An interventional study of Para-discal injection of corticoid in Degenerative Disc Disease, Inflammation and Low Back Pain, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Treatment
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.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 256 interventional studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
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Exclusion Criteria:
Prior to the treatment visit :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single arm study
Procedure: Para-discal injection of corticoid
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.
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.
Time frame: 1 month after intervention
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after intervention
Started Dec 2022 (actual). Primary completion is estimated for Jul 2025, 31 months after the start.
Of 40 non-industry interventional studies with no phase under Intervertebral Disc Degeneration, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 63. This study's planned 31 months is below that.
Counting every sponsor, half of 85 studies reached it within 50 months; a quarter within 27 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
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