Comparing Intradiscal Ethanol Gel and Steroid Injection for Treating Persistent Lumbar Discogenic Pain in Adults

What this Trial Is About

Researchers are evaluating the long-term safety and effectiveness of DISCOGEL4, a gelified ethanol device, compared with intradiscal steroid infiltration for treating refractory lumbar discogenic pain. This study is designed as a randomized, prospective, single-blind clinical trial involving patients who have chronic discogenic pain not responding to conservative treatments. The trial aims to confirm previous clinical data from over 600 patients by monitoring a larger group over two years. Participants will be randomly assigned to receive either a single intradiscal injection of DISCOGEL4 0.6 to 2.2 ml or a single injection of the authorized steroid drug Hydrocortancyl 2.5% 0.2 to 2.0 ml. Both treatments are used according to their approved instructions. The study includes a comparison of short-term efficacy at 3 months and long-term efficacy and safety up to 24 months. Economic data and procedure durations will also be collected. During the study, participants will undergo various assessments including questionnaires Oswestry and MacNab, radiography, and magnetic resonance imaging at multiple time points 3, 12, and 24 months. Researchers will monitor both short-term and long-term safety and efficacy, as well as procedure-related factors. The total follow-up period extends to two years, ensuring comprehensive evaluation of treatment effects and participant well-being throughout the study.

Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain