Health TrialsbyHealthPanel

Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

ConditionLumbar Discogenic Pain (Disorder)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGelscom SAS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ethanol gel

    Device

    Intradiscal injection of ethanol gel

  • Prednisolone acetate

    Drug

    Intradiscal infiltration of steroids

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: Ethanol gelExperimental treatment 1 intervention
Group B: Steroid infiltrationActive comparator 1 intervention

Trial outcomes

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)

Time frame
Month 3

Secondary outcomes

1

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

Time frame
Month 12
2

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

Time frame
Month 24
3

Short-term safety profile

Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions

Time frame
Month 3
4

Long-term safety profile

Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions

Time frame
Month 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gelscom SAS

Lead sponsor

CEISO

Collaborator

Source ClinicalTrials.gov
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