Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Lumbar Discogenic Pain (Disorder)

Intervention / Treatment
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* Device: Ethanol gel
* Drug: Prednisolone acetate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ethanol gel<br>CE-marked medical device used according to its instructions for use: GELSCOM® Single injection in the selected disc(s) of 0.6 to 2.2 ml | Device: Ethanol gel<br>* Intradiscal injection of ethanol gel<br>* Other names: DISCOGEL®;|
| Active Comparator: Steroid infiltration<br>Authorized drug used according to its summary product characteristics: HYDROCORTANCYL 2,5 POUR CENT Single injection in the selected disc(s) of 0.2 to 2.0 ml | Drug: Prednisolone acetate<br>* Intradiscal infiltration of steroids<br>* Other names: HYDROCORTANCYL 2,5 POUR CENT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term efficacy profile | Compare the short-term efficacy profile of DISCOGEL® versus intradiscal steroid: percentage of patients with a pain relief defined by a Low Back Pain (LBP) intensity<4 cm on a Local Verbal Rating Scale (0 = no pain to 10 = maximum imaginable pain) | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term efficacy profile | Compare the long-term efficacy profile of DISCOGEL® versus intradiscal steroid: Local Verbal Rating Scale: on back, bottom, thigh, leg, foot | Month 12 | 
| Long-term efficacy profile | Compare the long-term efficacy profile of DISCOGEL® versus intradiscal steroid: Local Verbal Rating Scale: on back, bottom, thigh, leg, foot | Month 24 | 
| Short-term safety profile | Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions | Month 3 | 
| Long-term safety profile | Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions | Month 12 | 
| Long-term safety profile | Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions | Month 24 | 
| Questionnaire OSWESTRY | Describe the rate of subjects improved 24 months after treatment: OSWESTRY scale | Month 24 | 
| Questionnaire MacNab | Subjective improvement 24 months after treatment: MacNab scale | Month 24 | 
| Radiography | Describe radiologic evolution of the lesions: radiography of the herniated disc | Month 3 | 
| Radiography | Describe radiologic evolution of the lesions: radiography of the herniated disc | Month 12 | 
| Radiography | Describe radiologic evolution of the lesions: radiography of the herniated disc | Month 24 | 
| Magnetic Resonance Imaging | Describe radiologic evolution of the lesions: MRI of the herniated disc | Month 3 | 
| Procedures costs | Compare the cost linked to the DISCOGEL® procedure and the cost linked to a steroid infiltration or surgery | Day 0 | 
| Procedures durations | Compare the duration of the treatment procedures between a DISCOGEL® injection and a steroid infiltration or surgery | Day 0 |