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Evaluating the Efficacy of Para-discal Infiltration in Patients With Lateralized MODIC 1 Inflammatory Disc Disease (IPAD)

Primary Purpose

Degenerative Disc Disease, Inflammation, Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Para-discal injection of corticoid
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Low back pain, Injections, Degenerative Disc Disease, Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient 18 years of age or older Patient with Modic I lateralized disc disease seen on an MRI less than 6 months old. Chronic medial or lateralized (same side as MODIC 1) low back pain for at least 3 months with a mean pain intensity ≥ 40/100 mm on a VAS. Effective contraception for women of childbearing age, at least 6 months after injection (surgical sterilisation, approved hormonal contraceptives, barrier methods, intrauterine intrauterine device) Exclusion Criteria: Patient with MODIC 1 in both underlying and overlying vertebral spaces. Patient with an inflammatory signal abnormality of the vertebral body plateau related to non-mechanical pathology (e.g. spondyloarthritis). Patients with a history of lumbar spine surgery. Patient with suspected spondylodiscitis or other infection. Patients on anticoagulant or antiaggregant therapy, or with a coagulation disorder. Patients with an allergy to iodine or to any of the components of Xylocaine. Patients with an allergy to prednisolone or to any component of Hydrocortancyl® or Dexamethasone®.. Patient with severe uncontrolled disease (i.e. cardiac gastrointestinal, neurological, endocrine, autoimmune) that limits patient safety (as determined by the safety (as judged by the investigator). Prior to the treatment visit : current and recent morphine use (< 1 month) recent systemic or local corticosteroid therapy (< 1 month). Patient with sphincter disturbances indicative of cauda equina syndrome. Psychotic state not controlled by treatment Pregnancy (βHCG positive), breastfeeding Vulnerable patient protected by law Patient under guardianship or curatorship Patient participating in an interventional study Patient unable to read and/or write

Sites / Locations

  • Departement of Medical ImagingRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Para-discal infiltration

Arm Description

Single arm study

Outcomes

Primary Outcome Measures

Change from Baseline pain using the Visual Analogue Scale (VAS) at 1 month
VAS pain is a subjective but simple and reproducible criterion and one of the most widely used to evaluate the effectiveness of a therapeutic strategy in chronic low back pain. 0 represents no pain and 100 represents the worst pain imaginable.

Secondary Outcome Measures

Concomitant treatments (analgesics/NSAIDs)
he use of analgesics or NSAIDs will be recorded throughout the study by direct questioning of the patient and/or through their medical records.
Change from The Oswestry Disability Index (ODI) at 1 month
The Oswestry Disability Index (ODI) is a validated questionnaire (Fairbank and Pynsent 2000). We will consider a patient as responder if he/she manages to achieve at least 30% improvement in ODI score between baseline and 1 month. This percentage of minimal improvement (30%) was judged to be a clinically relevant threshold by an international consensus conference (Ostelo et al. 2008).
Change from Baseline Pain using the Visual Analogue Scale (VAS) at 7 days
VAS pain is a subjective but simple and reproducible criterion and one of the most widely used to evaluate the effectiveness of a therapeutic strategy in chronic low back pain. 0 represents no pain and 100 represents the worst pain imaginable.
Change from Baseline Pain using the Visual Analogue Scale (VAS) at 3 months
VAS pain is a subjective but simple and reproducible criterion and one of the most widely used to evaluate the effectiveness of a therapeutic strategy in chronic low back pain. 0 represents no pain and 100 represents the worst pain imaginable.
Change from Baseline Pain using the Visual Analogue Scale (VAS) at 6 months
VAS pain is a subjective but simple and reproducible criterion and one of the most widely used to evaluate the effectiveness of a therapeutic strategy in chronic low back pain. 0 represents no pain and 100 represents the worst pain imaginable.

Full Information

First Posted
October 27, 2022
Last Updated
August 9, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05615597
Brief Title
Evaluating the Efficacy of Para-discal Infiltration in Patients With Lateralized MODIC 1 Inflammatory Disc Disease
Acronym
IPAD
Official Title
Evaluating the Efficacy of Para-discal Infiltration in Patients With Lateralized MODIC 1 Inflammatory Disc Disease: Pilot Study (IPAD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2022 (Actual)
Primary Completion Date
June 22, 2024 (Anticipated)
Study Completion Date
November 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Degenerative disc disease (DDD) is a major cause of chronic low back pain (> 40%). It can be defined by specific magnetic resonance imaging (MRI) features, with a strong correlation between pain and the inflammatory aspect of the disc, resulting in active disc disease (AD). The Modic classification based on MRI of the lumbar spine is considered a reference. The management of low back pain in patients with inflammatory disc disease generally involves intra-disc corticosteroid infiltration, which has been widely proven to be effective in reducing pain [4-6]. However, this procedure can be painful and invasive and sometimes impossible to perform due to severe disc impingement. The aim of this study is to evaluate the efficacy on pain of para-disc infiltration of corticosteroids in contact with the inflammatory MRI signal abnormality (Modic 1) when it is lateralized. This variant of infiltration is easier to perform (no catheterisation of the disc and therefore quicker), would entail less risk of disc infection and would be accessible to more radiologists. It is already practised but, to our knowledge, has never been the subject of a study to evaluate its effectiveness on pain. If successful, more patients could be treated and the range of treatment could be extended.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Inflammation, Low Back Pain
Keywords
Low back pain, Injections, Degenerative Disc Disease, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Para-discal infiltration
Arm Type
Other
Arm Description
Single arm study
Intervention Type
Procedure
Intervention Name(s)
Para-discal injection of corticoid
Intervention Description
In this pilot study, all patients underwent the same procedure: a corticosteroid infiltration via a para-discal approach. The infiltrations were performed under CT or scopy.
Primary Outcome Measure Information:
Title
Change from Baseline pain using the Visual Analogue Scale (VAS) at 1 month
Description
VAS pain is a subjective but simple and reproducible criterion and one of the most widely used to evaluate the effectiveness of a therapeutic strategy in chronic low back pain. 0 represents no pain and 100 represents the worst pain imaginable.
Time Frame
1 month after intervention
Secondary Outcome Measure Information:
Title
Concomitant treatments (analgesics/NSAIDs)
Description
he use of analgesics or NSAIDs will be recorded throughout the study by direct questioning of the patient and/or through their medical records.
Time Frame
up to 6 months
Title
Change from The Oswestry Disability Index (ODI) at 1 month
Description
The Oswestry Disability Index (ODI) is a validated questionnaire (Fairbank and Pynsent 2000). We will consider a patient as responder if he/she manages to achieve at least 30% improvement in ODI score between baseline and 1 month. This percentage of minimal improvement (30%) was judged to be a clinically relevant threshold by an international consensus conference (Ostelo et al. 2008).
Time Frame
1 month after intervention
Title
Change from Baseline Pain using the Visual Analogue Scale (VAS) at 7 days
Description
VAS pain is a subjective but simple and reproducible criterion and one of the most widely used to evaluate the effectiveness of a therapeutic strategy in chronic low back pain. 0 represents no pain and 100 represents the worst pain imaginable.
Time Frame
7 days after intervention
Title
Change from Baseline Pain using the Visual Analogue Scale (VAS) at 3 months
Description
VAS pain is a subjective but simple and reproducible criterion and one of the most widely used to evaluate the effectiveness of a therapeutic strategy in chronic low back pain. 0 represents no pain and 100 represents the worst pain imaginable.
Time Frame
3 months after intervention
Title
Change from Baseline Pain using the Visual Analogue Scale (VAS) at 6 months
Description
VAS pain is a subjective but simple and reproducible criterion and one of the most widely used to evaluate the effectiveness of a therapeutic strategy in chronic low back pain. 0 represents no pain and 100 represents the worst pain imaginable.
Time Frame
6 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient 18 years of age or older Patient with Modic I lateralized disc disease seen on an MRI less than 6 months old. Chronic medial or lateralized (same side as MODIC 1) low back pain for at least 3 months with a mean pain intensity ≥ 40/100 mm on a VAS. Effective contraception for women of childbearing age, at least 6 months after injection (surgical sterilisation, approved hormonal contraceptives, barrier methods, intrauterine intrauterine device) Exclusion Criteria: Patient with MODIC 1 in both underlying and overlying vertebral spaces. Patient with an inflammatory signal abnormality of the vertebral body plateau related to non-mechanical pathology (e.g. spondyloarthritis). Patients with a history of lumbar spine surgery. Patient with suspected spondylodiscitis or other infection. Patients on anticoagulant or antiaggregant therapy, or with a coagulation disorder. Patients with an allergy to iodine or to any of the components of Xylocaine. Patients with an allergy to prednisolone or to any component of Hydrocortancyl® or Dexamethasone®.. Patient with severe uncontrolled disease (i.e. cardiac gastrointestinal, neurological, endocrine, autoimmune) that limits patient safety (as determined by the safety (as judged by the investigator). Prior to the treatment visit : current and recent morphine use (< 1 month) recent systemic or local corticosteroid therapy (< 1 month). Patient with sphincter disturbances indicative of cauda equina syndrome. Psychotic state not controlled by treatment Pregnancy (βHCG positive), breastfeeding Vulnerable patient protected by law Patient under guardianship or curatorship Patient participating in an interventional study Patient unable to read and/or write
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arthur HAMEL SENECAL, MD
Phone
0467338946
Ext
+33
Email
arthur.hamelsenecal@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine CYTEVAL, MD, PhD
Ext
+33
Email
c-cyteval@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur HAMEL-SENECAL, MD
Organizational Affiliation
Departement of Medical Imaging - Montpellier University hospital LAPEYRONIE Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Medical Imaging
City
Montpellier
State/Province
Occitanie
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celine ENGRAND
Email
c-engrand@chu-montpellier.fr

12. IPD Sharing Statement

Learn more about this trial

Evaluating the Efficacy of Para-discal Infiltration in Patients With Lateralized MODIC 1 Inflammatory Disc Disease

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