Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain
- Conditions
- Lumbar Discogenic Pain (Disorder)
- Registration Number
- NCT03415828
- Lead Sponsor
- Gelscom SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 83
Inclusion Criteria:<br><br> - Patient 18 years of age or older;<br><br> - 2-month refractory pain to conservative treatment, non-surgical patients;<br><br> - Chronic discogenic pain (1 or 2 lumbar discs) with concordant MR imaging;<br><br> - Symptomatic for at least 8 weeks despite appropriate medical treatment;<br><br> - Patient who agrees to participate in the study and who signed the informed consent<br> form;<br><br> - Patient with social protection.<br><br>Exclusion Criteria:<br><br> - Previous surgical treatment of the studied disc(s);<br><br> - Patient with pure radicular pain;<br><br> - Sick leave of more than 12 months secondary to the symptoms;<br><br> - Patients who cannot read or write French;<br><br> - History of cognitive-behavioral disorders that could interact with assessment by<br> self-questionnaire;<br><br> - Local or general infection, or suspicion of infection;<br><br> - Severe coagulation disorders;<br><br> - Other rheumatic inflammatory disease;<br><br> - Undercurrent serious pathology with life expectancy < 2 years;<br><br> - Female of childbearing age that are known to be pregnant during inclusion visit or<br> wishing to become pregnant before treatment;<br><br> - Subject who has forfeited their freedom by administrative or legal award, or is<br> under guardianship or under limited judicial protection<br><br> - Patient participating in another interventional clinical trial or testing an<br> experimental drug within 30 days of inclusion in the study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Short-term efficacy profile
- Secondary Outcome Measures
Name Time Method Long-term efficacy profile;Long-term efficacy profile;Short-term safety profile;Long-term safety profile;Long-term safety profile;Questionnaire OSWESTRY;Questionnaire MacNab;Radiography;Radiography;Radiography;Magnetic Resonance Imaging;Procedures costs;Procedures durations