Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

Launched by GELSCOM SAS · Jan 23, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a treatment called DISCOGEL® compared to a steroid injection for patients suffering from chronic lower back pain caused by disc issues, known as lumbar discogenic pain. The trial aims to see how well DISCOGEL® works in real-life situations, especially for patients who have not found relief from standard treatments. To be eligible, participants must be at least 18 years old, have experienced persistent pain for at least two months despite other treatments, and have specific findings in their MRI scans that confirm their condition.

Patients who join the study can expect to receive either DISCOGEL® or the steroid treatment, and their experience will be monitored for effectiveness and safety over time. Importantly, both the patients and the evaluators will be unaware of which treatment they receive, ensuring a fair comparison. This trial is crucial as it will help gather more information about how DISCOGEL® performs in a larger group of patients and contribute to our understanding of effective pain management for chronic back pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient 18 years of age or older;
• • 2-month refractory pain to conservative treatment, non-surgical patients;
• • Chronic discogenic pain (1 or 2 lumbar discs) with concordant MR imaging;
• • Symptomatic for at least 8 weeks despite appropriate medical treatment;
• • Patient who agrees to participate in the study and who signed the informed consent form;
• • Patient with social protection.
• Exclusion Criteria:
• • Previous surgical treatment of the studied disc(s);
• • Patient with pure radicular pain;
• • Sick leave of more than 12 months secondary to the symptoms;
• • Patients who cannot read or write French;
• • History of cognitive-behavioral disorders that could interact with assessment by self-questionnaire;
• • Local or general infection, or suspicion of infection;
• • Severe coagulation disorders;
• • Other rheumatic inflammatory disease;
• • Undercurrent serious pathology with life expectancy \< 2 years;
• • Female of childbearing age that are known to be pregnant during inclusion visit or wishing to become pregnant before treatment;
• • Subject who has forfeited their freedom by administrative or legal award, or is under guardianship or under limited judicial protection
• • Patient participating in another interventional clinical trial or testing an experimental drug within 30 days of inclusion in the study.