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

NCT04142580 | Completed

• 2 other identifiers: APHP1905602019-AO1561-56
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Discopathy; Lumbago

Keywords

discopathy; chronic lumbago; degenerative; Modic 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Assessement of pain reduction according to the duration of evolution of chronic lumbago

  at 1 month and 6 months

• Assessement of pain reduction according to the presence of associated root pains or not.

  at 1 month and 6 months

• Assessement of pain reduction according to the co-existence of scoliosis or not.

  at 1 month and 6 months

• Assessement of pain reduction according to the presence of signs of inter-somatic instability

  at 1 month and 6 months

• Assessement of pain reduction according to the presence of posterior articular osteoarthritis

  at 1 month and 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, France

Garche, 92380, France

Location

Related Publications (10)

• 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.

  PMID: 30496104 BACKGROUND

• 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.

  PMID: 22231424 BACKGROUND

• 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.

  PMID: 18164449 BACKGROUND

• 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.

  PMID: 2966418 BACKGROUND

• 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.

  PMID: 17624684 BACKGROUND

• 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.

  PMID: 8083266 BACKGROUND

• 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.

  PMID: 28114923 BACKGROUND

• 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.

  PMID: 25977562 BACKGROUND

• 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.

  PMID: 28319997 BACKGROUND

• 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.

  PMID: 15539069 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert-Yves CARLIER, MD, PhD

  Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, France

  STUDY DIRECTOR

• Tristan THIRY, MD

  Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 29, 2019
• Study Start: November 13, 2019
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)