RecruitingNAINTERVENTIONAL

Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

This study is looking at two ways to treat ongoing lower back pain that hasn't gotten better with usual care. One treatment is an injection of a special gel called DISCOGEL®, which has been used since 2007. The other is a common steroid injection. Researchers want to compare how well these treatments work and how safe they are over two years, especially after DISCOGEL® recently got its European safety approval reconfirmed. It's a large study involving many hospitals, and neither the patients nor the doctors evaluating them will know which treatment is given. They'll also look at the costs involved. This helps ensure fair results and provides important information about how these treatments perform in real-world use.

At a glance

Status

Recruiting

Phase

Sponsor

Gelscom SAS

Enrolment target

230

Start

29 May 2018

Estimated completion

29 May 2027

Lumbar Discogenic Pain (Disorder)

What is this study about?

If you've been living with ongoing lower back pain that comes from your spinal discs and hasn't improved with typical treatments, you might be interested in a clinical study happening now. This study, called "Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain," is comparing two different injection treatments: a special gel called DISCOGEL® and a more common steroid injection.

DISCOGEL® has been around for some time, and tens of thousands of kits have been used. It recently had its safety and quality mark (CE mark) reconfirmed in Europe. This study is part of what's called a "Post-Market Clinical Follow-up" – basically, it's a careful check to see how well DISCOGEL® works and how safe it is over a longer period, specifically two years, when used by a lot of patients in real-world situations. They will be comparing it directly with a standard steroid injection, which is also a well-understood treatment.

The main goal is to find out which of these treatments is better at relieving pain in the short term. The study is designed very carefully: it's taking place in many hospitals across the country, and neither you nor the doctors assessing your progress will know which injection you've received. This helps make sure the results are fair and accurate, giving us a clear picture of how these treatments compare.

Key takeaways

Compares DISCOGEL® and steroid injections for ongoing lower back pain.
Aims to find out which treatment is safer and more effective over two years.
Patients and doctors won't know which injection is given (it's 'blinded').
Participation involves a single injection and regular check-ups for two years.
Could help you and future patients with similar back pain.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have had lower back pain caused by your spinal discs for at least two months. This pain should not have improved with standard treatments, and you shouldn't have had surgery on the affected disc(s) before. Importantly, the type of pain you have must show up on an MRI scan.

There are also some reasons why you might not be able to join. For example, if you've recently had surgery on the disc, have only nerve pain that shoots down your leg (without back pain), or have been on long-term sick leave for more than a year due to your symptoms. They also can't include you if you have certain medical conditions like infections, severe blood clotting problems, or other serious inflammatory diseases. Women who are pregnant or planning to get pregnant during the study period cannot participate.

Finally, you need to be able to read and understand the study information and give your consent. You also shouldn't be involved in another clinical trial or testing another experimental drug within 30 days of joining this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had lower back pain from your discs for at least two months that hasn't improved with regular treatments?
Do your MRI scans show disc problems that match your pain?
Have you never had surgery on the specific disc(s) causing your pain?
Are you able to agree to take part and understand the study information?
Are you not pregnant or planning to become so during the study?

Answer every question to see your result.

What does participation involve?

If you agree to take part, you'll be assigned either the DISCOGEL® injection or a steroid injection, but neither you nor your doctors will know which one you're getting. You'll have regular follow-up appointments and assessments over a two-year period to check your pain levels, how you're feeling, and any side effects. This might involve filling out questionnaires and having physical examinations. The total duration of your participation will be two years, including the initial treatment and the follow-up period. Both DISCOGEL® and the steroid injection are approved for use.

Potential risks and benefits

Participating in this study could potentially offer you relief from your persistent back pain if either treatment proves effective. You'll also be contributing to important medical research that could help many others with similar conditions in the future. However, as with any medical procedure, there are potential risks associated with injections, such as pain, bleeding, infection, or other complications, although these are generally uncommon. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Hospital Pellegrin
Verified postcode
Bordeaux, France· Recruiting
Hospital St-Dié-des-Vosges
Verified postcode
Saint-Dié, France· Terminated
Hospital SUD La Reunion
Verified postcode
Saint-Pierre, France· Recruiting
Hospital St-Etienne
Verified postcode
Saint-Priest-en-Jarez, France· Recruiting
Hospital Valence
Verified postcode
Valence, France· Terminated

Common questions

What is 'lumbar discogenic pain'?

It's a type of lower back pain that comes directly from one or more of the spongy discs between the bones in your lower spine.

What is DISCOGEL®?

It's a special gel injection designed to treat certain types of back pain caused by discs. It's an approved medical device in Europe.

What does 'refractory' pain mean?

It means the pain hasn't gotten better, or hasn't responded well, to standard treatments like pain relief medicines or physiotherapy.

Will I know which treatment I'm getting?

No, it's a 'blinded' study, meaning neither you nor the doctors assessing you will know if you're getting DISCOGEL® or the steroid injection. This helps ensure fair results.

How long will I be involved in the study?

If you join, you'll be followed up for two years to see how the treatment affects you over time.

How to find out more

Mathieu De Sèze, Dr

corinne.pallas@chu-bordeaux.fr +335 56 79 55 16 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.