All studies
Active not recruitingPHASE4INTERVENTIONAL

Pentoxifylline and Lumbar Radiculopathy

This study is trying to find out if a medicine called pentoxifylline can help people who suffer from sciatica, which is pain caused by a 'slipped disc' in their lower back. Sciatica usually causes pain, numbness, or tingling that travels down the leg. Participants will try two different treatment plans at different times: one will include pentoxifylline along with regular pain relief like ibuprofen and paracetamol, and the other will be just the regular pain relief. Researchers want to see if pentoxifylline adds any benefit in reducing pain and improving how people feel, and if it's safe to use. This kind of study helps doctors understand better ways to treat this common condition.

At a glance

Status
Active not recruiting
Phase
PHASE4
Sponsor
St Joseph University, Beirut, Lebanon
Enrolment target
67
Start
01 Jun 2018
Estimated completion
01 Dec 2026

What is this study about?

If you've ever had pain in your lower back that shoots down your leg, you might have experienced something called 'lumbar radiculopathy,' often known as sciatica. It usually happens when a disc in your spine, which acts like a cushion between your backbones, bulges or 'slips.' This can press on nerves, causing pain, numbness, or tingling in your leg.

This particular study is looking into a medicine called pentoxifylline. While pentoxifylline isn't usually prescribed for back pain, researchers want to see if it could be a helpful new option for people with sciatica caused by a slipped disc. They are comparing it to typical pain relief medicines like ibuprofen to understand if it makes a difference.

The main goal is to find out how well pentoxifylline works to ease the pain and improve overall comfort for individuals with this condition, and also to make sure it's safe. Findings from studies like this help doctors to offer the best possible treatments for back and leg pain in the future.

Key takeaways

  • This study explores a new treatment for back pain that goes down your leg (sciatica).
  • It compares pentoxifylline with standard pain relief for people with a slipped disc.
  • Participation involves taking different medicines for two 15-day periods.
  • You'll have medical check-ups and rate your pain.
  • This research aims to find better ways to treat sciatica.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be between 18 and 70 years old and have pain in one leg (sciatica) that doctors confirm is due to a slipped disc in your lower back. This would be shown on a scan like an MRI, and doctors would agree that the scan matches your symptoms.

There are certain reasons why you wouldn't be able to join. For example, if your back pain is so severe you need surgery right away, or if you have a serious condition called cauda equina syndrome. Also, if your scan doesn't clearly show a slipped disc matching your pain, you wouldn't be suitable. If you have health problems like high blood pressure, kidney issues, or stomach ulcers that mean you can't take anti-inflammatory medicines, or if you're pregnant, you can't take part. They also can't include you if you've had a bad reaction to pentoxifylline, pregabalin, or paracetamol before.

Additionally, if you have liver problems, a history of drug abuse, or are currently taking certain strong pain medicines like tramadol or morphine, or antidepressants, you wouldn't be eligible. It's also important that you can attend all follow-up appointments.

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.

  1. I am between 18 and 70 years old.
  2. I have pain in one leg (sciatica) caused by a slipped disc, confirmed by a scan.
  3. I don't need immediate surgery for my back pain.
  4. I haven't had a bad reaction to pentoxifylline, ibuprofen, paracetamol, or pregabalin before.
  5. I am not pregnant and don't have severe health issues like liver or kidney problems.
  6. I am able to attend all planned follow-up appointments.
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be asked to take different treatments over two separate periods, each lasting 15 days. One period will involve taking pentoxifylline tablets once a day, along with prescribed pain relief like ibuprofen (twice a day), paracetamol (three times a day), and pregabalin (twice a day). During the other 15-day period, you'll take the same pain relief medicines (ibuprofen, paracetamol, pregabalin) but without the pentoxifylline. The order in which you take these two treatment plans will be decided randomly, like flipping a coin.

Before starting, doctors will record your basic health information and look at your MRI scans of your lower back. Throughout the study, you'll have check-ups including a physical examination to test the strength in your legs. You'll also be asked to rate your pain on a simple scale and describe how much better you feel overall. The total duration of your active participation, including both treatment periods, will be about 30 days.

Potential risks and benefits

Taking part in this study might offer a potential benefit by helping to find out if pentoxifylline can improve your back and leg pain. You'll also receive close medical attention and standard pain relief as part of the study. However, there are potential risks, as with any medicine, side effects could occur from pentoxifylline, ibuprofen, paracetamol, or pregabalin. Your doctor will discuss specific potential side effects if you are considering joining. Remember, joining a study is always your choice, and you have the right to withdraw at any time without giving a reason, which will not affect your future medical care.

Locations (1)

  • Hotel Dieu de France Hospital
    Verified postcode
    Beirut, Lebanon

Common questions

What is sciatica?

Sciatica is leg pain, numbness, or tingling caused by a pinched nerve in your lower back, often from a 'slipped disc'.

What is pentoxifylline?

Pentoxifylline is a medicine being tested to see if it can help reduce the pain from sciatica caused by a slipped disc.

Will I always know what medicine I'm taking?

Yes, this study is a 'crossover' design, meaning you will know what medicines you are taking during each treatment period, as pentoxifylline is added in one phase.

How long will the study last for me?

Your participation will involve two periods of treatment, each lasting 15 days, so about a month of active treatment and assessments.

Can I leave the study at any time?

Yes, you are completely free to leave the study at any point without needing to give a reason, and it won't affect your medical care.

How to find out more

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

Discussion

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