Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-29

Study Completion Date

2027-05-29

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.

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Detailed Description

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Conditions

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Lumbar Discogenic Pain (Disorder)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Ethanol gel

Intervention Type DEVICE

Intradiscal injection of ethanol gel

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

Group Type ACTIVE_COMPARATOR

Prednisolone acetate

Intervention Type DRUG

Intradiscal infiltration of steroids

Interventions

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Ethanol gel

Intradiscal injection of ethanol gel

Intervention Type DEVICE

Prednisolone acetate

Intradiscal infiltration of steroids

Intervention Type DRUG

Other Intervention Names

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DISCOGEL® HYDROCORTANCYL 2,5 POUR CENT

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No