Short-term effectiveness of Gabapentin versus Placebo in acute Lumbosacral Radiculalgia by herniation disc: a prospective, multicentric, randomized, controlled, double-blind study (GRADE)
This study is investigating how well a medicine called gabapentin works for people experiencing nerve pain in their lower back. This kind of pain, known as lumbosacral radiculalgia, often happens when a slipped disc presses on nerves. Participants will either receive gabapentin or a dummy pill (placebo). Doctors will measure changes in pain levels shortly after starting treatment (between day 1 and day 4) using a special pain scale. They are trying to find out if gabapentin is more effective than the placebo in easing this specific type of back pain. The study is double-blind, meaning neither the patients nor their doctors will know who is getting the real medicine.
At a glance
What is this study about?
This study is looking into a common type of back and leg pain. Sometimes, a problem with one of the discs in your spine, often called a 'slipped disc', can press on the nerves in your lower back. This can cause pain, numbness, or tingling that travels down your leg. This is known as lumbosacral radiculalgia.
The study aims to find out if a medicine called gabapentin can help reduce this nerve pain in the short term. Gabapentin is already used for various types of nerve pain, but this study specifically checks its effectiveness for pain caused by a slipped disc. Half of the participants will receive gabapentin, and the other half will receive a 'dummy' pill, called a placebo. A placebo looks exactly like the real medicine but contains no active drug. Comparing against a placebo helps researchers truly understand if the medicine itself is causing any effects.
Researchers will closely monitor participants' pain levels, mainly using a simple pain scale, from the first day they take the treatment up to four days later. They will also look at how many people feel a significant improvement and track any side effects. This research is important because it could help doctors understand better ways to manage this often-debilitating nerve pain.
Key takeaways
- The study tests gabapentin for lower back nerve pain from a slipped disc.
- It compares gabapentin to a dummy pill (placebo).
- Pain levels will be checked very frequently over a few days.
- All adults (18+) with this specific nerve pain can be considered.
- It's a short-term study to see initial effects.
- You won't know if you get gabapentin or the placebo.
Who may be eligible?
To join this study, people must be aged 18 or older. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women, as the condition affects everyone equally.
Participants will need to have confirmed lumbosacral radiculalgia, which is nerve pain originating from the lower back, typically due to a slipped disc. The medical team will check your health to make sure that taking part in the study is right for you and that you meet all other specific health requirements for safety reasons.
- Are you 18 years old or older?
- Do you have nerve pain in your lower back (lumbosacral radiculalgia)?
- Has your nerve pain been caused by a slipped disc?
- Are you able to attend follow-up appointments for a few days?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would first have a check-up to make sure you are suitable. If you are, you would be given either gabapentin or a dummy pill (placebo) to take for a short period. The study is designed to be short-term, focusing on changes in your pain over just a few days, specifically between Day 1 and Day 4, with some follow-up up to Day 7. During this time, you would be asked to regularly report your pain levels, likely using a pain scale. The doctors would also monitor you for any side effects and check how your lower back pain and other symptoms change. Details about the exact number of visits, how long each visit might be, and any specific tests will be explained fully by the study team.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is lumbosacral radiculalgia?
It's a type of nerve pain that starts in your lower back and often travels down your leg, usually caused by a slipped disc pressing on a nerve.
What is gabapentin?
Gabapentin is a medicine often used to treat different types of nerve pain.
What is a 'placebo'?
A placebo is a 'dummy' pill that looks just like the real medicine but contains no active drug. It helps researchers see if the real medicine actually works.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your doctor will know during the study. This is called 'double-blind' research and stops people's expectations from affecting the results.
How long will I be in the study?
The main part of the study focuses on your pain change between Day 1 and Day 4, with some follow-up up to Day 7.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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