Low Back PainPARA-ELASTONCT03750474
Comparison of the Stiffness of the Lumbar Back Muscles Between Low Back Pain and Healthy Controls
A study testing magnetic resonance elastography and shear wave elastography in people with Low Back Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Chronic low back pain remains a major public health issue. Low back pain is frequently associated with stiffness changes of the lumbar back muscles. The techniques which assess the stiffness of the back muscles are poorly reliable and do not allow the quantification of stiffness changes. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- magnetic resonance elastography and shear wave elastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2018to 1 May 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic low back pain (defined as low back pain for more than 3 months)
- Lumbar MRI without planned injection in chronic low back pain assessment
- Age between 18 and 80 years
- Ability to keep still in an MRI machine
- No contraindication to MRI
- No major sporting activity within 48 hours prior to the exam
Show all 12Show fewer
- Informed and written consent"
- No lumbar pain symptomatology, no lumbar static disorder, known neuromuscular pathology
- Age between 18 and 80 years
- Ability to keep still in an MRI machine
- No contraindication to MRI
- Informed and written consent
Who cannot join
- Inability to keep still in an MRI machine
- Intercurrent illness that may interfere with exam results
- Concomitant use of medications that may alter muscle metabolism
- Need to inject contrast during MRI
- Non-affiliation to a social security
- Minors, protected adults, persons unable to consent, persons under the protection of justice
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital Bicêtre - Radiology Department
Le Kremlin-Bicêtre, 94270
Maud CREZE, 01.45.21.33.73, Maud.creze@aphp.fr
Maud CREZE, PHU
About this study
Official title: Comparison of the Stiffness of the Lumbar Back Muscles Between Low Back Pain and Healthy Controls Using Magnetic Resonance Elastography and Shear Wave Elastography
Chronic low back pain remains a major public health issue. Low back pain is frequently associated with stiffness changes of the lumbar back muscles. The techniques which assess the stiffness of the back muscles are poorly reliable and do not allow the quantification of stiffness changes. Elastography (magnetic resonance imaging and ultrasound) can be used to objectively and non-invasively quantify in vivo tissue elasticity. The aim of the investigator's study is to compare the stiffness in the main lumbar back muscles (i.e. the erector spinae and the multifidus) by using magnetic resonance elastography and shear wave elastography.
Read the detailed description
"Chronic low back pain (CLBP) is commonly associated with increased trunk stiffness detected by quick release methods and motion track systems as well as increased back muscles stiffness identified by manual palpatory procedures or strain elastography. However, these techniques are qualitative and operator dependent, hence they remain poorly reliable.
Over the last decade, imaging techniques have become very helpful to characterize the biomechanical properties of tissues in vivo. Today, supersonic shear wave elastography (SWE) allows real time mapping of the elastic shear modulus. Also, magnetic resonance allows mapping and quantifying stiffness within a large volume of tissue. Elastography is efficient in the characterization of passive and active muscle forces, in highlighting the influence of muscle stiffness on joint stiffness and in showing stiffness changes related to muscle diseases Imaging plays a key role in the management of CLBP; It allows to reach specific radiological diagnosis such as tumor, inflammatory, or arthritis. However, in many cases, MRI did not find a specific cause to low back pain and the low back pain is reported as "non-specific". Myofascial disorders are also responsible for non-specific CLBP.
The main objective of this study is to compare the shear modulus of the main lumbar back muscles (erector spinae and multifidus) between patients with low back pain and healthy controls.
Second objectives are to assess: the relationship between the stiffness of the back muscles and clinical stiffness, the influence of age and sex on the elasticity of the back muscles, the relationship between the surface of the paravertebral muscles and the elasticity; the relationship between the elasticity of the hypaxial muscles (in front of the spine) and the epaxial muscles (behind the spine =back muscles), the relationship between fatty infiltration and elasticity of the back muscles, the relationship between inflammation / edema of back muscles and stiffness of the back muscles, the influence of the muscular stretching on the elasticity of the paravertebral muscles, the difference of elasticity in the direction of the muscle fibers (oblique coronal) and perpendicular (axial), the stiffness difference the between the right and left muscles, the role of different postures on muscle elasticity, the relationship between the elasticity of the back muscles and the intensity and type of pain, the relationship between the elasticity of the paravertebral muscles and disco-vertebral and / or posterior apophyseal pathology.
The inclusion of 26 patients and 26 controls will demonstrate a difference in mean elasticity modulus of 1.1 standard deviation (between patients and controls), with 90% and an alpha risk of 5%.
Patients will undergo an MRI (sagittal Short Inversion Time Inversion Recovery (STIR) and T1, coronal STIR and axial T1) in the management of low back pain. At the end of their examination, two elastography-sequences will be performed (axial and coronal plane). After the MRI, the patient will undergo a shear wave sonoelastography.
Healthy controls will undergo an MRI (sagittal T1 and T2) and two elastography-sequences (axial and coronal plane). After the MRI, the patient will undergo a an shear wave sonoelastography .
Healthy controls will be recruited in the hospital and university. Patients will be included when the appointment for MRI was made. Signed informant consent will be obtained after oral and written information.
The data manager will be trained to complete the case report form (CRF) and questionnaires; CRF and questionnaire. The entries that are not done according to procedure will result in inaccurate research data and inadequate source documentation. All data collected in the CRF will be scanned in a timely manner, then saved in an Exel folder, and initialized and dated by the data manager. Scanned data will be saved to the local database and on Universal Serial Bus (USB) disk. Computers designated for data entry, export and scanning will be password protected.
Data reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results were excluded.
Descriptive and comparative statistics will be done. The shear modulus will be compared between cases and controls using a Student's test (or Wilcoxon's test). For the secondary criteria, the comparison between qualitative variables will be made using the Chi² test, the comparison between a quantitative variable and a qualitative variable with a Student test (or Wilcoxon) or a one-way analysis of variance ( or Kruskal-Wallis test), the association between quantitative variables with the calculation of the Pearson (or Spearman) coefficient, depending on the conditions of application.
- Conditions
- Low Back Pain
- Being tested
- magnetic resonance elastography and shear wave elastography
- Keywords
- elastography; magnetic resonance imaging
- 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.
magnetic resonance elastography and shear wave elastographyDiagnostic test
magnetic resonance elastography and shear wave elastography of the back muscles
| Study group | Role | What they receive |
|---|---|---|
| patient with chronic low back pain | Experimental | magnetic resonance elastography and shear wave elastography of the back muscles Receives: Diagnostic Test: magnetic resonance elastography and shear wave elastography |
| healthy controls | Other | magnetic resonance elastography and shear wave elastography of the back muscles Receives: Diagnostic Test: magnetic resonance elastography and shear wave elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stiffness mapping and measurement of the shear modulus (m/s) in the multifidus and the erector spinae (1) with magnetic resonance elastography (Aera; 1,5T)
First, the subjects undergoes a magnetic resonance elastography in decubitus in two postures: at rest and with stretching of back muscles (hip flexion). Then, stiffness will be measurement with sonography in several postures: prone position, upright, bending forward, bending backward.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maud CREZE, PHU, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750474
- Sponsor's protocol ID
- K180403J
- Other IDs
- 2017-A02799-44
- Acronym
- PARA-ELASTO
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Stiffness of the Lumbar Back Muscles Between Low Back Pain and Healthy Controls Using Magnetic Resonance Elastography and Shear Wave Elastography
- ClinicalTrials.gov ID
- NCT03750474
- Acronym / sponsor ID
- PARA-ELASTO / K180403J
- Conditions
- Low Back Pain
- Keywords
- elastography; magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 23 Nov 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.
Chronic low back pain remains a major public health issue. Low back pain is frequently associated with stiffness changes of the lumbar back muscles. The techniques which assess the stiffness of the back muscles are poorly reliable and do not allow the quantification of stiffness changes. Elastography (magnetic resonance imaging and ultrasound) can be used to objectively and non-invasively quantify in vivo tissue elasticity. The aim of the investigator's study is to compare the stiffness in the main lumbar back muscles (i.e. the erector spinae and the multifidus) by using magnetic resonance elastography and shear wave elastography.
Detailed description
"Chronic low back pain (CLBP) is commonly associated with increased trunk stiffness detected by quick release methods and motion track systems as well as increased back muscles stiffness identified by manual palpatory procedures or strain elastography. However, these techniques are qualitative and operator dependent, hence they remain poorly reliable.
Over the last decade, imaging techniques have become very helpful to characterize the biomechanical properties of tissues in vivo. Today, supersonic shear wave elastography (SWE) allows real time mapping of the elastic shear modulus. Also, magnetic resonance allows mapping and quantifying stiffness within a large volume of tissue. Elastography is efficient in the characterization of passive and active muscle forces, in highlighting the influence of muscle stiffness on joint stiffness and in showing stiffness changes related to muscle diseases Imaging plays a key role in the management of CLBP; It allows to reach specific radiological diagnosis such as tumor, inflammatory, or arthritis. However, in many cases, MRI did not find a specific cause to low back pain and the low back pain is reported as "non-specific". Myofascial disorders are also responsible for non-specific CLBP.
The main objective of this study is to compare the shear modulus of the main lumbar back muscles (erector spinae and multifidus) between patients with low back pain and healthy controls.
Second objectives are to assess: the relationship between the stiffness of the back muscles and clinical stiffness, the influence of age and sex on the elasticity of the back muscles, the relationship between the surface of the paravertebral muscles and the elasticity; the relationship between the elasticity of the hypaxial muscles (in front of the spine) and the epaxial muscles (behind the spine =back muscles), the relationship between fatty infiltration and elasticity of the back muscles, the relationship between inflammation / edema of back muscles and stiffness of the back muscles, the influence of the muscular stretching on the elasticity of the paravertebral muscles, the difference of elasticity in the direction of the muscle fibers (oblique coronal) and perpendicular (axial), the stiffness difference the between the right and left muscles, the role of different postures on muscle elasticity, the relationship between the elasticity of the back muscles and the intensity and type of pain, the relationship between the elasticity of the paravertebral muscles and disco-vertebral and / or posterior apophyseal pathology.
The inclusion of 26 patients and 26 controls will demonstrate a difference in mean elasticity modulus of 1.1 standard deviation (between patients and controls), with 90% and an alpha risk of 5%.
Patients will undergo an MRI (sagittal Short Inversion Time Inversion Recovery (STIR) and T1, coronal STIR and axial T1) in the management of low back pain. At the end of their examination, two elastography-sequences will be performed (axial and coronal plane). After the MRI, the patient will undergo a shear wave sonoelastography.
Healthy controls will undergo an MRI (sagittal T1 and T2) and two elastography-sequences (axial and coronal plane). After the MRI, the patient will undergo a an shear wave sonoelastography .
Healthy controls will be recruited in the hospital and university. Patients will be included when the appointment for MRI was made. Signed informant consent will be obtained after oral and written information.
The data manager will be trained to complete the case report form (CRF) and questionnaires; CRF and questionnaire. The entries that are not done according to procedure will result in inaccurate research data and inadequate source documentation. All data collected in the CRF will be scanned in a timely manner, then saved in an Exel folder, and initialized and dated by the data manager. Scanned data will be saved to the local database and on Universal Serial Bus (USB) disk. Computers designated for data entry, export and scanning will be password protected.
Data reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results were excluded.
Descriptive and comparative statistics will be done. The shear modulus will be compared between cases and controls using a Student's test (or Wilcoxon's test). For the secondary criteria, the comparison between qualitative variables will be made using the Chi² test, the comparison between a quantitative variable and a qualitative variable with a Student test (or Wilcoxon) or a one-way analysis of variance ( or Kruskal-Wallis test), the association between quantitative variables with the calculation of the Pearson (or Spearman) coefficient, depending on the conditions of application.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with chronic low back pain | Experimental | Diagnostic Test: magnetic resonance elastography and shear wave elastographymagnetic resonance elastography and shear wave elastography of the back muscles |
| healthy controls | Other | Diagnostic Test: magnetic resonance elastography and shear wave elastographymagnetic resonance elastography and shear wave elastography of the back muscles |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Chronic low back pain (defined as low back pain for more than 3 months)
- Lumbar MRI without planned injection in chronic low back pain assessment
- Age between 18 and 80 years
- Ability to keep still in an MRI machine
- No contraindication to MRI
Key exclusion criteria (6 listed)
- Inability to keep still in an MRI machine
- Intercurrent illness that may interfere with exam results
- Concomitant use of medications that may alter muscle metabolism
- Need to inject contrast during MRI
- Non-affiliation to a social security
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 |
|---|---|---|
| magnetic resonance elastography and shear wave elastographymagnetic resonance elastography and shear wave elastography of the back muscles | Diagnostic test | healthy controls, patient with chronic low back pain |
Primary outcome
Stiffness mapping and measurement of the shear modulus (m/s) in the multifidus and the erector spinae (1) with magnetic resonance elastography (Aera; 1,5T)
Time frame: 18 months
First, the subjects undergoes a magnetic resonance elastography in decubitus in two postures: at rest and with stretching of back muscles (hip flexion). Then, stiffness will be measurement with sonography in several postures: prone position, upright, bending forward, bending backward.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Maud CREZE, PHU principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance elastography and shear wave elastography in people with Low Back Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 12 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maud CREZE (0145213377, maud.creze@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stiffness mapping and measurement of the shear modulus (m/s) in the multifidus and the erector spinae (1) with magnetic resonance elastography (Aera; 1,5T) (time frame: 18 months). 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 23 Nov 2018.