Chronic Low Back PainChiroRCTNCT03434990

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

A study testing Spinal manipulation/myofascial release and Spinal manipulation in people with Chronic Low Back Pain, run by University of Brasilia at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Chronic Low Back Pain
What is being tested?: Spinal manipulation/myofascial release and Spinal manipulation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteBrazil
Study dates: 8 Feb 2018to 17 Sep 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

Brazil1 site

Complexo da Academia do Bombeiro Militar DF
Brasília, Federal District, 70602-900

Other trials in Brazil

About this study

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

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
Being tested: Spinal manipulation/myofascial release, Spinal manipulation
Keywords: spinal manipulative therapy, Myofascial release, Low back pain
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spinal manipulation/myofascial releaseOther
Also called Manual therapy
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 manipulationOther
Also called Manual therapy
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.

Study groups in NCT03434990
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Spinal manipulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain intensity
Pain intensity measured by a Visual Analog Scale (in centimeters)
Measured: 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)
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

Secondary outcomes (5)

Muscle fatigue
Muscle fatigue measured by the Biering-Sorensen test (in seconds)
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Health Status
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
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Balance
Y-Balance test (in cm)
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Perception of Recovery
Perception of Recovery measured by a Likert scale (6-points)
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Pain threshold
Pain threshold measured by Algometry (in kgf)
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 201817 Sep 2018

First posted15 Feb 2018
Study start8 Feb 2018
Primary completion17 Sep 2018
Study completion17 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03434990
Sponsor's protocol ID: ChiroRCT
Acronym: ChiroRCT
Status last verified: Nov 2018
First submitted: 8 Feb 2018
Last updated: 27 Nov 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03434990
Acronym / sponsor ID: ChiroRCT / ChiroRCT
Conditions: Chronic Low Back Pain
Keywords: spinal manipulative therapy, Myofascial release, Low back pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: University of BrasiliaUniversity, hospital or other
Study start: 8 Feb 2018 (actual)
Primary completion: 17 Sep 2018 (actual)
Study completion: 17 Sep 2018 (actual)
First posted: 15 Feb 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Spinal manipulation/myofascial release	Experimental	Other: Spinal manipulation/myofascial release2x/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.
Spinal manipulation	Active comparator	Other: Spinal manipulation2x/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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Spinal manipulation/myofascial releaseAlso: Manual therapyThe 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	Spinal manipulation/myofascial release
Spinal manipulationAlso: Manual therapyThe 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	Spinal manipulation

Primary outcome

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)
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)

5 secondary outcomes

Muscle fatigue
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Health Status
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Balance
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Perception of Recovery
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Pain threshold
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
Individual participant dataSharing planned: Undecided

Related trials for Chronic Low Back Pain

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rodrigo Carregaro, PhD principal investigator

University of Brasilia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Spinal manipulation/myofascial release and Spinal manipulation in people with Chronic Low Back Pain, run by University of Brasilia at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity (time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03434990.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.