
• Study Completion Date: 2018-09-17

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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Spinal manipulation/myofascial release

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.

Group Type: EXPERIMENTAL

Spinal manipulation/myofascial release

Intervention Type: OTHER

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.

Spinal manipulation

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.

Group Type: ACTIVE_COMPARATOR

Spinal manipulation

Intervention Type: OTHER

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.

Interventions

Spinal 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.

Intervention Type: OTHER

Spinal 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.

Intervention Type: OTHER

Other Intervention Names

Manual therapy; Manual therapy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Brasilia

OTHER

Sponsor Role: lead

Responsible Party

Prof. Rodrigo Luiz Carregaro

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodrigo Carregaro, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Brasilia

Locations

Complexo da Academia do Bombeiro Militar DF

Brasília, Federal District, Brazil

Countries

Brazil

Other Identifiers

ChiroRCT

Identifier Type: -

Identifier Source: org_study_id