Active not recruitingOBSERVATIONAL

Personalisation of Prosthetic Care for Lower- Limb Amputees

This study is investigating why some people who have had a lower-leg amputation develop lower back pain. Many people who lose a leg, often due to diabetes or blood vessel problems, experience difficulties walking and daily life. Back pain is very common among this group, and can make things even harder. Researchers believe that things like how someone walks with their prosthetic leg, how well the prosthetic fits, and even feelings like stress or depression, can all play a part. The goal is to understand these different factors better. By doing so, the study hopes to find out what causes back pain and how it develops over the first year after amputation. This information will help doctors and therapists create more effective and personalised care programmes for people with a lower-leg amputation.

At a glance

Status

Active not recruiting

Sponsor

University of Bath

Enrolment target

Start

01 Sep 2023

Estimated completion

01 Oct 2026

Low Back Pain

What is this study about?

When someone has a lower-leg amputation, it can completely change how they move and live their everyday life. While a prosthetic leg helps a lot, many people still face challenges. One of the biggest problems for people with a lower-leg amputation is lower back pain. This study wants to understand why this back pain happens and how different things might contribute to it. Things like how you walk with your prosthetic leg, how your muscles work, and even your feelings and thoughts, could all play a role.

At the moment, we don't fully understand why some people with a lower-leg amputation develop back pain and others don't, or exactly when it tends to start. This study will carefully look at people over 12 months after their amputation. Researchers will examine how they walk, how their back and leg muscles are used, and how these factors might be linked to different types of pain. By gathering all this information, the study aims to identify the key reasons for back pain.

The main purpose of this research is to learn more about the link between having a lower-leg amputation and getting back pain. This knowledge is really important because it will help healthcare professionals develop better and more effective rehabilitation programmes and support for people with a lower-leg amputation. Ultimately, the goal is to improve the quality of life for people living with a lower-leg amputation by addressing and preventing back pain.

Key takeaways

This study aims to understand why some amputees experience back pain.
It focuses on people with one lower-leg amputation.
Researchers will look at walking, muscles, and feelings over 12 months.
The goal is to improve future care for amputees with back pain.
You must be an adult with a recent prosthetic fitting to join.

Who may be eligible?

To be able to take part in this study, you need to be an adult, 18 years old or older. You must have had one leg amputated and be able to walk on flat ground. Importantly, you should have received your new prosthetic leg fairly recently, within the last three months after your amputation.

However, there are some reasons why you wouldn't be able to join. For example, if you have severe balance problems, or if you're unable to properly understand what it means to use a prosthetic leg and give your permission for its use. Also, if there are serious concerns about your remaining foot that would stop you from doing normal rehabilitation, or if your amputation was present from birth rather than happening later in life, you wouldn't be eligible. This study is also not for people who are transferring their care from a different clinic.

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?
Have you had one lower leg amputated?
Can you walk on flat ground?
Did you get your new prosthetic leg within the last 3 months?
Do you not have balance problems or very serious issues with your other foot?

Answer every question to see your result.

What does participation involve?

The specific details of what participating would involve are not fully described in the provided information. However, based on the study's aims, it's likely that you would need to attend several appointments over a 12-month period after getting your new prosthetic leg. These appointments would probably involve assessments of how you walk (your gait) and possibly measurements of your muscle activity in your back and remaining leg. You might also be asked questions about any pain you experience and how you are feeling generally. The study focuses on understanding rather than giving new medications or treatments. The total duration of your involvement would be for 12 months.

Potential risks and benefits

Taking part in research always has potential benefits and risks. A potential benefit of this study is that the information gathered could lead to better healthcare and rehabilitation programmes for people with lower-leg amputations in the future, helping to reduce back pain. There don't appear to be any serious medical risks involved, as the study focuses on observation and measurement rather than experimental treatments. However, you might find the assessments tiring or require some travel time. You are always free to change your mind and withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Bristol Centre for Enablement
Verified postcode
Bristol, United Kingdom
Portsmouth Enablement Centre
Verified postcode
Portsmouth, United Kingdom

Common questions

What is the main goal of this study?

The main goal is to understand why people with a lower-leg amputation develop lower back pain, so better care can be developed.

Who can take part in this study?

Adults over 18 who recently had one lower leg amputated, are able to walk, and have a new prosthetic leg.

What will I have to do if I join?

You'll likely have assessments of your walking and muscle activity over 12 months, and answer questions about your pain and wellbeing.

Will I receive any new treatment?

No, this study is about understanding and observing, not about giving new medications or experimental treatments.

How long will the study last for me?

If you take part, your involvement will be for 12 months after your amputation.

How to find out more

Official trial record

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