Lumbar Discogenic Pain (Disorder)IDISNCT03415828
Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain
A study testing Ethanol gel and Prednisolone acetate in people with Lumbar Discogenic Pain (Disorder), run by Gelscom SAS at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Discogenic Pain (Disorder)
- What is being tested?
- Ethanol gel and Prednisolone acetate
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 5 sitesFrance
- Study dates
- 29 May 2018to 29 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Camélia Bentaleb contact
5 sites in 1 country
France5 sites, 3 recruiting
- Recruiting
Hospital Pellegrin
Bordeaux
Mathieu de Sèze, Pr.
- Terminated
Hospital St-Dié-des-Vosges
Saint-Dié
- Recruiting
Hospital SUD La Reunion
Saint-Pierre
Romain Kohlmann, Dr.
- Recruiting
Hospital St-Etienne
Saint-Priest-en-Jarez
Sylvain Grange, Dr.
- Terminated
Hospital Valence
Valence
About this study
Official title: 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.
Read more
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)
- Being tested
- Ethanol gel, Prednisolone acetate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanol gelDevice
Also called DISCOGEL®
Intradiscal injection of ethanol gel
Prednisolone acetateDrug
Also called HYDROCORTANCYL 2,5 POUR CENT
Intradiscal infiltration of steroids
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Prednisolone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Month 3
Secondary outcomes (13)
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
Measured: 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
Measured: Month 24
Short-term safety profile
Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions
Measured: Month 3
Long-term safety profile
Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions
Measured: Month 12
Long-term safety profile
Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions
Measured: Month 24
Questionnaire OSWESTRY
Describe the rate of subjects improved 24 months after treatment: OSWESTRY scale
Measured: Month 24
Questionnaire MacNab
Subjective improvement 24 months after treatment: MacNab scale
Measured: Month 24
Radiography
Describe radiologic evolution of the lesions: radiography of the herniated disc
Measured: Month 3
Radiography
Describe radiologic evolution of the lesions: radiography of the herniated disc
Measured: Month 12
Radiography
Describe radiologic evolution of the lesions: radiography of the herniated disc
Measured: Month 24
Magnetic Resonance Imaging
Describe radiologic evolution of the lesions: MRI of the herniated disc
Measured: Month 3
Procedures costs
Compare the cost linked to the DISCOGEL® procedure and the cost linked to a steroid infiltration or surgery
Measured: Day 0
Procedures durations
Compare the duration of the treatment procedures between a DISCOGEL® injection and a steroid infiltration or surgery
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start29 May 2018
- Primary completion29 Feb 2024
- Study completion29 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Discogenic Pain (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gelscom SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEISO
- Responsible party
- Sponsor
- Investigators
- Mathieu de Sèze, Dr, Study chair, CHU Bordeaux Pellegrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415828
- Sponsor's protocol ID
- 2017-A03259-44
- Acronym
- IDIS
- Status last verified
- Sep 2025
- First submitted
- 9 Jan 2018
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradiscal Gelified Ethanol Versus Intradiscal Steroid in Refractory Lumbar Discogenic Pain: a Randomized Single-blind Study
- ClinicalTrials.gov ID
- NCT03415828
- Acronym / sponsor ID
- IDIS / 2017-A03259-44
- Conditions
- Lumbar Discogenic Pain (Disorder)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Gelscom SASIndustry (pharma, biotech, devices)
- Collaborators
- CEISO
- Study start
- 29 May 2018 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 May 2027 (estimated)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ethanol gel | Experimental | Device: Ethanol gelCE-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 | Active comparator | Drug: Prednisolone acetateAuthorized 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethanol gelAlso: DISCOGEL®Intradiscal injection of ethanol gel | Device | Ethanol gel |
| Prednisolone acetateAlso: HYDROCORTANCYL 2,5 POUR CENTIntradiscal infiltration of steroids | Drug | Steroid infiltration |
Primary outcome
Short-term efficacy profile
Time frame: 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)
13 secondary outcomes
Long-term efficacy profile
Time frame: Month 12
Long-term efficacy profile
Time frame: Month 24
Short-term safety profile
Time frame: Month 3
Long-term safety profile
Time frame: Month 12
Long-term safety profile
Time frame: Month 24
Questionnaire OSWESTRY
Time frame: Month 24
Questionnaire MacNab
Time frame: Month 24
Radiography
Time frame: Month 3
Radiography
Time frame: Month 12
Radiography
Time frame: Month 24
Magnetic Resonance Imaging
Time frame: Month 3
Procedures costs
Time frame: Day 0
Procedures durations
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Camélia Bentaleb contact
Mathieu de Sèze, Dr study chair
CHU Bordeaux Pellegrin
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanol gel and Prednisolone acetate in people with Lumbar Discogenic Pain (Disorder), run by Gelscom SAS at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathieu De Sèze, Dr (+335 56 79 55 16, corinne.pallas@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term efficacy profile (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.