Clinical trial NCT03415828: Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain
Official title: Intradiscal Gelified Ethanol Versus Intradiscal Steroid in Refractory Lumbar Discogenic Pain: a Randomized Single-blind Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Discogenic Pain (Disorder)
Lead sponsor: Gelscom SAS
Sponsor class: INDUSTRY
Collaborators: name: CEISO
First posted: 2018-01-30
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 2016. Clinical data on more than 600 patients treated by DISCOGEL® were analyzed. These data should be confirmed by monitoring on the long term, with a large cohort of patients, over a two-year follow-up period.

As part of the post-CE surveillance, the manufacturer GELSCOM is responsible of this "Post-Market Clinical Follow-up" (PMCF) study in accordance with Directive 93/42/EEC and MEDDEV guide 2.12/2, to assess the efficacy and the long-term safety of DISCOGEL®.

The study is comparative. The results will evaluate the performance and safety of the CE-marked medical device used in "real life", in comparison with a steroid infiltration, used according to its indication and to the current standards. It will include economic data. Patients and evaluators will be blinded. Both DISCOGEL® and HYDROCORTANCYL 2,5 POUR CENT are authorized products used according to their intended use.

This is an interventional, prospective, national, multi-center, comparative, randomized, single-blind (patient and evaluator) post-market clinical study. The primary objective is to compare the short-term efficacy profile of DISCOGEL® versus intradiscal steroid.


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.

Primary outcomes:
measure: Short-term efficacy profile
timeFrame: Month 3
Secondary outcomes:
measure: Long-term efficacy profile
timeFrame: Month 12
measure: Long-term efficacy profile
timeFrame: Month 24
measure: Short-term safety profile
timeFrame: Month 3
measure: Long-term safety profile
timeFrame: Month 12
measure: Long-term safety profile
timeFrame: Month 24
measure: Questionnaire OSWESTRY
timeFrame: Month 24
measure: Questionnaire MacNab
timeFrame: Month 24
measure: Radiography
timeFrame: Month 3
measure: Radiography
timeFrame: Month 12
measure: Radiography
timeFrame: Month 24
measure: Magnetic Resonance Imaging
timeFrame: Month 3
measure: Procedures costs
timeFrame: Day 0
measure: Procedures durations
timeFrame: Day 0
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hospital Pellegrin
city: Saint-Pierre
country: France
facility: Hospital SUD La Reunion
city: Saint-Priest-en-Jarez
country: France
facility: Hospital St-Etienne
city: St-Dié-des-Vosges
country: France
facility: Hospital St-Dié-des-Vosges
city: Valence
country: France
facility: Hospital Valence
Study officials:
affiliation: CHU Bordeaux Pellegrin
name: Mathieu de Sèze, Dr
role: STUDY_CHAIR
References: