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Recruiting NCT03415828

Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

No phase Interventional Lumbar Discogenic Pain (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ethanol gel, Prednisolone acetate.
Who it may be relevant to
Registry conditions: Lumbar Discogenic Pain (Disorder). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Ethanol gel
    Intradiscal injection of ethanol gel
  • Drug Prednisolone acetate
    Intradiscal infiltration of steroids

Primary outcome measures

  • Short-term efficacy profile [Time frame: Month 3]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

France · 5 centers
  • Hospital Pellegrin — Bordeaux
  • Hospital St-Dié-des-Vosges — Saint-Dié
  • Hospital SUD La Reunion — Saint-Pierre
  • Hospital St-Etienne — Saint-Priest-en-Jarez
  • Hospital Valence — Valence

Identifiers

NCT: NCT03415828 · 2017-A03259-44

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗