Status:
RECRUITING
Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain
Lead Sponsor:
Gelscom SAS
Collaborating Sponsors:
CEISO
Conditions:
Lumbar Discogenic Pain (Disorder)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
DISCOGEL® is on the market since 2007. About 20,000 kits were sold to date (October 2017). The device re-obtained its CE mark in 2017. A clinical evaluation was performed by bibliographic route in 20...
Eligibility Criteria
Inclusion
- Patient 18 years of age or older;
- 2-month refractory pain to conservative treatment, non-surgical patients;
- Chronic discogenic pain (1 or 2 lumbar discs) with concordant MR imaging;
- Symptomatic for at least 8 weeks despite appropriate medical treatment;
- Patient who agrees to participate in the study and who signed the informed consent form;
- Patient with social protection.
Exclusion
- Previous surgical treatment of the studied disc(s);
- Patient with pure radicular pain;
- Sick leave of more than 12 months secondary to the symptoms;
- Patients who cannot read or write French;
- History of cognitive-behavioral disorders that could interact with assessment by self-questionnaire;
- Local or general infection, or suspicion of infection;
- Severe coagulation disorders;
- Other rheumatic inflammatory disease;
- Undercurrent serious pathology with life expectancy \< 2 years;
- Female of childbearing age that are known to be pregnant during inclusion visit or wishing to become pregnant before treatment;
- Subject who has forfeited their freedom by administrative or legal award, or is under guardianship or under limited judicial protection
- Patient participating in another interventional clinical trial or testing an experimental drug within 30 days of inclusion in the study.
Key Trial Info
Start Date :
May 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 29 2027
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT03415828
Start Date
May 29 2018
End Date
May 29 2027
Last Update
September 29 2025
Active Locations (5)
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1
Hospital Pellegrin
Bordeaux, France
2
Hospital St-Dié-des-Vosges
Saint-Dié, France
3
Hospital SUD La Reunion
Saint-Pierre, France
4
Hospital St-Etienne
Saint-Priest-en-Jarez, France