Correlation Between RMI of Degenerative Disk Disease and Reduction of Pain After Disk-infiltration Treatments (MODISC)

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.

Study Overview

• Status: Completed
• Conditions: Lumbago; Discopathy

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 Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

• Study Contact: Name: Tristan THIRY, MD; Phone Number: +33147107042; Email: t.thiry@outlook.com
• Study Contact Backup: Name: Robert-Yves CARLIER, MD, PhD; Phone Number: +331 47 10 70 40; Email: robert.carlier@aphp.fr

Study Locations

• France
  • Garche, France, 92380
    • Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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).
• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	at 1 month and 6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Robert-Yves CARLIER, MD, PhD, Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, France; Principal Investigator: Tristan THIRY, MD, Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, France

Publications and helpful links

General Publications

• Hoy 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.
• Dagenais 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.
• Toyone 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.
• 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. Erratum In: Lancet. 2019 Jun 22;393(10190):e44.
• Albert 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.
• Hueftle 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.
• Nguyen 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.
• Nguyen 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.
• Nguyen 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.
• Benyahya 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Actual): December 28, 2021
• Study Completion (Actual): December 28, 2021

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Modic 1; degenerative; discopathy; chronic lumbago
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: APHP190560 (ANSM); 2019-AO1561-56 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No