RecruitingPHASE3INTERVENTIONAL

Efficacy of an Intraoperative Periradicular Application of Platelet Rich Fibrin (PRF) on the Intensity of Residual Post-surgical Neuropathic Pain After a Surgery for Disc Herniation

After back surgery for a slipped disc, some people experience ongoing nerve pain, which can be tricky to treat. Doctors are testing a new approach using something called Platelet Rich Fibrin (PRF). This special healing material is made from a patient's own blood and is known for its anti-inflammatory (reducing swelling) and pain-relieving properties. In this study, some patients will receive PRF around the nerves during their surgery, while others will have surgery as usual. The aim is to see if adding PRF helps to significantly reduce residual nerve pain after the operation, offering a potentially better way to manage this common problem and improve recovery.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University Hospital, Strasbourg, France

Enrolment target

Start

23 Feb 2022

Estimated completion

01 Jan 2028

Neuropathic Pain Chronic Postsurgical Pain

What is this study about?

When someone has a slipped disc in their lower back, it can press on nerves and cause pain. Sometimes, even after surgery to fix the disc, a person can still have ongoing nerve pain, which doctors call neuropathic pain. This can be persistent and difficult to manage with standard treatments like certain antidepressants or medications for nerve pain.

This study is exploring a new technique to try and prevent or reduce this lasting pain. It focuses on using something called Platelet Rich Fibrin, or PRF for short. PRF is created using a small sample of a patient's own blood. It's rich in healing factors and is thought to help reduce inflammation and pain, and support tissue repair. Because it comes from your own body, it's generally well-tolerated.

The idea is that if PRF is applied around the affected nerves during the disc surgery, it might help those nerves heal better and reduce the chances of developing chronic pain afterwards. The study is comparing patients who receive this PRF treatment during surgery with those who have the standard surgery alone, to see if PRF makes a real difference in how much pain people experience after their operation.

Key takeaways

This study is testing a new way to reduce nerve pain after back surgery.
It uses Platelet Rich Fibrin (PRF) made from your own blood, known for healing properties.
Some patients get PRF during surgery, others just standard surgery.
The goal is to find better ways to manage chronic post-surgery pain.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To be considered for this study, you need to be an adult (18 years or older) who has been diagnosed with a slipped disc in your lower back that requires surgery. You also need to be able to understand what the study involves, including any potential risks, and be willing to give your written permission to take part. It's also important that you have health insurance through a social security scheme.

There are certain reasons why you might not be able to join. For example, if you've had back surgery before for a slipped disc, or if you have certain medical conditions like HIV, active cancer, or some liver illnesses. If you're pregnant or breastfeeding, or if you're taking long-term steroid medication, you also wouldn't be able to participate. The study also cannot include individuals who are part of another clinical trial at the same time.

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?
Do you have a slipped disc needing surgery?
Do you understand what the study involves?
Have you *not* had back surgery before (for a slipped disc)?
Are you *not* pregnant or breastfeeding?
Do you *not* have certain serious health conditions (like active cancer or HIV)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of two groups, like flipping a coin. You'll either have your standard disc surgery with the addition of PRF applied around the nerve during the operation, or you'll have the standard disc surgery on its own. You won't know which group you're in, and neither will the person assessing your pain after the surgery.

After your surgery, the research team will closely monitor your recovery and how you're feeling. This will involve regular check-ups and assessments to understand your pain levels and overall well-being. The total duration of your participation in the study, including all follow-up appointments, would be explained to you in detail before you agree to join.

Potential risks and benefits

There's a potential benefit that the PRF treatment could help reduce your post-surgery pain more effectively than surgery alone, potentially improving your recovery and quality of life. As with any medical procedure, there are potential risks, which will be fully explained to you by the medical team. These might include risks associated with blood drawing for PRF, or potential side effects from the surgical procedure itself. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Les Hôpitaux Universitaires
Verified postcode
Strasbourg, France· Recruiting

Common questions

What is PRF and where does it come from?

PRF stands for Platelet Rich Fibrin. It's a natural healing substance made from a small sample of your own blood, collected just like a regular blood test.

Will I know if I receive the PRF treatment during surgery?

No, you won't know if you've received the PRF treatment or just the standard surgery. This is to make sure the study results are as fair and unbiased as possible.

What kind of pain is this study trying to help?

This study is focusing on 'neuropathic pain,' which is a type of long-lasting nerve pain that can sometimes remain after surgery for a slipped disc.

Will my regular medical care be affected if I join?

No, joining or not joining the study will not affect the usual medical care you receive for your condition.

How long will I be involved in the study?

The total length of your participation, including follow-up appointments, will be explained fully by the study team, but it will involve monitoring your pain and recovery after surgery.

How to find out more

Erci SALVAT

eric.salvat@chru-strasbourg.fr +33 3 88 12 85 02 Official trial record

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