Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

Gelscom SAS230 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

230

Conditions

Lumbar Discogenic Pain (Disorder)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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

Short-term safety profile

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

Time frame: Month 3

Long-term safety profile

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

Time frame: Month 12

Long-term safety profile

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

Time frame: Month 24

Questionnaire OSWESTRY

Describe the rate of subjects improved 24 months after treatment: OSWESTRY scale

Time frame: Month 24

Questionnaire MacNab

Subjective improvement 24 months after treatment: MacNab scale

Time frame: Month 24

Radiography

Describe radiologic evolution of the lesions: radiography of the herniated disc

Time frame: Month 3

Radiography

Describe radiologic evolution of the lesions: radiography of the herniated disc

Time frame: Month 12

Radiography

Describe radiologic evolution of the lesions: radiography of the herniated disc

Time frame: Month 24

Magnetic Resonance Imaging

Describe radiologic evolution of the lesions: MRI of the herniated disc

Time frame: Month 3

Procedures costs

Compare the cost linked to the DISCOGEL® procedure and the cost linked to a steroid infiltration or surgery

Time frame: Day 0

Procedures durations

Compare the duration of the treatment procedures between a DISCOGEL® injection and a steroid infiltration or surgery

Time frame: Day 0

Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

Overview

Conditions

Interventions

Eligibility

Locations (5)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts