Low Back PainNCT04716101
Ultrasound Imaging Measurements of the Thoracolumbar Fascia
A study testing Massage therapy technique in people with Low Back Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
In this prospective study, eligible subjects with chronic non specific low back pain and asymptomatic volunteers will undergo a research dynamic ultrasound exam of the lower back before and after a massage technique. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Massage therapy technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 26 Feb 2021to 31 Oct 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient group:
- Presenting with chronic low back and/or referred pain (non specific pattern) above or just below the gluteal fold of at least 3/10 on a numerical pain rating scale (NRS), for at least 6 months;
- Pain is present at least 50% of the time during the day;
- Asymptomatic group:
- No history of low back pain or any other chronic pain limiting activities of daily living or work.
Who cannot join
- History of back surgery;
- History of severe back or low extremity injury;
- Back pain attributable to a specific, recognizable, known pathology (i.e.: infection, tumor, fracture, spinal stenosis, sciatica etc.);
- Corticosteroid medication intake or corticosteroid injection in the lumbar spine in the previous 3 months;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
About this study
Official title: Ultrasound Imaging Measurements of the Thoracolumbar Fascia Following Massage Therapy: a Proof of Concept Study
In this prospective study, eligible subjects with chronic non specific low back pain and asymptomatic volunteers will undergo a research dynamic ultrasound exam of the lower back before and after a massage technique.
The overall aim of the present research is to develop ultrasonographic parameters that characterize the geometrical, the mechanical and tissue characteristic properties of the thoracolumbar fascia, and to explore the effect of a massage therapy technique on these parameters.
Read the detailed description
In this prospective proof of concept study, eligible subjects with chronic non specific low back pain and asymptomatic volunteers will undergo a research dynamic ultrasound (US) exam of the thoracolumbar fascia (TLF) of the lower back. A musculoskeletal radiologist will perform the US exams consisting of a series of 5 dynamic scans of both the right and left paraspinal muscles, obtained during 15 degrees of passive flexion of the lower body using a motorized table.
Following the US exam, the group of patients and the group of volunteers will be respectively randomized to receive either a standardized massage technique intervention or a sham technique. The US exam will be repeated after the intervention.
Ultrasound image segmentation will be performed by two independent observers and inter-rater variability will be assessed. Post-processing of the US recordings will include assessment of geometrical (thickness), mechanical (percent shear strain between the TLF and the epimysium-muscle complex) and tissue ultrastructure features (the mean intensity μ, the scatterer clustering parameter α and the structure parameter κ of the echo envelope). These features will be compared between patients and volunteers and between the intervention groups.
- Conditions
- Low Back Pain
- Being tested
- Massage therapy technique, Sham massage technique
- Keywords
- Fascia, Quantitative ultrasound, Elastography, Massage therapy
- 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.
Massage therapy techniqueOther
The massage therapy technique consists of manual deep and slow compression and shearing forces applied on the lumbar spine muscles and thoracolumbar fascia in a distal to proximal direction.
Sham massage techniqueOther
For the sham massage technique the massage therapist will put the right palm at the participant's right lower back along erector spinae and likewise left palm at left lower back without applying force, holding the palm during 2 minutes and half.
| Study group | Role | What they receive |
|---|---|---|
| Patients with nonspecific low back pain | Experimental | Patients will be randomized to receive either a massage technique or a sham massage technique. Receives: Other: Massage therapy technique; Other: Sham massage technique |
| Asymptomatic volunteers | Active comparator | Similarly, the volunteers will be randomized to receive either a massage technique or a sham massage technique. Receives: Other: Massage therapy technique; Other: Sham massage technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Shear Strain After the Massage Intervention
Percent shear strain between the thoracolumbar fascia and the epimysium of the erector spinae muscle.
Measured: Baseline and immediately after the massage intervention.
Secondary outcomes (4)
Thickness
Thickness (millimeters) of the thoracolumbar fascia.
Measured: Baseline
Change from Baseline Quantitative Ultrasound Marker 'μ' After the Massage Intervention.
Statistical analysis of the echo envelope: the mean intensity μ. This marker is unitless.
Measured: Baseline and immediately after the massage intervention.
Change from Baseline Quantitative Ultrasound Marker 'α' After the Massage Intervention.
Statistical analysis of the echo envelope: the scatterer clustering parameter α. This marker is unitless.
Measured: Baseline and immediately after the massage intervention.
Change from Baseline Quantitative Ultrasound Marker 'κ' After the Massage Intervention.
Statistical analysis of the echo envelope: the structure parameter κ. This marker is unitless.
Measured: Baseline and immediately after the massage intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start26 Feb 2021
- Primary completion22 Jun 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie J Bureau, MD MSc, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716101
- Sponsor's protocol ID
- CE 19.358
- Status last verified
- Feb 2025
- First submitted
- 14 Jan 2021
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tomita N, Roy-Cardinal MH, Chayer B, Daher S, Attiya A, Boulanger A, Gaudreault N, Cloutier G, Bureau NJ. Thoracolumbar fascia ultrasound shear strain differs between low back pain and asymptomatic individuals: expanding the evidence. Insights Imaging. 2025 Jan 15;16(1):18. doi: 10.1186/s13244-024-01895-2.
PubMed 39812963Tomita N, Destrempes F, Cardinal MR, Boulanger A, Gaudreault N, Cloutier G, Bureau NJ. Thoracolumbar Fascia Microstructure and Low Back Pain: Insights From Quantitative Ultrasound Homodyned K-Distribution Statistical Modeling. Ultrasound Med Biol. 2025 Nov;51(11):2113-2119. doi: 10.1016/j.ultrasmedbio.2025.07.031. Epub 2025 Aug 23.
PubMed 40850900
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Imaging Measurements of the Thoracolumbar Fascia Following Massage Therapy: a Proof of Concept Study
- ClinicalTrials.gov ID
- NCT04716101
- Acronym / sponsor ID
- CE 19.358
- Conditions
- Low Back Pain
- Keywords
- Fascia, Quantitative ultrasound, Elastography, Massage therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 20 Jan 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.
In this prospective study, eligible subjects with chronic non specific low back pain and asymptomatic volunteers will undergo a research dynamic ultrasound exam of the lower back before and after a massage technique.
The overall aim of the present research is to develop ultrasonographic parameters that characterize the geometrical, the mechanical and tissue characteristic properties of the thoracolumbar fascia, and to explore the effect of a massage therapy technique on these parameters.
Detailed description
In this prospective proof of concept study, eligible subjects with chronic non specific low back pain and asymptomatic volunteers will undergo a research dynamic ultrasound (US) exam of the thoracolumbar fascia (TLF) of the lower back. A musculoskeletal radiologist will perform the US exams consisting of a series of 5 dynamic scans of both the right and left paraspinal muscles, obtained during 15 degrees of passive flexion of the lower body using a motorized table.
Following the US exam, the group of patients and the group of volunteers will be respectively randomized to receive either a standardized massage technique intervention or a sham technique. The US exam will be repeated after the intervention.
Ultrasound image segmentation will be performed by two independent observers and inter-rater variability will be assessed. Post-processing of the US recordings will include assessment of geometrical (thickness), mechanical (percent shear strain between the TLF and the epimysium-muscle complex) and tissue ultrastructure features (the mean intensity μ, the scatterer clustering parameter α and the structure parameter κ of the echo envelope). These features will be compared between patients and volunteers and between the intervention groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with nonspecific low back pain | Experimental | Other: Massage therapy technique, Other: Sham massage techniquePatients will be randomized to receive either a massage technique or a sham massage technique. |
| Asymptomatic volunteers | Active comparator | Other: Massage therapy technique, Other: Sham massage techniqueSimilarly, the volunteers will be randomized to receive either a massage technique or a sham massage technique. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presenting with chronic low back and/or referred pain (non specific pattern) above or just below the gluteal fold of at least 3/10 on a numerical pain rating scale (NRS), for at least 6 months;
- Pain is present at least 50% of the time during the day;
- No history of low back pain or any other chronic pain limiting activities of daily living or work.
Key exclusion criteria (5 listed)
- History of back surgery;
- History of severe back or low extremity injury;
- Back pain attributable to a specific, recognizable, known pathology (i.e.: infection, tumor, fracture, spinal stenosis, sciatica etc.);
- Corticosteroid medication intake or corticosteroid injection in the lumbar spine in the previous 3 months;
- Pregnancy.
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 |
|---|---|---|
| Massage therapy techniqueThe massage therapy technique consists of manual deep and slow compression and shearing forces applied on the lumbar spine muscles and thoracolumbar fascia in a distal to proximal direction. | Other | Asymptomatic volunteers, Patients with nonspecific low back pain |
| Sham massage techniqueFor the sham massage technique the massage therapist will put the right palm at the participant's right lower back along erector spinae and likewise left palm at left lower back without applying force, holding the palm during 2 minutes and half. | Other | Asymptomatic volunteers, Patients with nonspecific low back pain |
Primary outcome
Change from Baseline Shear Strain After the Massage Intervention
Time frame: Baseline and immediately after the massage intervention.
Percent shear strain between the thoracolumbar fascia and the epimysium of the erector spinae muscle.
4 secondary outcomes
Thickness
Time frame: Baseline
Change from Baseline Quantitative Ultrasound Marker 'μ' After the Massage Intervention.
Time frame: Baseline and immediately after the massage intervention.
Change from Baseline Quantitative Ultrasound Marker 'α' After the Massage Intervention.
Time frame: Baseline and immediately after the massage intervention.
Change from Baseline Quantitative Ultrasound Marker 'κ' After the Massage Intervention.
Time frame: Baseline and immediately after the massage 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 25 Feb 2025.
- Results publication: PubMed 39812963Tomita N, Roy-Cardinal MH, Chayer B, Daher S, Attiya A, Boulanger A, Gaudreault N, Cloutier G, Bureau NJ. Thoracolumbar fascia ultrasound shear strain differs between low back pain and asymptomatic individuals: expanding the evidence. Insights Imaging. 2025 Jan 15;16(1):18. doi: 10.1186/s13244-024-01895-2.
- Derived from this study: PubMed 40850900Tomita N, Destrempes F, Cardinal MR, Boulanger A, Gaudreault N, Cloutier G, Bureau NJ. Thoracolumbar Fascia Microstructure and Low Back Pain: Insights From Quantitative Ultrasound Homodyned K-Distribution Statistical Modeling. Ultrasound Med Biol. 2025 Nov;51(11):2113-2119. doi: 10.1016/j.ultrasmedbio.2025.07.031. Epub 2025 Aug 23.
- Individual participant dataSharing planned: No
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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.
Nathalie J Bureau, MD MSc principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage therapy technique in people with Low Back Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 5 inclusion and 5 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 25 Feb 2025. 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. 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?
Change from Baseline Shear Strain After the Massage Intervention (time frame: Baseline and immediately after the massage intervention.). 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 NCT04716101, which also lists 2 linked publications.
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 25 Feb 2025.