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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Discopathy; Lumbago

Study type: Observational

Funder types: Other

Identifiers

NCT04142580

2019-AO1561-56

APHP190560 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.