Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Randomized, double-blind, parallel-groups, active - and placebo-controlled study to Evaluate the efficacy of a fixed combination of diclofenac 75 mg + thiocolchicoside 4 mg as solution for injection, in reLIEving back pain symptoms. Controlled study vs. dicloFenac 75 mg solution for injection and placebo. RELIEF Study

The RELIEF study is a research project designed to explore a new way to treat lower back pain. It focuses on an injected medicine that contains a mix of two drugs: diclofenac and thiocolchicoside. This new combination is being compared against an injection of diclofenac by itself, and also against a placebo – which is an injection that looks like the real medicine but contains no active drug. This helps researchers understand if the new combination is truly effective. The main goal is to see how much pain relief patients get over the first three days and to check for improvements in their ability to move. Researchers are also carefully monitoring for any side effects. This is a Phase 3 study, which means it's one of the final steps before a new treatment might become widely available.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Epifarma S.r.l.

Enrolment target

216

Start

22 Nov 2024

Low back pain (LBP). LBP is one of the most frequent and disabling health problems. It is estimated that about 80% of adults will experience an episode of acute or chronic LBP at least once during their lifetime The mechanism underlying acute LBP may be disk-muscle- or posterior articulation related. The aim of the treatment is always to obtain early and maximum relief of the local and regional pain as well as to improve mobility and physical function.

What is this study about?

Imagine you're suffering from lower back pain, which can be incredibly debilitating and stop you from doing everyday things. In fact, most adults experience this at some point in their lives. When your back hurts, whether it's from a disc, muscle strain, or a joint issue, the main aim is always to quickly reduce the pain and help you move more freely again.

This study, called RELIEF, is looking at a new injection designed to tackle lower back pain. It combines two different medicines: diclofenac, which is a common painkiller and anti-inflammatory, and thiocolchicoside, which is a muscle relaxant. The researchers want to find out if this combination works better at easing pain and helping you move than diclofenac alone, or a dummy injection (called a placebo).

To figure this out, people taking part will be split into three groups: one group gets the new combination medicine, another gets diclofenac on its own, and the third gets the placebo. Neither the patients nor the doctors will know who is getting which treatment. This helps ensure the results are as fair and unbiased as possible. The main thing they'll be checking is how much your pain goes down over the first few days, and they'll also look at how much your movement improves and if you need other pain relief. They'll also be keeping a very close eye on your safety throughout the study.

Key takeaways

The study aims to find a better treatment for lower back pain.
It tests a new combination injection against existing treatment and a placebo.
Patients and doctors won't know which treatment is given.
Pain levels and movement will be closely monitored for 7 days.
Safety and side effects are a major focus of the research.

Who may be eligible?

This study is looking for adult volunteers, aged 18 or older, who are dealing with lower back pain. Both men and women can take part.

However, not everyone with lower back pain will be able to join. There will be specific health requirements that researchers need to check to make sure the study is safe for you and that the results are clear. For example, people with certain medical conditions or those taking particular medications might not be eligible.

If you're interested in potentially joining, the best step is to talk to your doctor. They can help you understand if your specific health situation matches the study's requirements and whether it might be a suitable option for you.

Quick self-check

Are you 18 years old or older?
Are you currently experiencing lower back pain?
Are you able to attend study visits regularly for about 7 days?
Are you comfortable with receiving injections?
Are you willing to keep track of your pain and activities?

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 full health check by the study doctors to make sure you're a good fit. Once accepted, you would receive injections of one of the study medicines. These injections would be given into a muscle. Throughout the study, typically over 7 days, you would be asked to regularly report how much pain you're feeling, probably using a scale, and your ability to move. You'd likely have a few follow-up visits where nurses or doctors would measure your muscle stiffness and ask about your daily activities and any pain you experience. They will also track if you need to take any other pain relief medication. There will be checks of your blood pressure, heart rate, and possibly blood tests and an ECG (heart trace) to monitor your overall health. The total time you would be actively involved in the study assessments would be about 7 days.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new treatment that could reduce your lower back pain effectively, or from the close medical monitoring you'll receive. However, there's also a chance the treatment might not work for you, or you might receive the placebo. Potential risks include side effects from the medications, such as pain or discomfort at the injection site, or other reactions. The study team will explain all known potential side effects. It's very important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

—
Italy
—
Greece

Common questions

What kind of back pain is this study for?

This study is for people experiencing lower back pain, which can come from muscles, discs, or joints in the lower back.

What is a 'placebo' injection?

A placebo is a 'dummy' injection that looks exactly like the real medicine but contains no active drug. It helps researchers see if the actual medicine truly works better than nothing.

Will I know which medicine I'm getting?

No, neither you nor your doctor will know whether you are receiving the new combination, diclofenac alone, or the placebo. This helps ensure fair results.

How long does the study last?

The main part of the study involves assessments and tracking your pain for the first 7 days after starting treatment.

What if I get worse during the study?

Your safety is a top priority. You will be closely monitored, and if your pain worsens or you have any concerns, you can use rescue medication or withdraw from the study at any time.