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

• ClinicalTrials.gov Identifier: NCT03434990
• Recruitment Status: Completed
• First Posted: February 15, 2018
• Last Update Posted: November 27, 2018
• Sponsor: University of Brasilia
• Information provided by (Responsible Party): Prof. Rodrigo Luiz Carregaro, University of Brasilia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Low Back Pain	Other: Spinal manipulation/myofascial release; Other: Spinal manipulation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Single (Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 8, 2018
• Actual Primary Completion Date: September 17, 2018
• Actual Study Completion Date: September 17, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: 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.; Other Name: Manual therapy
Active Comparator: 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.	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.; Other Name: Manual therapy

Outcome Measures

Primary Outcome Measures :

1. Pain intensity [ Time Frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months) ]
   Pain intensity measured by a Visual Analog Scale (in centimeters)
2. Disability [ Time Frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months) ]
   Quebec Back Pain Disability Scale (scores ranging from 0 to 100)

Secondary Outcome Measures :

1. Muscle fatigue [ Time Frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months) ]
   Muscle fatigue measured by the Biering-Sorensen test (in seconds)
2. Health Status [ Time Frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months) ]
   Health Status measured by the EQ-5D-3L questionnaire, consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The responses record three levels of severity
3. Balance [ Time Frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months) ]
   Y-Balance test (in cm)
4. Perception of Recovery [ Time Frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months) ]
   Perception of Recovery measured by a Likert scale (6-points)
5. Pain threshold [ Time Frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months) ]
   Pain threshold measured by Algometry (in kgf)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Brazil

Complexo da Academia do Bombeiro Militar DF

Brasília, DF, Brazil, 70602-900

Sponsors and Collaborators

University of Brasilia

Investigators

• Principal Investigator: Rodrigo Carregaro, PhD; University of Brasilia

More Information

• Responsible Party: Prof. Rodrigo Luiz Carregaro, Prof. Dr., University of Brasilia
• ClinicalTrials.gov Identifier: NCT03434990
• Other Study ID Numbers: ChiroRCT
• First Posted: February 15, 2018
• Last Update Posted: November 27, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Rodrigo Luiz Carregaro, University of Brasilia:

spinal manipulative therapy; Myofascial release; Low back pain

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations