Low Back PainNCT04843800
Ultrasound of the Thoracolumbar Fascia for Diagnosing Chronic Low Back Pain
A study testing Manual therapy in people with Low Back Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
It is estimated that 23% of Quebecers suffer from chronic low back pain, and that 12% are disabled by this condition. Despite medical advances, the origin of so-called 'nonspecific low back pain' remains enigmatic. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Manual therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2022to 24 Jul 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ongoing 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 3 months;
- Pain has resulted in a problem on at least 50% of the days in the past 6 months;
- Only use of oral non-steroidal anti-inflammatory drugs for pain treatment in the 4 weeks before treatment;
- Willingness to commit to treatment sessions (acupuncture, chiropractic therapy or therapeutic massage) and to follow-up visits.
Who cannot join
- Back pain attributable to a specific, recognizable, known pathology:
- protrusion or prolapse of 1 or more intervertebral discs with concurrent neurological symptoms;
- radicular pain (sciatica);
- infectious spondylopathy;
- low back pain caused by inflammatory, malignant, or autoimmune disease;
- congenital deformation of the spine (except for slight lordosis or scoliosis);
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- compression fracture caused by osteoporosis;
- spinal stenosis;
- spondylolysis or spondylolisthesis;
- Pregnancy;
- History of spinal surgery;
- History of pelvis or hip fractures;
- Acupuncture, spinal manipulation or therapeutic massage for back pain within the past year;
- Severe clotting disorders or anticoagulant therapy;
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: Imaging Pain! Ultrasound-based Palpation and Visualization for Diagnosing Chronic Low Back Pain
It is estimated that 23% of Quebecers suffer from chronic low back pain, and that 12% are disabled by this condition. Despite medical advances, the origin of so-called 'nonspecific low back pain' remains enigmatic. Conventional imaging methods by computed tomography and magnetic resonance may provide information on vertebral structures. However, very often, they do not diagnose lesions that genuinely correlate with the patient's symptoms. The lack of accurate diagnosis limits the therapeutic management in these patients.
Therefore, patients are increasingly turning to alternative and complementary medicine therapies (e.g., acupuncture, chiropractic , osteopathy, shiatsu) to relieve their pain. These therapies target painful areas of abnormal hardening in muscles of the lower back and aim to release the tension in these tissues to control pain. However, these painful areas and their resolution after manual therapy have yet to be demonstrated by means other than manual palpation. We will conduct a randomized controlled trial in chronic low back pain patients to examine the effects of acupuncture, chiropractic therapy and therapeutic massage on lower back muscular and connective tissues' physical properties using innovative ultrasound techniques.
Read the detailed description
This will be a phase II, prospective, randomized controlled study, which will have received IRB approval and will be registered at Clinicaltrials.gov before it begins. Participants with chronic non specific low back pain (NSLBP) will be recruited from one site. On the day of the registration visit, the participants will meet with the research assistant to review and sign the consent form, give clinical and demographic data and respond to validated outcome questionnaires.
The participants will then undergo a research dynamic ultrasound (US) of the lower back. One 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 passive flexion of the lower body. Following the US exam, the participants will be randomized in three groups (allocation 1:1). One group will receive a standardized acupuncture treatment and another group will receive a standardized chiropractic treatment. One treatment session per week for 3 consecutive weeks will be provided. Following the 3 treatment sessions, at week 4, the US exam will be repeated and the questionnaires will be administered.
The third group will be placed on a waiting list for 3 weeks and will be reexamined by US and respond to the questionnaires at week 4. Then, the participants will undergo a standardized therapeutic massage treatment with one treatment session per week for 3 consecutive weeks. Following the 3 treatment sessions, at week 7, the US exam will be repeated and the questionnaires will be administered.
- Conditions
- Low Back Pain
- Being tested
- Manual therapy
- Keywords
- Ultrasound imaging, Elastography, Lumbar fascia, Acupuncture therapy, Manipulation, Chiropractic, 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.
Manual therapyProcedure or surgery
Acupuncture, Chiropractic are recognized complementary medicines and Therapeutic Massage is an alternative healing practice.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | The acupuncture treatments will consist of one 45-minute session weekly, for 3 consecutive weeks. The acupuncture treatment protocol will be semi standardized according to usual practice. All patients will be treated with a selection of local and distant points, comprising 10 minutes of insertion time, 30 minutes of needle retention and manipulation to achieve de qi (an irradiating feeling) if possible. Receives: Procedure: Manual therapy |
| Chiropractic | Experimental | The chiropractic treatments will consist of one 20-minute session weekly, for 3 consecutive weeks. The Diversified technique is one of the most commonly practiced techniques by chiropractors. In the treatment of low back pain, this technique involves the application of a quick (high-velocity), short (low-amplitude) thrust (adjustment) to the lumbo-pelvic area. Receives: Procedure: Manual therapy |
| Waiting list and Therapeutic Massage | Experimental | The therapeutic massage treatments will consist of one 45-minute session weekly, for 3 consecutive weeks. A technique called Fascial Release will be used. Tension related to back pain is believed to be present not only in the back but also in various parts of the body such as the legs, through the connection of fascia, the membrane that surrounds the muscles. The purpose of this treatment is to reduce the tension connected to the lower back. Receives: Procedure: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
% shear strain change.
Percent shear strain between the thoracolumbar fascia and the epimysium of the erector spinae muscle.
Measured: Change from baseline % shear strain at week 4 (Groups 1, 2 and 3). Change from week-4 % shear strain at week 7 (Group 3).
Secondary outcomes (7)
Quantitative ultrasound marker 'μ' change.
Statistical analysis of the echo envelope: the mean intensity μ. This marker is unitless.
Measured: Change from baseline marker 'μ' at week 4 (Groups 1, 2 and 3). Change from week-4 marker 'μ' at week 7 (Group 3)
Quantitative ultrasound marker 'α' change.
Statistical analysis of the echo envelope: the scatterer clustering parameter α. This marker is unitless.
Measured: Change from baseline marker 'α' at week 4 (Groups 1, 2 and 3). Change from week-4 marker 'α' at week 7 (Group 3)
Quantitative ultrasound marker 'κ' change.
Statistical analysis of the echo envelope: the structure parameter κ. This marker is unitless.
Measured: Change from baseline marker 'κ' at week 4 (Groups 1, 2 and 3). Change from week-4 marker 'κ' at week 7 (Group 3)
Brief Pain Inventory short form 'pain severity' change.
The Brief Pain Inventory short form (BPI-sf) is a self-administered questionnaire used to assess the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The BPI-sf includes the four pain severity items (worst pain in last 24 hours, least pain in last 24 hours, pain on average, pain right now) and the seven interference items (general activity; mood; walking ability; normal work including housework; relations with other people; sleep; enjoyment of life). Each item is scored on an 11-point numerical rating scale (NRS) where 0 indicates no pain and 10 indicates worst pain imaginable. There is no scoring algorithm. The arithmetic mean of the four severity items will be used as measures of pain severity; the arithmetic mean of the seven interference items will be used as a measure of pain interference. The minimum and maximum values are 0 and 10 respectively. A higher score represents a worse outcome.
Measured: Change from baseline BPI-sf pain severity at week 4 (Groups 1, 2 and 3). Change from week-4 BPI-sf pain severity at week 7 (Group 3)
Brief Pain Inventory short form 'pain interference' change.
The Brief Pain Inventory short form (BPI-sf) is a self-administered questionnaire used to assess the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The BPI-sf includes the four pain severity items (worst pain in last 24 hours, least pain in last 24 hours, pain on average, pain right now) and the seven interference items (general activity; mood; walking ability; normal work including housework; relations with other people; sleep; enjoyment of life). Each item is scored on an 11-point numerical rating scale (NRS) where 0 indicates no pain and 10 indicates worst pain imaginable. There is no scoring algorithm. The arithmetic mean of the four severity items will be used as measures of pain severity; the arithmetic mean of the seven interference items will be used as a measure of pain interference. The minimum and maximum values are 0 and 10 respectively. A higher score represents a worse outcome.
Measured: Change from baseline BPI-sf pain interference at week 4 (Groups 1, 2 and 3). Change from week-4 BPI-sf pain interference at week 7 (Group 3)
Oswestry Disability Index (ODI) change.
Self-administered questionnaire. This test is widely used as a low back functional outcome tool. The minimum and maximum values are 0% and 100% respectively. A higher score means a worse outcome.
Measured: Change from baseline ODI at week 4 (Groups 1, 2 and 3). Change from week-4 ODI at week 7 (Group 3)
PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health Scale change.
Self-administered questionnaire. The PROMIS uses T scores. A score of 50 represents the mean of the concepts being measured, in the reference population. The standard deviation is 10. The range is from 0 to 100. Higher scores equals more of the concept being measured, therefore a better global health.
Measured: Change from baseline PROMIS Global Health at week 4 (Groups 1, 2 and 3). Change from week-4 PROMIS Global Health at week 7 (Group 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start1 Nov 2022
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Why it stopped: The grant money has been used up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Model description
- The patients will be randomized in three groups (allocation 1:1). Group 1 will receive a standardized acupuncture treatment and Group 2 will receive a standardized chiropractic treatment. Both groups will receive one treatment session per week for 3 consecutive weeks. Following the third treatment, at week 4, the US exam will be repeated and the questionnaires will be administered again. Group 3 will be placed on a waiting list for 3 weeks and will be reexamined by US and respond to the questionnaires at week 4. Then the group 3 patients will undergo a standardized therapeutic massage treatment consisting of one treatment session per week for 3 consecutive weeks. Following the third treatment, at week 7, the US exam will be repeated and the questionnaires will be administered again.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- 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
- NCT04843800
- Sponsor's protocol ID
- CE 21.003
- Other IDs
- 2021-AUDC-284121
- Status last verified
- Aug 2024
- First submitted
- 7 Apr 2021
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tomita N, Croteau D, Roy-Cardinal MH, Choiniere M, Benhaim L, Raby S, Boulanger A, Runquist J, Gaudreault N, Cloutier G, Bureau NJ. Quantitative ultrasound evaluation of the thoracolumbar fascia after manual and acupuncture therapies: an exploratory mechanistic randomized controlled trial with a sequential within-subject phase. Eur Radiol Exp. 2026 Jun 19;10(1):94. doi: 10.1186/s41747-026-00754-7.
PubMed 42319630
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Pain! Ultrasound-based Palpation and Visualization for Diagnosing Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04843800
- Acronym / sponsor ID
- CE 21.003
- Conditions
- Low Back Pain
- Keywords
- Ultrasound imaging, Elastography, Lumbar fascia, Acupuncture therapy, Manipulation, Chiropractic, Massage therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The grant money has been used up.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 14 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.
It is estimated that 23% of Quebecers suffer from chronic low back pain, and that 12% are disabled by this condition. Despite medical advances, the origin of so-called 'nonspecific low back pain' remains enigmatic. Conventional imaging methods by computed tomography and magnetic resonance may provide information on vertebral structures. However, very often, they do not diagnose lesions that genuinely correlate with the patient's symptoms. The lack of accurate diagnosis limits the therapeutic management in these patients.
Therefore, patients are increasingly turning to alternative and complementary medicine therapies (e.g., acupuncture, chiropractic , osteopathy, shiatsu) to relieve their pain. These therapies target painful areas of abnormal hardening in muscles of the lower back and aim to release the tension in these tissues to control pain. However, these painful areas and their resolution after manual therapy have yet to be demonstrated by means other than manual palpation. We will conduct a randomized controlled trial in chronic low back pain patients to examine the effects of acupuncture, chiropractic therapy and therapeutic massage on lower back muscular and connective tissues' physical properties using innovative ultrasound techniques.
Detailed description
This will be a phase II, prospective, randomized controlled study, which will have received IRB approval and will be registered at Clinicaltrials.gov before it begins. Participants with chronic non specific low back pain (NSLBP) will be recruited from one site. On the day of the registration visit, the participants will meet with the research assistant to review and sign the consent form, give clinical and demographic data and respond to validated outcome questionnaires.
The participants will then undergo a research dynamic ultrasound (US) of the lower back. One 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 passive flexion of the lower body. Following the US exam, the participants will be randomized in three groups (allocation 1:1). One group will receive a standardized acupuncture treatment and another group will receive a standardized chiropractic treatment. One treatment session per week for 3 consecutive weeks will be provided. Following the 3 treatment sessions, at week 4, the US exam will be repeated and the questionnaires will be administered.
The third group will be placed on a waiting list for 3 weeks and will be reexamined by US and respond to the questionnaires at week 4. Then, the participants will undergo a standardized therapeutic massage treatment with one treatment session per week for 3 consecutive weeks. Following the 3 treatment sessions, at week 7, the US exam will be repeated and the questionnaires will be administered.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The patients will be randomized in three groups (allocation 1:1). Group 1 will receive a standardized acupuncture treatment and Group 2 will receive a standardized chiropractic treatment. Both groups will receive one treatment session per week for 3 consecutive weeks. Following the third treatment, at week 4, the US exam will be repeated and the questionnaires will be administered again. Group 3 will be placed on a waiting list for 3 weeks and will be reexamined by US and respond to the questionnaires at week 4. Then the group 3 patients will undergo a standardized therapeutic massage treatment consisting of one treatment session per week for 3 consecutive weeks. Following the third treatment, at week 7, the US exam will be repeated and the questionnaires will be administered again.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: Manual therapyThe acupuncture treatments will consist of one 45-minute session weekly, for 3 consecutive weeks. The acupuncture treatment protocol will be semi standardized according to usual practice. All patients will be treated with a selection of local and distant points, comprising 10 minutes of insertion time, 30 minutes of needle retention and manipulation to achieve de qi (an irradiating feeling) if possible. |
| Chiropractic | Experimental | Procedure: Manual therapyThe chiropractic treatments will consist of one 20-minute session weekly, for 3 consecutive weeks. The Diversified technique is one of the most commonly practiced techniques by chiropractors. In the treatment of low back pain, this technique involves the application of a quick (high-velocity), short (low-amplitude) thrust (adjustment) to the lumbo-pelvic area. |
| Waiting list and Therapeutic Massage | Experimental | Procedure: Manual therapyThe therapeutic massage treatments will consist of one 45-minute session weekly, for 3 consecutive weeks. A technique called Fascial Release will be used. Tension related to back pain is believed to be present not only in the back but also in various parts of the body such as the legs, through the connection of fascia, the membrane that surrounds the muscles. The purpose of this treatment is to reduce the tension connected to the lower back. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ongoing 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 3 months;
- Pain has resulted in a problem on at least 50% of the days in the past 6 months;
- Only use of oral non-steroidal anti-inflammatory drugs for pain treatment in the 4 weeks before treatment;
- Willingness to commit to treatment sessions (acupuncture, chiropractic therapy or therapeutic massage) and to follow-up visits.
Key exclusion criteria (14 listed)
- Back pain attributable to a specific, recognizable, known pathology:
- History of spinal surgery;
- History of pelvis or hip fractures;
- Acupuncture, spinal manipulation or therapeutic massage for back pain within the past year;
- Severe clotting disorders or anticoagulant therapy;
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 |
|---|---|---|
| Manual therapyAcupuncture, Chiropractic are recognized complementary medicines and Therapeutic Massage is an alternative healing practice. | Procedure or surgery | Acupuncture, Chiropractic, Waiting list and Therapeutic Massage |
Primary outcome
% shear strain change.
Time frame: Change from baseline % shear strain at week 4 (Groups 1, 2 and 3). Change from week-4 % shear strain at week 7 (Group 3).
Percent shear strain between the thoracolumbar fascia and the epimysium of the erector spinae muscle.
7 secondary outcomes
Quantitative ultrasound marker 'μ' change.
Time frame: Change from baseline marker 'μ' at week 4 (Groups 1, 2 and 3). Change from week-4 marker 'μ' at week 7 (Group 3)
Quantitative ultrasound marker 'α' change.
Time frame: Change from baseline marker 'α' at week 4 (Groups 1, 2 and 3). Change from week-4 marker 'α' at week 7 (Group 3)
Quantitative ultrasound marker 'κ' change.
Time frame: Change from baseline marker 'κ' at week 4 (Groups 1, 2 and 3). Change from week-4 marker 'κ' at week 7 (Group 3)
Brief Pain Inventory short form 'pain severity' change.
Time frame: Change from baseline BPI-sf pain severity at week 4 (Groups 1, 2 and 3). Change from week-4 BPI-sf pain severity at week 7 (Group 3)
Brief Pain Inventory short form 'pain interference' change.
Time frame: Change from baseline BPI-sf pain interference at week 4 (Groups 1, 2 and 3). Change from week-4 BPI-sf pain interference at week 7 (Group 3)
Oswestry Disability Index (ODI) change.
Time frame: Change from baseline ODI at week 4 (Groups 1, 2 and 3). Change from week-4 ODI at week 7 (Group 3)
PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health Scale change.
Time frame: Change from baseline PROMIS Global Health at week 4 (Groups 1, 2 and 3). Change from week-4 PROMIS Global Health at week 7 (Group 3)
Results and safety
The study was stopped early (reason given: The grant money has been used up.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 42319630Tomita N, Croteau D, Roy-Cardinal MH, Choiniere M, Benhaim L, Raby S, Boulanger A, Runquist J, Gaudreault N, Cloutier G, Bureau NJ. Quantitative ultrasound evaluation of the thoracolumbar fascia after manual and acupuncture therapies: an exploratory mechanistic randomized controlled trial with a sequential within-subject phase. Eur Radiol Exp. 2026 Jun 19;10(1):94. doi: 10.1186/s41747-026-00754-7.
- 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 Manual therapy 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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 23 Aug 2024. 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 was stopped early (reason given: The grant money has been used up.). Results are not available in the source record.
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?
% shear strain change. (time frame: Change from baseline % shear strain at week 4 (Groups 1, 2 and 3). Change from week-4 % shear strain at week 7 (Group 3).). 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 NCT04843800, which also lists 1 linked publication.
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 23 Aug 2024.