Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

Not Applicable

Recruiting

• Conditions: Lumbar Discogenic Pain (Disorder)
• Interventions: Device: Ethanol gel; Drug: Prednisolone acetate

• Registration Number: NCT03415828
• Lead Sponsor: Gelscom SAS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-30
• Study Start: 2018-05-29
• Primary Completion: 2024-02-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13
• Study Completion: 2027-05-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 230

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ethanol gel	Ethanol gel	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
Steroid infiltration	Prednisolone acetate	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

Primary Outcome Measures

Name	Time	Method
Short-term efficacy profile	Month 3	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)

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Hospital Pellegrin; 🇫🇷 Bordeaux, France

Hospital SUD La Reunion; 🇫🇷 Saint-Pierre, France

Hospital St-Etienne; 🇫🇷 Saint-Priest-en-Jarez, France

Hospital St-Dié-des-Vosges; 🇫🇷 St-Dié-des-Vosges, France

Hospital Valence; 🇫🇷 Valence, France