Active not recruitingNAINTERVENTIONAL

Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients With Chronic Low Back Pain

This research is investigating a treatment called radial shockwave therapy for people with chronic lower back pain. This therapy uses sound waves and has been used for other painful conditions for many years. We want to see how effective it is for back pain when combined with other pain treatments, like physiotherapy. The study will compare different ways of giving the shockwave therapy. We're also looking at whether the treatment works differently for people who have previously had surgery on their lower back compared to those who haven't. The aim is to find the best way to help people manage their long-term back pain.

At a glance

Status

Active not recruiting

Phase

Sponsor

Ruhr University of Bochum

Enrolment target

400

Start

18 Sep 2022

Estimated completion

07 Dec 2025

Chronic Low-back Pain (cLBP)

What is this study about?

Many people live with long-lasting pain in their lower back. This kind of pain can really affect daily life. Doctors and researchers are always looking for better ways to help manage it. This study is focusing on a treatment called radial shockwave therapy. You might have heard of shockwave therapy being used for other conditions, like heel pain or tennis elbow. It uses special sound waves directed at the painful area. We want to see how well it works for lower back pain.

This research is part of a broader approach to pain treatment. This means that people in the study will also receive other pain management methods, such as physiotherapy and injections, as needed. We are trying out a few different ways of giving the shockwave therapy to see which one works best. We also want to understand if people who have had back surgery before respond differently to the treatment compared to those who haven't.

By carefully comparing these different approaches, we hope to learn more about how to use radial shockwave therapy most effectively for chronic lower back pain. This could lead to better treatment options in the future, helping more people find relief from their pain.

Key takeaways

Exploring a new approach for long-lasting lower back pain.
Compares different ways to give radial shockwave therapy.
Includes people who have and haven't had back surgery.
Therapy provided as part of wider hospital-based pain care.
Aims to improve future back pain treatments.

Who may be eligible?

To be part of this study, you need to be an adult between 18 and 80 years old, and you must have had ongoing lower back pain for at least three months.

However, there are some reasons why you couldn't join. For example, if your leg pain (sciatica) is worse than your back pain, or if you've recently had a new back injury or infection. People who are pregnant cannot participate, nor can those taking certain blood-thinning medications or who have a bleeding disorder.

Also, if you've had an injection in your lower back in the last six weeks, or if you have a condition called fibromyalgia, you wouldn't be able to join this particular study. The doctors running the study will check carefully to make sure it's safe and appropriate for you to take part.

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 between 18 and 80 years old?
Have you had lower back pain for at least 3 months?
Is your back pain (not leg pain) your main problem?
Are you not currently pregnant?
Have you avoided back injections in the last 6 weeks?
Do you not have a diagnosed bleeding disorder or take blood thinners?

Answer every question to see your result.

What does participation involve?

If you join this study, you will stay in the hospital while receiving treatment. You'll receive radial shockwave therapy following a specific plan, along with other usual pain treatments like physical therapy and injections. Doctors will also check how your pain is progressing and how you’re feeling. The study will compare different versions of the shockwave therapy protocols.

Potential risks and benefits

Taking part in a study like this could potentially offer new ways to manage your chronic lower back pain. While radial shockwave therapy is generally considered safe, like any medical treatment, there's always a chance of side effects, though usually mild and temporary, such as redness or discomfort in the treated area. You will be fully informed of any potential risks before you agree to participate, and importantly, you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Klinik Blankenstein
Verified postcode
Hattingen, Germany

Common questions

What is radial shockwave therapy?

It's a treatment that uses special sound waves delivered through a device placed on your skin to help with pain in the treated area.

Why is this study only for people staying in hospital?

This study is designed to carefully compare different ways of giving the treatment and to combine it with other pain therapies, which is easier to do when patients are staying in a hospital setting.

What does 'multimodal pain therapy' mean?

It means receiving a combination of different treatments for your pain, which might include things like exercises, injections, and the shockwave therapy, all working together.

Will my regular back treatment stop if I join the study?

No, the shockwave therapy will be part of your overall pain treatment plan, which may continue to include other therapies like physiotherapy.

What's the difference between people who had surgery and those who didn't?

The study wants to see if the shockwave therapy works differently for people who have previously had an operation on their lower back compared to those who haven't.