- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03434990
Effects of the Spinal Manipulative Therapy and Myofascial Release in Individuals With Non-specific Chronic Low Back Pain (ChiroRCT)
November 24, 2018 updated by: Prof. Rodrigo Luiz Carregaro, University of Brasilia
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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DF
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Brasília, DF, Brazil, 70602-900
- Complexo da Academia do Bombeiro Militar DF
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
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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 Names:
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
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Pain intensity measured by a Visual Analog Scale (in centimeters)
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Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
|
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)
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Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
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Health Status
Time Frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
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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
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Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
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Balance
Time Frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
|
Y-Balance test (in cm)
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Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
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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)
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Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
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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)
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Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rodrigo Carregaro, PhD, University of Brasilia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 8, 2018
Primary Completion (ACTUAL)
September 17, 2018
Study Completion (ACTUAL)
September 17, 2018
Study Registration Dates
First Submitted
February 8, 2018
First Submitted That Met QC Criteria
February 14, 2018
First Posted (ACTUAL)
February 15, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 27, 2018
Last Update Submitted That Met QC Criteria
November 24, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChiroRCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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