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

September 18, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessement of change in pain
Time Frame: 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.
at 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessement of pain reduction according to the duration of evolution of chronic lumbago
Time Frame: 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.
at 1 month and 6 months
Assessement of pain reduction according to the presence of associated root pains or not.
Time Frame: 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.
at 1 month and 6 months
Assessement of pain reduction according to the co-existence of scoliosis or not.
Time Frame: 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.
at 1 month and 6 months
Assessement of pain reduction according to the presence of signs of inter-somatic instability
Time Frame: 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.
at 1 month and 6 months
Assessement of pain reduction according to the presence of posterior articular osteoarthritis
Time Frame: 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.
at 1 month and 6 months
Assessement of pain reduction according to the muscle trophicity of the erector muscles of the lumbar spine
Time Frame: 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.
at 1 month and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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