RecruitingNAINTERVENTIONAL

Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis

This research trial aims to understand if osteopathy, a gentle hands-on treatment, can help people recover better after spinal fusion surgery for back pain. The study will compare two groups: one receiving osteopathy alongside standard physiotherapy, and another receiving a 'dummy' osteopathy treatment, also with physiotherapy. Researchers want to see if the real osteopathy can reduce pain and improve how well people can do everyday activities and their overall quality of life. This could help doctors understand if osteopathy is a good non-drug option for managing recovery after this type of back surgery. The study involves adults aged 18 to 75 who have recently had spinal fusion.

At a glance

Status

Recruiting

Phase

Sponsor

Clinique Bizet

Enrolment target

Start

02 Jan 2025

Estimated completion

01 May 2027

Chirurgical Intervention

What is this study about?

If you've had spinal fusion surgery for back pain, you know how important it is to get back to feeling your best. This study wants to find out if a treatment called osteopathy can help people recover more quickly and comfortably after this type of operation. Osteopathy is a hands-on therapy that focuses on how your body moves and works together. Osteopaths use various techniques, like massage, stretching, and gentle joint movements, to help ease pain and improve your body's natural healing.

The main goal of this research is to see if adding osteopathy to your usual physical therapy makes a difference. They will be comparing it to a "sham" osteopathy, which means a treatment that looks and feels like real osteopathy but doesn't have the same therapeutic effect. This helps the researchers determine if any improvements are genuinely due to the osteopathy itself, rather than just the attention or expectation of feeling better. The study hopes to provide clear answers on whether osteopathy can be a valuable tool for reducing pain and improving daily life after spinal fusion surgery.

Ultimately, the results of this study could help doctors and healthcare providers understand if osteopathy is a good option to recommend alongside other treatments for people recovering from spinal fusion. Finding non-drug ways to manage pain and improve recovery is always a priority, and this research aims to contribute to that understanding. It's about finding the best combination of care to help you get back to doing the things you love after surgery.

Key takeaways

This study investigates if osteopathy helps recovery after spinal fusion surgery.
It compares real osteopathy with a 'dummy' treatment.
Aims to improve pain and daily life for patients.
Participants will be aged 18-75 who recently had spinal fusion and ongoing back pain.
Results could offer a new non-drug option for post-surgery recovery.

Who may be eligible?

To be part of this study, you need to be an adult between 18 and 75 years old who has had spinal fusion surgery (one to three levels) about four weeks before the study starts. You also need to be experiencing some ongoing mechanical back pain from the surgery, rated at four or more out of ten on a pain scale.

There are also some reasons why you wouldn't be able to join. For instance, if your pain is mainly nerve-related (neuropathic pain), or if you have certain other conditions like fibromyalgia or algodystrophy. If you've had osteopathic treatment in the last three months, or if you're taking part in another research study at the same time, you won't be able to participate. They also can't include you if you have certain other serious medical or mental health conditions, apart from depression or anxiety.

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 75 years old?
Have you had spinal fusion surgery about four weeks ago?
Are you experiencing ongoing mechanical back pain (score of 4 out of 10 or higher)?
Have you not had osteopathic treatment in the last three months?
Are you not currently part of another clinical trial?
Do you not have nerve pain or certain other serious health conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups. One group will receive real osteopathy treatments in addition to physiotherapy, while the other group will receive a "sham" (or dummy) osteopathy treatment, also with physiotherapy. You won't know which group you're in, and neither will the therapists giving the main treatment.

The study will involve regular visits for your treatments and assessments. These assessments will involve answering questions about your pain levels and how well you can do daily activities, to track your progress and quality of life over time. The total duration of your participation in the study will depend on the treatment schedule, and this will be fully explained to you before you agree to join. You'll continue with any stable medications you're already taking.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving additional support for your recovery after spinal fusion surgery, and you might experience an improvement in your pain and quality of life. There's also the satisfaction of contributing to medical knowledge that could help future patients. As with any medical intervention, there could be some minor risks associated with the treatments, such as temporary soreness or discomfort, which will be fully explained. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Clinique Bizet
Verified postcode
Paris, France· Recruiting

Common questions

What is spinal fusion surgery?

Spinal fusion surgery is an operation where bones in your spine are joined together, often to reduce pain or instability.

What is osteopathy?

Osteopathy is a hands-on therapy that focuses on how your body moves. Therapists use techniques like massage and stretching to help ease pain and improve your body's function.

What does 'sham osteopathy' mean?

Sham osteopathy is a treatment that looks and feels like real osteopathy but doesn't have the same therapeutic effect. It helps researchers find out if the real treatment is truly making a difference.

Will I know if I'm getting real or sham osteopathy?

No, you won't know which group you're in. This is to ensure the results are fair and unbiased.

How long will the study last if I join?

The exact duration will be explained to you before you agree to join, as it depends on the treatment schedule for the study.

How to find out more

Bouchra benkessou, PM

b.benkessou@hexagone-sante-paris.fr 0033140693525 Official trial record

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