Degenerative Disc DiseaseIPADNCT05615597
Evaluating the Efficacy of Para-discal Infiltration in Patients With Lateralized MODIC 1 Inflammatory Disc Disease
A study testing Para-discal injection of corticoid in people with Degenerative Disc Disease and Inflammation, run by University Hospital, Montpellier at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Inflammation, Low Back Pain
- What is being tested?
- Para-discal injection of corticoid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2022to 22 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Catherine CYTEVAL, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
Departement of Medical Imaging
Montpellier, Occitanie, 34295
Celine ENGRAND, c-engrand@chu-montpellier.fr
About this study
Official title: Evaluating the Efficacy of Para-discal Infiltration in Patients With Lateralized MODIC 1 Inflammatory Disc Disease: Pilot Study (IPAD)
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.
Read more
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.
- Conditions
- Degenerative Disc Disease, Inflammation, Low Back Pain
- Being tested
- Para-discal injection of corticoid
- Keywords
- Low back pain, Injections, Degenerative Disc Disease, Inflammation
- Medical subject headings
- Intervertebral Disc Degeneration, Inflammation, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Para-discal injection of corticoidProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Para-discal infiltration | Other | Single arm study Receives: Procedure: Para-discal injection of corticoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after intervention
Secondary outcomes (5)
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.
Measured: up to 6 months
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).
Measured: 1 month after intervention
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.
Measured: 7 days after intervention
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.
Measured: 3 months after intervention
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.
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start22 Dec 2022
- Primary completion22 Jul 2025 (estimated)
- Study completion22 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur HAMEL-SENECAL, MD, Principal investigator, Departement of Medical Imaging - Montpellier University hospital LAPEYRONIE Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615597
- Sponsor's protocol ID
- RECHMPL22_0230
- Acronym
- IPAD
- Status last verified
- May 2024
- First submitted
- 27 Oct 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Para-discal Infiltration in Patients With Lateralized MODIC 1 Inflammatory Disc Disease: Pilot Study (IPAD)
- ClinicalTrials.gov ID
- NCT05615597
- Acronym / sponsor ID
- IPAD / RECHMPL22_0230
- Conditions
- Degenerative Disc Disease, Inflammation, Low Back Pain
- Keywords
- Low back pain, Injections, Degenerative Disc Disease, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 22 Jul 2025 (estimated)
- Study completion
- 22 Dec 2025 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Para-discal infiltration | Other | Procedure: Para-discal injection of corticoidSingle arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Para-discal injection of corticoidIn 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. | Procedure or surgery | Para-discal infiltration |
Primary outcome
Change from Baseline pain using the Visual Analogue Scale (VAS) at 1 month
Time frame: 1 month after intervention
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.
5 secondary outcomes
Concomitant treatments (analgesics/NSAIDs)
Time frame: up to 6 months
Change from The Oswestry Disability Index (ODI) at 1 month
Time frame: 1 month after intervention
Change from Baseline Pain using the Visual Analogue Scale (VAS) at 7 days
Time frame: 7 days after intervention
Change from Baseline Pain using the Visual Analogue Scale (VAS) at 3 months
Time frame: 3 months after intervention
Change from Baseline Pain using the Visual Analogue Scale (VAS) at 6 months
Time frame: 6 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine CYTEVAL, MD, PhD contact
Arthur HAMEL-SENECAL, MD principal investigator
Departement of Medical Imaging - Montpellier University hospital LAPEYRONIE Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Para-discal injection of corticoid in people with Degenerative Disc Disease and Inflammation, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arthur HAMEL SENECAL, MD (0467338946 ext. +33, arthur.hamelsenecal@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline pain using the Visual Analogue Scale (VAS) at 1 month (time frame: 1 month after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.