Chronic Low Back PainNCT04830566
Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Myofascia of Chronic Low Back Pain Adults
A study testing Myofascial release technique and Simulated Myofascial Release technique in people with Chronic Low Back Pain, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Non-specific low back pain is a worldwide health issue that remains poorly understood. Some authors have shown that the thoracolumbar fascia of low back pain adults presents changes in biomechanical properties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Myofascial release technique and Simulated Myofascial Release technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- 19 Mar 2021to 15 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults over 18 years of age,
- lumbar pain and/or referred pain above or below the gluteal fold , with intensity > 3/10, persisting for > 6 months and presenting during the day > 50% of the time.
Who cannot join
- history of serious spinal or lower extremity injury or surgery in the last year
- identifiable back pain or known pathology
- known rheumatological condition
- oral or injectable corticosteroids in the lumbar spine within the last 3 months
- psychiatric disorder
- pregnancy
- manual treatment of the lumbo-sacral region 1 month prior to the experimentation and during the week of the study
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Paraspinal Muscle and Thoracolumbar Fascia in Chronic Low Back Pain Adults Assessed by Elastography, Ultrasonography and Myometry
Non-specific low back pain is a worldwide health issue that remains poorly understood. Some authors have shown that the thoracolumbar fascia of low back pain adults presents changes in biomechanical properties. As it is richly endowed with pain receptors, the thoracolumbar fascia could therefore be a key contributor to this chronic pain condition. Myofascial techniques (MFTs) are commonly used in manual therapy by practitioners of various backgrounds to address fascia biomechanical properties, but there is a paucity of objective evidence on their effects on tissue state. Musculoskeletal ultrasonography, sonoelastography and myometry are emerging imaging techniques that can quantify the biomechanical properties of fascia and underlying muscle. These innovative techniques could in turn contribute to a better understanding of MFTs effects on fascial properties.
The main objective of this study is to evaluate the immediate effect of a standardized MFT on the elastography features of the lumbar paraspinal muscle and fascia (i.e. myofascial unit). The secondary objectives are to evaluate the immediate effects of a MFT on: i) ultrasonography features of the myofascial unit; ii) myometry features of the myofascial unit; ii) pain intensity.
- Conditions
- Chronic Low Back Pain
- Being tested
- Myofascial release technique, Simulated Myofascial Release technique
- Keywords
- Low back pain, Fascia properties, Thoracolumbar fascia, Myofascial release, Manual therapy, Osteopathy, Ultrasound imaging, Sonoelastography
- 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.
Myofascial release techniqueOther
Myofascial technique on the thoracolumbar fascia and lumbar paraspinal muscles
Simulated Myofascial Release techniqueOther
Superficial hands contact on the lumbar area
| Study group | Role | What they receive |
|---|---|---|
| Myofascial release technique group | Experimental | Not described Receives: Other: Myofascial release technique |
| Simulated myofascial release technique group | Sham comparator | Not described Receives: Other: Simulated Myofascial Release technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in elastography features of the myofascial unit
Evaluated with a shear wave sonoelastography device.
Measured: Baseline (before treatment), post-treatment (immediately after treatment)
Secondary outcomes (3)
Changes in ultrasonography features of the myofascial unit
Evaluated with a B-mode ultrasound imaging device
Measured: Baseline (before treatment) post-treatment (immediately after treatment)
Changes in myometry features of the myofascial unit
Evaluated with a myotonometer
Measured: Baseline (before treatment) post-treatment (immediately after treatment)
Changes in pain intensity
Numeric rating Scale (0 to 10; minimum = 0; maximum = 10; higher score means worst outcome)
Measured: Baseline (before treatment) post-treatment (immediately after treatment), at day 2 and at day 7 after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start19 Mar 2021
- Primary completion8 Jul 2022
- Study completion15 Jul 2022
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.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mélanie Morin, Université de Sherbrooke
- Investigators
- Nathaly Gaudreault, PhD, Study director, Université de SherbrookeMélanie Morin, PhD, Study director, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830566
- Sponsor's protocol ID
- 2021-3572
- Status last verified
- Oct 2022
- First submitted
- 19 Mar 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Paraspinal Muscle and Thoracolumbar Fascia in Chronic Low Back Pain Adults Assessed by Elastography, Ultrasonography and Myometry
- ClinicalTrials.gov ID
- NCT04830566
- Acronym / sponsor ID
- 2021-3572
- Conditions
- Chronic Low Back Pain
- Keywords
- Low back pain, Fascia properties, Thoracolumbar fascia, Myofascial release, Manual therapy, Osteopathy, Ultrasound imaging, Sonoelastography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 5 Apr 2021 (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.
Non-specific low back pain is a worldwide health issue that remains poorly understood. Some authors have shown that the thoracolumbar fascia of low back pain adults presents changes in biomechanical properties. As it is richly endowed with pain receptors, the thoracolumbar fascia could therefore be a key contributor to this chronic pain condition. Myofascial techniques (MFTs) are commonly used in manual therapy by practitioners of various backgrounds to address fascia biomechanical properties, but there is a paucity of objective evidence on their effects on tissue state. Musculoskeletal ultrasonography, sonoelastography and myometry are emerging imaging techniques that can quantify the biomechanical properties of fascia and underlying muscle. These innovative techniques could in turn contribute to a better understanding of MFTs effects on fascial properties.
The main objective of this study is to evaluate the immediate effect of a standardized MFT on the elastography features of the lumbar paraspinal muscle and fascia (i.e. myofascial unit). The secondary objectives are to evaluate the immediate effects of a MFT on: i) ultrasonography features of the myofascial unit; ii) myometry features of the myofascial unit; ii) pain intensity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofascial release technique group | Experimental | Other: Myofascial release technique |
| Simulated myofascial release technique group | Sham comparator | Other: Simulated Myofascial Release technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults over 18 years of age,
- lumbar pain and/or referred pain above or below the gluteal fold , with intensity > 3/10, persisting for > 6 months and presenting during the day > 50% of the time.
Key exclusion criteria (7 listed)
- history of serious spinal or lower extremity injury or surgery in the last year
- identifiable back pain or known pathology
- known rheumatological condition
- oral or injectable corticosteroids in the lumbar spine within the last 3 months
- psychiatric disorder
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 |
|---|---|---|
| Myofascial release techniqueMyofascial technique on the thoracolumbar fascia and lumbar paraspinal muscles | Other | Myofascial release technique group |
| Simulated Myofascial Release techniqueSuperficial hands contact on the lumbar area | Other | Simulated myofascial release technique group |
Primary outcome
Changes in elastography features of the myofascial unit
Time frame: Baseline (before treatment), post-treatment (immediately after treatment)
Evaluated with a shear wave sonoelastography device.
3 secondary outcomes
Changes in ultrasonography features of the myofascial unit
Time frame: Baseline (before treatment) post-treatment (immediately after treatment)
Changes in myometry features of the myofascial unit
Time frame: Baseline (before treatment) post-treatment (immediately after treatment)
Changes in pain intensity
Time frame: Baseline (before treatment) post-treatment (immediately after treatment), at day 2 and at day 7 after the intervention
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 2 Nov 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Low Back Pain
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Chronic Non Specific Mechanical Low Back Pain
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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.
Nathaly Gaudreault, PhD study director
Université de Sherbrooke
Mélanie Morin, PhD study director
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial release technique and Simulated Myofascial Release technique in people with Chronic Low Back Pain, run by Université de Sherbrooke at 1 site in Canada.
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 2 Nov 2022. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Changes in elastography features of the myofascial unit (time frame: Baseline (before treatment), post-treatment (immediately after treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2022.