Intradiscal Gelified Ethanol (Discogel)
DeviceIntradiscal percutaneous injection of an intradiscal Gelified Ethanol
NCT Number: NCT05969392
The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain.
Trial opening soon.
Get Notified18 year–120 year
All sexes
Interventional
Phase 2 / Phase 3
Santissima Trinità Hospital Ascagliari, Cagliari, Italy
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intradiscal percutaneous injection of an intradiscal Gelified Ethanol
Time frame: 3 months
In a 11-point numeric scale, 0 represents "NO PAIN" and 10 represents "EXTREME PAIN" (e.g., "pain as bad as you can imagine" and "worst pain imaginable").
Time frame: 12 months
Scores range from 0-10. In a 11-point numeric scale, 0 represents "NO PAIN" and 10 represents "EXTREME PAIN" (e.g., "pain as bad as you can imagine" and "worst pain imaginable").
Time frame: 12 months
Number, frequency and dosage of pain relief treatments will be combine todescribe the difference in painkiller consumption before and after the operation
Time frame: 12 months
Incidence of adverse event during 12 months after the treatment
Time frame: 12 months
The Neck Disability Index (NDI) is used to measure pain-related disability associated with activities of daily living in people with neck pain (index between 0 and 50). The original report provided scoring intervals for interpretation, as follows: 0 - 4 = no disability, 5 - 14 = mild, 15 - 24 = moderate, 25 - 34 = severe, above 34 = complete. The NDI contains 10 items-7 related to activities of daily living, 2 related to pain, and 1 related to concentration.
Time frame: 12 months after treatment
The MacNab's scale is layered into 4 levels (excellent, good, fair and poor) according to the patient's well-being after surgery or procedure.The scores were divided into the following four grades: 75-100% (excellent), 50-74% (good), 25-49% (fair) and 0-24% (poor). "Excellent" is defined as "No pain; no restriction of activity". "Good" is defined as "Occasional pain of sufficient severity to interfere with the patient's ability to do his normal work or his capacity to enjoy himself in leisure hours".
Gelscom SAS
Industry
Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain : a Interventional, Prospective, Multi-center, Open-label Study.
Acronym: DISCOCERV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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