Lumbar Discogenic Pain (Disorder) Clinical Trial
— IDISOfficial title:
Intradiscal Gelified Ethanol Versus Intradiscal Steroid in Refractory Lumbar Discogenic Pain: a Randomized Single-blind Study
| Verified date | November 2023 |
| Source | Gelscom SAS |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 83 |
| Est. completion date | November 29, 2025 |
| Est. primary completion date | February 29, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Hospital Pellegrin | Bordeaux | |
| France | Hospital SUD La Reunion | Saint-Pierre | |
| France | Hospital St-Etienne | Saint-Priest-en-Jarez | |
| France | Hospital St-Dié-des-Vosges | St-Dié-des-Vosges | |
| France | Hospital Valence | Valence |
| Lead Sponsor | Collaborator |
|---|---|
| Gelscom SAS | CEISO |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | Month 3 | |
| Secondary | 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 | Month 12 | |
| Secondary | 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 | Month 24 | |
| Secondary | Short-term safety profile | Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions | Month 3 | |
| Secondary | Long-term safety profile | Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions | Month 12 | |
| Secondary | Long-term safety profile | Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions | Month 24 | |
| Secondary | Questionnaire OSWESTRY | Describe the rate of subjects improved 24 months after treatment: OSWESTRY scale | Month 24 | |
| Secondary | Questionnaire MacNab | Subjective improvement 24 months after treatment: MacNab scale | Month 24 | |
| Secondary | Radiography | Describe radiologic evolution of the lesions: radiography of the herniated disc | Month 3 | |
| Secondary | Radiography | Describe radiologic evolution of the lesions: radiography of the herniated disc | Month 12 | |
| Secondary | Radiography | Describe radiologic evolution of the lesions: radiography of the herniated disc | Month 24 | |
| Secondary | Magnetic Resonance Imaging | Describe radiologic evolution of the lesions: MRI of the herniated disc | Month 3 | |
| Secondary | Procedures costs | Compare the cost linked to the DISCOGEL® procedure and the cost linked to a steroid infiltration or surgery | Day 0 | |
| Secondary | Procedures durations | Compare the duration of the treatment procedures between a DISCOGEL® injection and a steroid infiltration or surgery | Day 0 |