Clinical trial NCT04142580: Correlation Between RMI of Degenerative Disk Disease and Reduction of Pain After Disk-infiltration Treatments
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Discopathy
Lumbago
Keywords: discopathy
chronic lumbago
degenerative
Modic 1
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessement of change in pain
timeFrame: at 1 month
Secondary outcomes:
measure: Assessement of pain reduction according to the duration of evolution of chronic lumbago
timeFrame: at 1 month and 6 months
measure: Assessement of pain reduction according to the presence of associated root pains or not.
timeFrame: at 1 month and 6 months
measure: Assessement of pain reduction according to the co-existence of scoliosis or not.
timeFrame: at 1 month and 6 months
measure: Assessement of pain reduction according to the presence of signs of inter-somatic instability
timeFrame: at 1 month and 6 months
measure: Assessement of pain reduction according to the presence of posterior articular osteoarthritis
timeFrame: at 1 month and 6 months
measure: Assessement of pain reduction according to the muscle trophicity of the erector muscles of the lumbar spine
timeFrame: at 1 month and 6 months
Other outcomes:
Locations:
city: Garche
country: France
facility: Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, France
Study officials:
affiliation: Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, France
name: Robert-Yves CARLIER, MD, PhD
role: STUDY_DIRECTOR
affiliation: Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, France
name: Tristan THIRY, MD
role: PRINCIPAL_INVESTIGATOR
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