Advancements in health research.
Clinically meaningful pain reduction and functional recovery after percutaneous intradiscal treatment for cervical disc herniation: Interim results of the genesis study
By Pain Therapy Unit.
Abstract
Background. Chronic cervical pain due to disc herniation is a clinically significant condition frequently refractory to conservative treatment. In patients with persistent pain, minimally invasive intradiscal procedures may represent an alternative to surgery. Published evidence on radiopaque gelified ethanol in cervical disc herniation remains limited, particularly regarding real-world outcomes and long-term clinical benefit (1,2). The GENESIS study assessed the clinical outcomes and safety of percutaneous intradiscal radiopaque gelified ethanol under real-world clinical practice.Methods. GENESIS is a single-centre, investigator-initiated, non-profit observational study with a retro-prospective design conducted at the Pain Therapy Unit, Vimercate Hospital (ASST Brianza). Adults aged 18–75 years with MRI-confirmed symptomatic cervical disc herniation and baseline VAS >4 were included. Treatment followed routine clinical practice using an anterolateral approach under fluoroscopic guidance and local anaesthesia. The primary endpoint was the proportion of patients achieving ≥30% VAS reduction at 1 month. Secondary endpoints included VAS at 3 and 12 months, PGIC, functional recovery, surgical re-intervention, and safety. This interim analysis includes 31 enrolled patients, 22 with complete 12-month follow-up.Results. Baseline mean VAS was 8.5 ± 0.6. Pain decreased to 4.8 ± 0.9 at 1 month (−44%), 2.9 ± 1.1 at 3 months (−66%), and 2.4 ± 0.7 at 12 months (−72%), exceeding accepted minimal clinically important difference thresholds throughout follow-up (3). Mean PGIC improved to 2.0 ± 0.6 at 12 months ("much improved"). At 3 months, 90% of patients showed improved cervical muscle function and 95% resumed normal daily activities. Technical success was achieved in all procedures. No surgical re-interventions, serious adverse events, device- or procedure-related adverse events, neurological complications, or unexpected safety signals were observed during follow-up.Conclusions. This interim analysis suggests that percutaneous intradiscal radiopaque gelified ethanol is associated with early, clinically meaningful and sustained pain reduction, improved patient-reported outcomes and functional recovery, with no safety concerns identified during follow-up. Continued enrolment and longer follow-up will further define the durability of benefit and the role of this procedure in chronic cervical discogenic pain.



