GENESIS is a single-centre, observational, non-interventional, no-profit, investigator-initiated study conducted at Ospedale di Vimercate, ASST Brianza (Italy).
The study describes the clinical and functional course of adult patients with cervical disc herniation and chronic discogenic neck pain who receive intradiscal radiopaque gelified ethanol (Absolute Gel), a CE-marked Class III medical device, as part of routine clinical practice and within its approved indications.
The study does not assign, introduce or modify any treatment, procedure, medication or follow-up schedule. The decision to treat is taken exclusively by the treating physician according to standard clinical practice. The study only collects clinical and radiological data generated during routine care, both retrospectively (patients already treated) and prospectively (patients treated independently of study participation).
Approximately 45 participants are planned. The main descriptive measure is the proportion of participants achieving a reduction of at least 30% in neck pain intensity (Visual Analogue Scale, VAS) at 1 month compared with baseline. Participants are followed up to 48 months after treatment.
All analyses are descriptive. The study is not designed to demonstrate efficacy, to support causal inference, or to perform comparisons with other treatments.
Male or female, aged 18 to 75 years, already treated with or candidate for Absolute Gel for cervical disc herniation as part of standard clinical practice
Signed informed consent to participate in the study (prospective participants; retrospective participants according to the conditions approved by the Ethics Committee)
Discogenic neck pain confirmed by a history of cervical neck pain, with at least 3 months of continuous pain or 6 months of acute recurrent episodes despite conservative treatment including analgesics and physiotherapy
Baseline neck pain intensity VAS greater than 4 out of 10
Active local or systemic infection (systemic or cervical)
Known contraindications to ethanol or to device components
Coagulopathy or anticoagulant therapy that cannot be discontinued according to clinical practice
Serious medical or systemic disease making the treatment inappropriate according to clinical judgement
Adults aged 18 to 75 years with MRI-confirmed cervical disc herniation and persistent discogenic neck pain not adequately controlled by conservative therapy, who have already been treated with, or are candidates for, intradiscal radiopaque gelified ethanol (Absolute Gel) as part of routine clinical practice at Ospedale di Vimercate, ASST Brianza. Participants are identified from the patient population of the investigator at the specialised pain management and interventional spine service. Both retrospectively and prospectively enrolled participants are included.
Cohort
Other
Absolute Gel (radiopaque gelified ethanol)
DeviceCE-marked Class III medical device used within its approved indications as part of standard clinical care. Intradiscal injection of radiopaque gelified ethanol at the cervical level, performed under fluoroscopic guidance through an antero-lateral approach with local anaesthesia, typically 0.3 to 0.4 mL per disc. The study does not assign, impose or modify the treatment, the technique or the peri-procedural management; it records the procedure as performed in routine practice.
Proportion of participants with a reduction of at least 30% in neck pain intensity (VAS) at 1 month
Neck pain intensity is measured with the Visual Analogue Scale (VAS), a 0 to 10 scale where 0 = no pain and 10 = worst imaginable pain. Lower scores indicate less pain. The measure is the proportion of participants whose VAS score at 1 month is reduced by at least 30% compared with baseline, reported with exact 95% binomial confidence intervals. Descriptive only; no hypothesis testing is performed.
Change from baseline in neck pain intensity (VAS) at 1 month
Continuous change from baseline in VAS score (0 to 10; lower scores indicate less pain), summarised with mean, standard deviation, median, interquartile range and range. Descriptive only.
Change from baseline in neck pain intensity (VAS) over time
VAS scores (0 to 10; lower scores indicate less pain) and changes from baseline at each scheduled follow-up, summarised descriptively.
Proportion of participants with a reduction of at least 50% in neck pain intensity (VAS)
Proportion of participants achieving a reduction of at least 50% in VAS score compared with baseline, reported descriptively as an indicator of a more pronounced clinical response.
Patient Global Impression of Change (PGIC)
Self-reported perception of overall change assessed with the PGIC scale (7 categories, from "very much improved" to "very much worse"; lower scores indicate greater perceived improvement). Reported as frequency distributions; the proportion of participants reporting "much improved" or "very much improved" may be reported with 95% confidence intervals, for descriptive purposes only.
Change from baseline in cervical function measured with the Copenhagen Neck Functional Disability Scale (CNFDS)
CNFDS is a validated 15-item questionnaire assessing neck-related functional disability, with a total score from 0 to 30; higher scores indicate greater disability. Changes from baseline are summarised descriptively.
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Aurel Mengri
Lead sponsor
ASST Brianza - Ospedale di Vimercate
Sponsor institution
