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

Completed

• Conditions: Discopathy; Lumbago

• Registration Number: NCT04142580
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-29
• Study Start: 2019-11-13
• Primary Completion: 2021-12-28
• Study Completion: 2021-12-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessement of change in pain	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.

Secondary Outcome Measures

Name	Time	Method
Assessement of pain reduction according to the duration of evolution of chronic lumbago	at 1 month and 6 months	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.
Assessement of pain reduction according to the co-existence of scoliosis or not.	at 1 month and 6 months	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.
Assessement of pain reduction according to the presence of signs of inter-somatic instability	at 1 month and 6 months	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.
Assessement of pain reduction according to the presence of posterior articular osteoarthritis	at 1 month and 6 months	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.
Assessement of pain reduction according to the presence of associated root pains or not.	at 1 month and 6 months	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.
Assessement of pain reduction according to the muscle trophicity of the erector muscles of the lumbar spine	at 1 month and 6 months	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.

Trial Locations

Locations (1)

Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, France; 🇫🇷 Garche, France