Back Pain Lower Back ChronicPhase 4PREDIDNCT00804531
Intra-discal Steroid Injection for MODIC I Discopathy
A Phase 4 study testing Visipaque - Hydrocortancyl in people with Back Pain Lower Back Chronic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To assess the efficacy on pain level at 1 month and 12 months of a steroid injection in the inter-vertebral disc for patients with chronic back pain and inflammatory discopathy on magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- Visipaque - Hydrocortancyl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Nov 2015
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 18 and less than 70 years old
- Low back pain
- Daily pain for at least 3 months
- Pain level during the last 48 hours > 40 on the numeric pain scale (0-100)
- Lack of efficacy of usual recommended treatments and of other spine steroid injections (epidural or facet joints injections)
- Modic I discopathy on MRI
Show all 25Show fewer
- Intra-discal injection at least 6 months before inclusion
- Written informed consent
- Social security
- Medical examination
- Non inclusion criteria :
- Pregnancy
- Hypersensitivity to methylprednisolone or contrast
- Local or general infection
- Previous disc surgery less than 6 months
- Steroid treatment
- Previous infectious spondylodiscitis
- Ankylosing spondylitis
- Sciatica with neurologic defects
- Uncontrolled psychiatric conditions
- Inability to read or understand French language
- Anti-vitamin K treatments
- Severe coagulation diseases
- Fever > 38 or sedimentation rate > 20
- Discopathy with MODIC 1 signal on several different lumbar stages
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial
To assess the efficacy on pain level at 1 month and 12 months of a steroid injection in the inter-vertebral disc for patients with chronic back pain and inflammatory discopathy on magnetic resonance imaging.
Hypothesis: delivering anti-inflammatory drugs in situ may decrease back pain in patients with inflammatory discopathy
Read the detailed description
Objective: to assess the efficacy on pain level of a steroid injection in the inter-vertebral disc for patients with chronic back pain and MODIC I discopathy on MRI
Methods: a multicenter double blind randomized control trial Setting: 3 tertiary care hospitals in France Patients: 134 patients with disabling chronic low back pain not relieved by usual recommended treatments and MODIC I (inflammatory) discopathy on MRI Intervention: Injection of 25 mg of methylprednisolone in the inter-vertebral disc during a discography (intervention group, 67 patients) or discography alone (control group, 67 patients) Outcome measures: The primary outcome measure is pain level assessed on a 11-point numeric scale (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month. Secondary outcome measures are pain level at 12 months, Disability (Quebec questionnaire), quality of life (SF-12) at 1 and 12 months, anxiety and depression (HAD), analgesics and anti-inflammatories during the last week, return to work, assessment of the disabilities at 1 and 12 months and disc inflammation (on MRI) at 12 months. Tolerance and adverse effects will be recorded.
Trial duration: 36 months(24 months for inclusion and 12 months follow-up) Follow-up visits: at 1, 3, 6, and 12 months Statistical analysis: intention to treat
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- Visipaque - Hydrocortancyl, Placebo comparator
- Keywords
- Low back pain, steroid injection, inter-vertebral disc, randomized trial, Lack of efficacy of usual recommended treatments, More than 40 on the pain numeric scale (0-100), Inflammatory discopathy (MODIC I) on MRI
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visipaque - HydrocortancylDrug
Visipaque 320 mg I/ml - 1 ml intra-discal route Hydrocortancyl 25 mg/ml - 1 ml intra-discal route
Placebo comparatorDrug
Visipaque - 320 mg I/ml - 1 ml in intra-discal route
| Study group | Role | What they receive |
|---|---|---|
| Visipaque - Hydrocortancyl | Experimental | Administration of two treatments for the experimental arm Receives: Drug: Visipaque - Hydrocortancyl |
| Visipaque | Placebo comparator | Administration of only one treatment in intra discal of visipaque Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Back pain level assessed on a 11-point numeric scale (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month
Measured: 1 month
Secondary outcomes (8)
pain level at 12 months
Measured: 12 months
Disability (Quebec questionnaire)
Measured: 1 month and 12 months
quality of life (SF-12) at 1 and 12 months
Measured: 1 month and 12 months
anxiety and depression (HAD)
Measured: 1 month and 12 months
disc inflammation (on MRI) at 12 month
Measured: 12 months
analgesics and anti-inflammatories during the last week
Measured: 1 month and 12 months
return to work
Measured: 1 month and 12 months
Assessment of the disabilities (scale of 6 classes)
Measured: 1 month and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startApr 2009
- Primary completionMay 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Serge Poiraudeau, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804531
- Sponsor's protocol ID
- P070157
- Acronym
- PREDID
- Status last verified
- Sep 2025
- First submitted
- 8 Dec 2008
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Nguyen C, Boutron I, Baron G, Sanchez K, Palazzo C, Benchimol R, Paris G, James-Belin E, Lefevre-Colau MM, Beaudreuil J, Laredo JD, Bera-Louville A, Cotten A, Drape JL, Feydy A, Ravaud P, Rannou F, Poiraudeau S. Intradiscal Glucocorticoid Injection for Patients With Chronic Low Back Pain Associated With Active Discopathy: A Randomized Trial. Ann Intern Med. 2017 Apr 18;166(8):547-556. doi: 10.7326/M16-1700. Epub 2017 Mar 21.
PubMed 28319997Daste C, Abdoul H, Foissac F, Lefevre-Colau MM, Poiraudeau S, Rannou F, Nguyen C. Patient acceptable symptom state for patient-reported outcomes in people with non-specific chronic low back pain. Ann Phys Rehabil Med. 2022 Jan;65(1):101451. doi: 10.1016/j.rehab.2020.10.005. Epub 2020 Nov 26.
PubMed 33152522
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00804531
- Acronym / sponsor ID
- PREDID / P070157
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- Low back pain, steroid injection, inter-vertebral disc, randomized trial, Lack of efficacy of usual recommended treatments, More than 40 on the pain numeric scale (0-100), Inflammatory discopathy (MODIC I) on MRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Apr 2009
- Primary completion
- May 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Dec 2008 (estimated)
- 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.
To assess the efficacy on pain level at 1 month and 12 months of a steroid injection in the inter-vertebral disc for patients with chronic back pain and inflammatory discopathy on magnetic resonance imaging.
Hypothesis: delivering anti-inflammatory drugs in situ may decrease back pain in patients with inflammatory discopathy
Detailed description
Objective: to assess the efficacy on pain level of a steroid injection in the inter-vertebral disc for patients with chronic back pain and MODIC I discopathy on MRI
Methods: a multicenter double blind randomized control trial Setting: 3 tertiary care hospitals in France Patients: 134 patients with disabling chronic low back pain not relieved by usual recommended treatments and MODIC I (inflammatory) discopathy on MRI Intervention: Injection of 25 mg of methylprednisolone in the inter-vertebral disc during a discography (intervention group, 67 patients) or discography alone (control group, 67 patients) Outcome measures: The primary outcome measure is pain level assessed on a 11-point numeric scale (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month. Secondary outcome measures are pain level at 12 months, Disability (Quebec questionnaire), quality of life (SF-12) at 1 and 12 months, anxiety and depression (HAD), analgesics and anti-inflammatories during the last week, return to work, assessment of the disabilities at 1 and 12 months and disc inflammation (on MRI) at 12 months. Tolerance and adverse effects will be recorded.
Trial duration: 36 months(24 months for inclusion and 12 months follow-up) Follow-up visits: at 1, 3, 6, and 12 months Statistical analysis: intention to treat
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visipaque - Hydrocortancyl | Experimental | Drug: Visipaque - HydrocortancylAdministration of two treatments for the experimental arm |
| Visipaque | Placebo comparator | Drug: Placebo comparatorAdministration of only one treatment in intra discal of visipaque |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- More than 18 and less than 70 years old
- Low back pain
- Daily pain for at least 3 months
- Pain level during the last 48 hours > 40 on the numeric pain scale (0-100)
- Lack of efficacy of usual recommended treatments and of other spine steroid injections (epidural or facet joints injections)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Visipaque - HydrocortancylVisipaque 320 mg I/ml - 1 ml intra-discal route Hydrocortancyl 25 mg/ml - 1 ml intra-discal route | Drug | Visipaque - Hydrocortancyl |
| Placebo comparatorVisipaque - 320 mg I/ml - 1 ml in intra-discal route | Drug | Visipaque |
Primary outcome
Back pain level assessed on a 11-point numeric scale (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month
Time frame: 1 month
8 secondary outcomes
pain level at 12 months
Time frame: 12 months
Disability (Quebec questionnaire)
Time frame: 1 month and 12 months
quality of life (SF-12) at 1 and 12 months
Time frame: 1 month and 12 months
anxiety and depression (HAD)
Time frame: 1 month and 12 months
disc inflammation (on MRI) at 12 month
Time frame: 12 months
analgesics and anti-inflammatories during the last week
Time frame: 1 month and 12 months
return to work
Time frame: 1 month and 12 months
Assessment of the disabilities (scale of 6 classes)
Time frame: 1 month and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 28319997Nguyen C, Boutron I, Baron G, Sanchez K, Palazzo C, Benchimol R, Paris G, James-Belin E, Lefevre-Colau MM, Beaudreuil J, Laredo JD, Bera-Louville A, Cotten A, Drape JL, Feydy A, Ravaud P, Rannou F, Poiraudeau S. Intradiscal Glucocorticoid Injection for Patients With Chronic Low Back Pain Associated With Active Discopathy: A Randomized Trial. Ann Intern Med. 2017 Apr 18;166(8):547-556. doi: 10.7326/M16-1700. Epub 2017 Mar 21.
- Derived from this study: PubMed 33152522Daste C, Abdoul H, Foissac F, Lefevre-Colau MM, Poiraudeau S, Rannou F, Nguyen C. Patient acceptable symptom state for patient-reported outcomes in people with non-specific chronic low back pain. Ann Phys Rehabil Med. 2022 Jan;65(1):101451. doi: 10.1016/j.rehab.2020.10.005. Epub 2020 Nov 26.
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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.
Serge Poiraudeau, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Visipaque - Hydrocortancyl in people with Back Pain Lower Back Chronic, run by Assistance Publique - Hôpitaux de Paris 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 25 inclusion and 0 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: finished, as of the sponsor's last update on 12 Sep 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back pain level assessed on a 11-point numeric scale (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00804531, which also lists 2 linked publications.
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 12 Sep 2025.