RecruitingNAINTERVENTIONAL

Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)

This study, called SAHARA, is testing a new way for people to recover after a common type of back surgery called lumbar arthrodesis. This surgery is becoming more common, and patients usually need physiotherapy to help them get moving again. However, sometimes it's hard to get to a physiotherapist right away. Researchers want to find out if doing specific exercises at home soon after surgery is just as good, or even better, than waiting to see a physiotherapist a few weeks later. The main goal is to see if these home exercises can help reduce back pain and improve patients' overall quality of life much sooner after their operation.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

120

Start

18 Dec 2023

Estimated completion

01 Oct 2028

Spondylolisthesis, Lumbar Region

What is this study about?

Back surgery, specifically something called lumbar arthrodesis, is becoming more frequent as people get older. This operation helps to stabilise parts of your lower back. After this type of surgery, it's really important for people to start moving and doing exercises quite early on, even if they don't have any major problems with their leg movement. We know that getting active early can help strengthen muscles and reduce back pain.

This study wants to compare two different ways of helping people recover. The usual way means patients wait about 4 to 6 weeks after surgery before they start seeing a physiotherapist. The new way being tested involves patients learning special exercises from a physiotherapist while they're still in hospital, and then doing these exercises at home themselves, starting right after they get home from surgery.

The main thing we want to find out is whether doing these home exercises straight away helps to reduce back pain more effectively at 6 weeks and 3 months after surgery, compared to the usual approach. We will also look at how much patients' ability to do everyday activities improves, and how well they can move their hips and legs.

Key takeaways

Compares early home exercises vs. later physio for back surgery recovery.
Aims to reduce pain and improve life quality faster after surgery.
Participants will be randomly assigned to one of two rehabilitation groups.
Follow-up appointments at 6 weeks and 3 months after surgery.
Suitable for adults having specific lower back surgery for ongoing pain.

Who may be eligible?

To be part of this study, you would need to be an adult, aged 18 or over, who is having specific lower back surgery (called posterolateral lumbar arthrodesis). This surgery would be for back pain or nerve pain in your leg that hasn't gotten better with other treatments.

It's important that you don't have any major weakness in your legs before or after the surgery. Also, you should be able to go home after your operation, and your doctor should agree that it's safe for you to start gentle exercises on your own quite soon after surgery. You'll also need to understand and sign a consent form before your operation.

There are some reasons why you wouldn't be able to join. For example, if you're pregnant or breastfeeding, if you have certain mental health or brain conditions, or if you have complications after surgery that mean you have to stay in hospital longer. If you have any new, severe leg weakness after surgery, you also wouldn't be able to continue in the study.

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?
Are you having specific lower back surgery for back or nerve pain?
Do you have no significant leg weakness before or after surgery?
Can you return home soon after your operation?
Are you able to understand and sign a consent form?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly put into one of two groups. One group will learn how to do exercises at home from a physiotherapist while in hospital and start these exercises shortly after surgery. The other group will follow the usual practice of seeing a physiotherapist 4 to 6 weeks after surgery.

Regardless of your group, you will have follow-up appointments with your surgeon and a physiotherapist at 6 weeks and 3 months after your surgery. These appointments will assess your pain levels, how well you're moving, and your general recovery. There is no special medication involved in this study; it's about different approaches to rehabilitation. The total duration of your active participation in the study, where we collect information, would be 3 months after your surgery.

Potential risks and benefits

Participating in this study might offer the benefit of potentially reducing your back pain and improving your recovery sooner than the standard care, especially if you are in the group doing early home exercises. You would also have regular check-ups with your medical team. As with any medical study, there's always a chance that the new approach might not be better, or perhaps not as effective, as the standard treatment for some individuals. There are no known additional risks from the rehabilitation itself beyond what you would expect from standard post-surgical exercises. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

AP-HP - Hôpital Européen Georges-Pompidou Paris, France
Verified postcode
Paris, France· Recruiting

Common questions

What is 'lumbar arthrodesis'?

It's a type of back surgery that joins together bones in your lower spine to make them stable and reduce pain.

What does 'self-rehabilitation' mean?

It means doing exercises and stretches at home by yourself, usually after being taught by a professional like a physiotherapist.

Will I be able to choose which group I'm in?

No, you will be put into one of the two groups randomly, like flipping a coin. This helps make the study fair.

How long will the study last for me?

We will follow up on your recovery for about 3 months after your operation.

What if I can't do the home exercises?

Your medical team will discuss this with you. Your safety and recovery are always the priority.

How to find out more

Breno MELO, PhD

gestion-locale.drc@aphp.fr (0)140271988 Official trial record

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