Evaluation of Efficacy and Safety of Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intradiscal Gelified Ethanol (Discogel).
- Who it may be relevant to
- Registry conditions: Pain, Cervical, Discogenic Pain. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain : a Interventional, Prospective, Multi-center, Open-label Study.
Overview
The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain.
Detailed description
After being informed about the study and potential tisks, all patients giving written informed consent will undergo a inclusion visit (CT scan and X ray at least) for study entry. At Day 0, operation with Intradiscal Gelified Ethanol will be performed by the investigator. Follow visit will be performed at 3 months and 12 months
Interventions
- Device Intradiscal Gelified Ethanol (Discogel)
Intradiscal percutaneous injection of an intradiscal Gelified Ethanol
Primary outcome measures
- the mean change in pain intensity assessed by a verbal local rating scale (pain intensity numerical scale) between the pre-treatment measurement (inclusion visi) and the post-treatment measurement (Visit 2 at the 3 months) [Time frame: 3 months]
Secondary outcome measures (5)
- Change in pain cervical intensity using the verbal local rating scale [ [Time frame: 12 months]
- Change of consumption of painkillers [Time frame: 12 months]
- Incidence of complication and adverse event rates [Time frame: 12 months]
- Change in ability to manage everyday-life activity (Neck Disability Index (NDI) scale) [Time Frame : inclusion, 3 and 12 months after treatment]. [Time frame: 12 months]
- Subjective evaluation MacNab [Time frame: 12 months after treatment]
Eligibility criteria
Inclusion criteria
- Patient 18 years or older;
- Pain refractory to conservative treatments for more than 2 months, non-surgical patients
- Cervicobrachialgia due to disc herniation
- Chronic discogenic pain (1 or 2 cervical discs) with concordant MRI;
- Patient agreeing to participate in the study and having given written consent;
- Patient enrolled in a health insurance plan.
Exclusion criteria
- Prior surgical treatment of the disc(s) studied;
- Sick leave of more than 12 months secondary to painful symptoms;
- Patient with Modic 1 score or more
- History of cognitive-behavioral disorders that could affect the completion of self-questionnaires;
- Local or systemic infection, or suspicion of infection;
- Severe coagulation disorders;
- Other inflammatory rheumatic disease;
- Severe underlying pathology with life expectancy <1 year;
- Women of childbearing age who are pregnant at the inclusion visit or who wish to become pregnant before the administration of the treatment (V0);
- Known allergy to contrast material and/or local anesthetic substances;
- Patients who cannot read or write Italian;
- Major person benefiting from a legal protection regime (guardianship, curatorship, safeguard of justice);
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 2 centers
- Santissima Trinità Hospital Ascagliari — Cagliari
- Azienda Ospedaliera Universitaria — Siena
Identifiers
NCT: NCT05969392 · CLI01068