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

NCT03434990 | Completed

• 1 other identifier: ChiroRCT
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

spinal manipulative therapy; Myofascial release; Low back pain

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Pain intensity measured by a Visual Analog Scale (in centimeters)

  Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

• Disability

  Quebec Back Pain Disability Scale (scores ranging from 0 to 100)

  Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

Secondary Outcomes (5)

• Muscle fatigue

  Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

• Health Status

  Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

• Balance

  Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

• Perception of Recovery

  Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

• Pain threshold

  Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

Study Arms (2)

Spinal manipulation/myofascial release

EXPERIMENTAL

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.

Other: Spinal manipulation/myofascial release

Spinal manipulation

ACTIVE COMPARATOR

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.

Other: Spinal manipulation

Interventions

Spinal manipulation/myofascial release 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.

Also known as: Manual therapy

Spinal manipulation/myofascial release

Spinal manipulation 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.

Also known as: Manual therapy

Spinal manipulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Brasilia: lead

Study Sites (1)

Complexo da Academia do Bombeiro Militar DF

Brasília, Federal District, 70602-900, Brazil

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Spinal; Myofascial Release Therapy; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation; Massage; Therapy, Soft Tissue; Complementary Therapies

Study Officials

• Rodrigo Carregaro, PhD

  University of Brasilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 15, 2018
• Study Start: February 8, 2018
• Primary Completion: September 17, 2018
• Study Completion: September 17, 2018
• Last Updated: November 27, 2018

Record last verified: 2018-11

Locations

BR (1)