Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain (IDIS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Discogenic Pain (Disorder)
• Intervention / Treatment: Device: Ethanol gel; Drug: Prednisolone acetate

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mathieu De Sèze, Dr; Phone Number: +335 56 79 55 16; Email: corinne.pallas@chu-bordeaux.fr
• Study Contact Backup: Name: Camélia Bentaleb; Email: camelia.bentaleb@ceiso.fr

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • Hospital Pellegrin
    • Contact: Mathieu de Sèze, Pr.
  • Saint-Dié, France
    • Terminated
    • Hospital St-Dié-des-Vosges
  • Saint-Pierre, France
    • Recruiting
    • Hospital SUD La Reunion
    • Contact: Romain Kohlmann, Dr.
  • Saint-Priest-en-Jarez, France
    • Recruiting
    • Hospital St-Etienne
    • Contact: Sylvain Grange, Dr.
  • Valence, France
    • Terminated
    • Hospital Valence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Ethanol gel; Intradiscal injection of ethanol gel; Other Names: DISCOGEL®
Active Comparator: Steroid infiltration; 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; Intradiscal infiltration of steroids; Other Names: HYDROCORTANCYL 2,5 POUR CENT

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gelscom SAS
• Collaborators: CEISO
• Investigators: Study Chair: Mathieu de Sèze, Dr, CHU Bordeaux Pellegrin

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2018
• Primary Completion (Actual): February 29, 2024
• Study Completion (Estimated): May 29, 2027

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Central Nervous System Depressants; Protective Agents; Neuroprotective Agents; Anti-Infective Agents, Local; prednisolone acetate
• Other Study ID Numbers: 2017-A03259-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No