Comparing Ethanol Gel and Steroid for Chronic Lower Back Pain

Intradiscal Gelified Ethanol Versus Intradiscal Steroid in Refractory Lumbar Discogenic Pain: a Randomized Single-blind Study

This study tests whether an ethanol gel can help people with chronic lower back pain feel better compared to steroid injections.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 230 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Gelscom SAS (industry)
• Locations: 5 sites (Bordeaux and 4 other locations)
• Trial ID: NCT03415828 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of DISCOGEL®, an ethanol gel, compared to steroid injections for patients suffering from refractory lumbar discogenic pain. The study involves a long-term follow-up of patients who have not responded to conservative treatments for at least two months. Participants will be monitored over a two-year period to assess pain relief and overall outcomes, with both patients and evaluators blinded to the treatment received. Economic data will also be collected to evaluate the cost-effectiveness of the interventions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic discogenic pain that has not improved with conservative treatment for at least two months.

Not a fit: Patients who have undergone previous surgical treatment for their disc pain or those with pure radicular pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, effective treatment option for patients with chronic lower back pain who have not benefited from traditional therapies.

How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison of ethanol gel and steroid injections is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Bordeaux and 4 other locations

• Hospital Pellegrin — Bordeaux, France (RECRUITING)
• Hospital St-Dié-des-Vosges — Saint-Dié, France (TERMINATED)
• Hospital SUD La Reunion — Saint-Pierre, France (RECRUITING)
• Hospital St-Etienne — Saint-Priest-en-Jarez, France (RECRUITING)
• Hospital Valence — Valence, France (TERMINATED)

Study contacts

• Study coordinator: Mathieu De Sèze, Dr

Conditions: Lumbar Discogenic Pain