DiscopathyMODISCNCT04142580
Correlation Between RMI of Degenerative Disk Disease and Reduction of Pain After Disk-infiltration Treatments
An observational study of Discopathy and Lumbago, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective of the study is to demonstrate the difference in the reduction of pain at 1 month after intradiscal infiltration of corticosteroids depending on symmetrical or asymmetrical active discopathies with MRI examination. The difference should be judged significant if it ⩾ 2 points. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Discopathy, Lumbago
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2019to 28 Dec 2021
- Phase
- Observational
- 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
Study population: The study population corresponds to patients suffering from chronic low back pain lasting for at least 3 months and disabling, in failure of the recommended drug treatment, with presence of lumbar active discopathy (Modic 1) by MRI examination, recommended by their referring physician, rheumatologist, physician reeducator, orthopedic surgeon or neurosurgeon in the diagnostic and interventional medical imaging department of the Raymond Poincaré Hospital in Garches, for intradiscal infiltration of corticosteroids. This population corresponds to patients treated daily in routine practice by intradiscal infiltration in the institution.
Who may be able to join
- Age ⩾ 18 years.
- Chronic growing lumbago with duration > 3 mois.
- Disabling lumbago with an average ⩾ 4/10 defined by numerical scale.
- Common chronic low back pain that has been evolving for more than 3 months.
- Disabling lumbalgia defined by an average numerical scale greater than or equal to 4/10 in the month preceding the inclusion.
- Failure or intolerance to drug treatments (nonsteroidal anti-inflammatory drugs and systemic corticosteroids).
Show all 10Show fewer
- Absence of biological inflammatory syndrome.
- Recent MRI of less than 6 months with active disc disease (Modic 1) defined by degenerative disc disease associated with mirror rearrangements of the subchondral bone of the adjacent vertebral endplates in hyposignal T1 and hypersignal T2.
- Signed informed consent obtained.
- Affiliation to social security.
Who cannot join
- Pregnancy woman.
- Immunosuppression.
- History of allergy to iodinated contrast agents and / or prednisolone acetate.
- Local or general infection.
- Fever (temperature> 38).
- History of disc surgery of less than 6 months.
Show all 11Show fewer
- History of infectious spondylodiscitis.
- Unbalanced psychiatric disorders.
- Severe coagulation disorders or impossible cessation of anticoagulation or anti platelet aggregation.
- Impossibility to obtain signed consent form.
- Patient under guardianship and/or curatorship.
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, France
Garche, 92380
About this study
Official title: Evolution of Chronic Low Back Pain of Active Discopathy After Intradiscal Corticosteroid Infiltrations According to Modic 1 Distribution and Association With Degenerative Restructuring
The primary objective of the study is to demonstrate the difference in the reduction of pain at 1 month after intradiscal infiltration of corticosteroids depending on symmetrical or asymmetrical active discopathies with MRI examination. The difference should be judged significant if it ⩾ 2 points.
Read the detailed description
As secondary objective, the study aims to study the correlation between pain reduction which will be assessed by numerical scale at 1 month and 6 months after intradiscal infiltration of corticosteroids and following parameters: the duration of chronic lumbago, the presence of associated root pains, the morphological characteristics with RMI examination of active discopathies, the co-existence of scoliosis, the sign of inter-somatic instability, the muscular trophicity of muscle erector of low back, the pelvic incidence, degree of lumbar lordosis, Cobb angle, wearing a corset.
- Conditions
- Discopathy, Lumbago
- Keywords
- discopathy, chronic lumbago, degenerative, Modic 1
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessement of change in pain
The change in pain will be evaluated by numerical scale NRS (numeric rating scale) by phone call after intradiscal infiltration of corticosteroids.
NRS for pain: a scale from 0 (no pain) to 10 (worst pain). RMI examination will be performed 6 months before enrollment.
Measured: at 1 month
Secondary outcomes (6)
Assessement of pain reduction according to the duration of evolution of chronic lumbago
The change in pain will be evaluated by NRS for pain (numeric rating scale for pain, a scale from 0 to 10) by phone call after intradiscal infiltration of corticosteroids, according to the duration of evolution of chronic lumbago or not will be assessed. Duration of pain before infiltration will be evaluated in months during the pre-inclusion consultation.
Measured: at 1 month and 6 months
Assessement of pain reduction according to the presence of associated root pains or not.
The presence of associated root pains will be evaluated by NRS for pain (numerical rating scale, a scale from 0 to 10) by phone call after intradiscal infiltration of corticosteroids, according to the presence of associated root pains or not will be assessed. Patients will be asked if there is any root pain during the pre-inclusion consultation.
Measured: at 1 month and 6 months
Assessement of pain reduction according to the co-existence of scoliosis or not.
The pain reduction and the co-existence of scoliosis will be assessed. The change in pain will be evaluated by NRS for pain (numeric rating scale, a scale from 0 to 10) by phone call after intradiscal infiltration of corticosteroids, according to the presence of associated scoliosis or not will be assessed. Scoliosis will be investigated by interviewing the patient and analyzing the patient's x-rays, performed as part of routine care prior to the pre-inclusion consultation. Scoliosis is any lateral spinal curvature with a Cobb angle >10° on x-rays.
Measured: at 1 month and 6 months
Assessement of pain reduction according to the presence of signs of inter-somatic instability
The change in pain will be evaluated by NRS for pain (numeric rating scale, a scale from 0 to 10) by phone call after intradiscal infiltration of corticosteroids, according to the presence of signs of inter-somatic instability or not will be assessed. Signs of inter-somatic instability will be investigated by interviewing the patient and analyzing the patient's x-rays and MRI, performed as part of routine care prior to the pre-inclusion consultation. Intersomatic instability is defined as the anterior, posterior or lateral translational displacement of a vertebral body against another (more than 3 mm) on x-rays or MRI.
Measured: at 1 month and 6 months
Assessement of pain reduction according to the presence of posterior articular osteoarthritis
The change in pain will be evaluated by NRS for pain (numeric rating scale, a scale from 0 to 10) by phone call after intradiscal infiltration of corticosteroids, according to the presence of posterior articular osteoarthritis or not will be assessed. Signs of posterior articular osteoarthritis will be investigated by interviewing the patient and analyzing the patient's x-rays and MRI, performed as part of routine care prior to the pre-inclusion consultation. Posterior articular osteoarthritis will be defined by the presence of bone protrusions, narrowing of joint space, effusion of the joint and periarticular inflammation on x-rays or MRI.
Measured: at 1 month and 6 months
Assessement of pain reduction according to the muscle trophicity of the erector muscles of the lumbar spine
The change in pain will be evaluated by NRS for pain (numeric rating scale, a scale from 0 to 10) by phone call after intradiscal infiltration of corticosteroids, according to the presence of an atrophy of the erector muscles of the lumbar spine or not will be assessed. Signs of atrophy of the erector muscles of the lumbar spine will be investigated by interviewing the patient and analyzing the patient's MRI, performed as part of routine care prior to the pre-inclusion consultation. Atrophy of the erector muscles of the lumbar spine will be defined by the presence fat infiltration in erector muscles of the lumbar spine MRI.
Measured: at 1 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start13 Nov 2019
- Primary completion28 Dec 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DiscopathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert-Yves CARLIER, MD, PhD, Study director, Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, FranceTristan THIRY, MD, Principal investigator, Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142580
- Sponsor's protocol ID
- APHP190560
- Other IDs
- 2019-AO1561-56
- Acronym
- MODISC
- Status last verified
- Sep 2023
- First submitted
- 26 Sep 2019
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
PubMed 30496104Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
PubMed 22231424Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008 Jan-Feb;8(1):8-20. doi: 10.1016/j.spinee.2007.10.005.
PubMed 18164449Hueftle MG, Modic MT, Ross JS, Masaryk TJ, Carter JR, Wilber RG, Bohlman HH, Steinberg PM, Delamarter RB. Lumbar spine: postoperative MR imaging with Gd-DTPA. Radiology. 1988 Jun;167(3):817-24. doi: 10.1148/radiology.167.3.2966418.
PubMed 2966418Albert HB, Kjaer P, Jensen TS, Sorensen JS, Bendix T, Manniche C. Modic changes, possible causes and relation to low back pain. Med Hypotheses. 2008;70(2):361-8. doi: 10.1016/j.mehy.2007.05.014. Epub 2007 Jul 10.
PubMed 17624684Toyone T, Takahashi K, Kitahara H, Yamagata M, Murakami M, Moriya H. Vertebral bone-marrow changes in degenerative lumbar disc disease. An MRI study of 74 patients with low back pain. J Bone Joint Surg Br. 1994 Sep;76(5):757-64.
PubMed 8083266Nguyen C, Jousse M, Poiraudeau S, Feydy A, Rannou F. Intervertebral disc and vertebral endplate subchondral changes associated with Modic 1 changes of the lumbar spine: a cross-sectional study. BMC Musculoskelet Disord. 2017 Jan 23;18(1):34. doi: 10.1186/s12891-017-1407-6.
PubMed 28114923Nguyen C, Poiraudeau S, Rannou F. From Modic 1 vertebral-endplate subchondral bone signal changes detected by MRI to the concept of 'active discopathy'. Ann Rheum Dis. 2015 Aug;74(8):1488-94. doi: 10.1136/annrheumdis-2015-207317. Epub 2015 May 14.
PubMed 25977562Nguyen C, Boutron I, Baron G, Sanchez K, Palazzo C, Benchimol R, Paris G, James-Belin E, Lefevre-Colau MM, Beaudreuil J, Laredo JD, Bera-Louville A, Cotten A, Drape JL, Feydy A, Ravaud P, Rannou F, Poiraudeau S. Intradiscal Glucocorticoid Injection for Patients With Chronic Low Back Pain Associated With Active Discopathy: A Randomized Trial. Ann Intern Med. 2017 Apr 18;166(8):547-556. doi: 10.7326/M16-1700. Epub 2017 Mar 21.
PubMed 28319997Benyahya R, Lefevre-Colau MM, Fayad F, Rannou F, Demaille-Wlodyka S, Mayoux-Benhamou MA, Poiraudeau S, Revel M. [Intradiscal injection of acetate of prednisolone in severe low back pain: complications and patients' assessment of effectiveness]. Ann Readapt Med Phys. 2004 Nov;47(9):621-6. doi: 10.1016/j.annrmp.2004.05.020. French.
PubMed 15539069
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Chronic Low Back Pain of Active Discopathy After Intradiscal Corticosteroid Infiltrations According to Modic 1 Distribution and Association With Degenerative Restructuring
- ClinicalTrials.gov ID
- NCT04142580
- Acronym / sponsor ID
- MODISC / APHP190560
- Conditions
- Discopathy, Lumbago
- Keywords
- discopathy, chronic lumbago, degenerative, Modic 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 29 Oct 2019 (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.
The primary objective of the study is to demonstrate the difference in the reduction of pain at 1 month after intradiscal infiltration of corticosteroids depending on symmetrical or asymmetrical active discopathies with MRI examination. The difference should be judged significant if it ⩾ 2 points.
Detailed description
As secondary objective, the study aims to study the correlation between pain reduction which will be assessed by numerical scale at 1 month and 6 months after intradiscal infiltration of corticosteroids and following parameters: the duration of chronic lumbago, the presence of associated root pains, the morphological characteristics with RMI examination of active discopathies, the co-existence of scoliosis, the sign of inter-somatic instability, the muscular trophicity of muscle erector of low back, the pelvic incidence, degree of lumbar lordosis, Cobb angle, wearing a corset.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population corresponds to patients suffering from chronic low back pain lasting for at least 3 months and disabling, in failure of the recommended drug treatment, with presence of lumbar active discopathy (Modic 1) by MRI examination, recommended by their referring physician, rheumatologist, physician reeducator, orthopedic surgeon or neurosurgeon in the diagnostic and interventional medical imaging department of the Raymond Poincaré Hospital in Garches, for intradiscal infiltration of corticosteroids. This population corresponds to patients treated daily in routine practice by intradiscal infiltration in the institution.
Key inclusion criteria (10 listed)
- Age ⩾ 18 years.
- Chronic growing lumbago with duration > 3 mois.
- Disabling lumbago with an average ⩾ 4/10 defined by numerical scale.
- Common chronic low back pain that has been evolving for more than 3 months.
- Disabling lumbalgia defined by an average numerical scale greater than or equal to 4/10 in the month preceding the inclusion.
Key exclusion criteria (11 listed)
- Pregnancy woman.
- Immunosuppression.
- History of allergy to iodinated contrast agents and / or prednisolone acetate.
- Local or general infection.
- Fever (temperature> 38).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessement of change in pain
Time frame: at 1 month
The change in pain will be evaluated by numerical scale NRS (numeric rating scale) by phone call after intradiscal infiltration of corticosteroids. NRS for pain: a scale from 0 (no pain) to 10 (worst pain). RMI examination will be performed 6 months before enrollment.
6 secondary outcomes
Assessement of pain reduction according to the duration of evolution of chronic lumbago
Time frame: at 1 month and 6 months
Assessement of pain reduction according to the presence of associated root pains or not.
Time frame: at 1 month and 6 months
Assessement of pain reduction according to the co-existence of scoliosis or not.
Time frame: at 1 month and 6 months
Assessement of pain reduction according to the presence of signs of inter-somatic instability
Time frame: at 1 month and 6 months
Assessement of pain reduction according to the presence of posterior articular osteoarthritis
Time frame: at 1 month and 6 months
Assessement of pain reduction according to the muscle trophicity of the erector muscles of the lumbar spine
Time frame: at 1 month and 6 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 21 Sep 2023.
- Background: PubMed 30496104GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
- Background: PubMed 22231424Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
- Background: PubMed 18164449Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008 Jan-Feb;8(1):8-20. doi: 10.1016/j.spinee.2007.10.005.
- Background: PubMed 2966418Hueftle MG, Modic MT, Ross JS, Masaryk TJ, Carter JR, Wilber RG, Bohlman HH, Steinberg PM, Delamarter RB. Lumbar spine: postoperative MR imaging with Gd-DTPA. Radiology. 1988 Jun;167(3):817-24. doi: 10.1148/radiology.167.3.2966418.
- Background: PubMed 17624684Albert HB, Kjaer P, Jensen TS, Sorensen JS, Bendix T, Manniche C. Modic changes, possible causes and relation to low back pain. Med Hypotheses. 2008;70(2):361-8. doi: 10.1016/j.mehy.2007.05.014. Epub 2007 Jul 10.
- Background: PubMed 8083266Toyone T, Takahashi K, Kitahara H, Yamagata M, Murakami M, Moriya H. Vertebral bone-marrow changes in degenerative lumbar disc disease. An MRI study of 74 patients with low back pain. J Bone Joint Surg Br. 1994 Sep;76(5):757-64.
- Background: PubMed 28114923Nguyen C, Jousse M, Poiraudeau S, Feydy A, Rannou F. Intervertebral disc and vertebral endplate subchondral changes associated with Modic 1 changes of the lumbar spine: a cross-sectional study. BMC Musculoskelet Disord. 2017 Jan 23;18(1):34. doi: 10.1186/s12891-017-1407-6.
- Background: PubMed 25977562Nguyen C, Poiraudeau S, Rannou F. From Modic 1 vertebral-endplate subchondral bone signal changes detected by MRI to the concept of 'active discopathy'. Ann Rheum Dis. 2015 Aug;74(8):1488-94. doi: 10.1136/annrheumdis-2015-207317. Epub 2015 May 14.
- Background: PubMed 28319997Nguyen C, Boutron I, Baron G, Sanchez K, Palazzo C, Benchimol R, Paris G, James-Belin E, Lefevre-Colau MM, Beaudreuil J, Laredo JD, Bera-Louville A, Cotten A, Drape JL, Feydy A, Ravaud P, Rannou F, Poiraudeau S. Intradiscal Glucocorticoid Injection for Patients With Chronic Low Back Pain Associated With Active Discopathy: A Randomized Trial. Ann Intern Med. 2017 Apr 18;166(8):547-556. doi: 10.7326/M16-1700. Epub 2017 Mar 21.
- Background: PubMed 15539069Benyahya R, Lefevre-Colau MM, Fayad F, Rannou F, Demaille-Wlodyka S, Mayoux-Benhamou MA, Poiraudeau S, Revel M. [Intradiscal injection of acetate of prednisolone in severe low back pain: complications and patients' assessment of effectiveness]. Ann Readapt Med Phys. 2004 Nov;47(9):621-6. doi: 10.1016/j.annrmp.2004.05.020. French.
- 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.
Robert-Yves CARLIER, MD, PhD study director
Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, France
Tristan THIRY, MD principal investigator
Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Discopathy and Lumbago, 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 10 inclusion and 11 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 21 Sep 2023. 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?
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?
Assessement of change in pain (time frame: at 1 month). 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 NCT04142580, which also lists 10 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 21 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.