Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

NCT03415828 | Recruiting

• 1 other identifier: 2017-A03259-44
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 5

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.

Conditions

Lumbar Discogenic Pain (Disorder)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Long-term efficacy profile

  Month 12

• Long-term efficacy profile

  Month 24

• Short-term safety profile

  Month 3

• Long-term safety profile

  Month 12

• Long-term safety profile

  Month 24

Study Arms (2)

Ethanol gel

EXPERIMENTAL

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

Steroid infiltration

ACTIVE COMPARATOR

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

Interventions

Ethanol gel DEVICE

Intradiscal injection of ethanol gel

Also known as: DISCOGEL®

Ethanol gel

Prednisolone acetate DRUG

Intradiscal infiltration of steroids

Also known as: HYDROCORTANCYL 2,5 POUR CENT

Steroid infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient 18 years of age or older;
• 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.

You may not qualify if:

• 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;
• Subject who has forfeited their freedom by administrative or legal award, or is under guardianship or under limited judicial protection

Sponsors & Collaborators

• Gelscom SAS: lead
• CEISO: collaborator

Study Sites (5)

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

MeSH Terms

Interventions

prednisolone acetate

Study Officials

• Mathieu de Sèze, Dr

  CHU Bordeaux Pellegrin

  STUDY CHAIR

Central Study Contacts

Mathieu De Sèze, Dr

CONTACT

+335 56 79 55 16; corinne.pallas@chu-bordeaux.fr

Camélia Bentaleb

CONTACT

camelia.bentaleb@ceiso.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 30, 2018
• Study Start: May 29, 2018
• Primary Completion: February 29, 2024
• Study Completion (Estimated): May 29, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)