RecruitingNAINTERVENTIONAL

Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain

Living with long-term back pain can be challenging, and doctors often suggest a mix of treatments. This study aims to see if adding osteopathic treatment to the usual medical care can reduce pain for people in the UK experiencing chronic low back pain. Participants will be split into groups: one receiving usual medical care only, another receiving usual care plus a 'sham' (dummy) osteopathic treatment, and a third group receiving usual medical care combined with real osteopathic treatment. The main goal is to measure whether the group getting real osteopathic treatment, alongside their regular care, experiences a greater reduction in back pain after three months compared to the other groups. This research could help doctors understand the best ways to manage chronic low back pain.

At a glance

Status

Recruiting

Phase

Sponsor

Clinique Pasteur

Enrolment target

199

Start

02 Oct 2019

Estimated completion

01 Sep 2028

Chronic Low Back Pain

What is this study about?

Many people in the UK experience ongoing back pain, which can impact daily life. Doctors usually suggest a combination of treatments, including pain medications and various physical therapies like exercises or physiotherapy. Sometimes, they also recommend talking therapies to help manage the pain. Osteopathic treatment is a type of hands-on therapy used to diagnose and treat health problems, including back pain, by focusing on the body's natural ability to heal.

This study is designed to explore whether adding osteopathic treatment to the standard medical care for chronic (long-term) back pain can make a significant difference. It's about finding out if this combination of treatments helps people feel less pain. The researchers will be comparing different approaches: some people will get only their usual medical care, others will get usual care plus a special kind of 'dummy' osteopathic treatment, and a third group will receive their usual medical care alongside real osteopathic treatment. This helps researchers understand if any improvements are due to the actual osteopathic treatment itself.

The main thing the study wants to find out is if people who receive both classic medical care and osteopathic treatment have less back pain after three months compared to those who don't receive osteopathic treatment. By looking at these differences, the study hopes to provide clearer guidance on the most effective ways to manage chronic back pain, potentially leading to better outcomes for patients in the future.

Key takeaways

This study investigates if osteopathic treatment helps chronic back pain when combined with usual care.
Participants will receive usual medical care plus either real osteopathy, a dummy treatment, or no extra treatment.
The main goal is to see if combination therapy reduces back pain more effectively over three months.
It helps researchers understand better ways to manage long-term back pain.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to be between 18 and 64 years old and be experiencing ongoing, non-specific low back pain that has lasted for more than three months. This means your back pain isn't caused by a specific injury or condition like a recent fracture or nerve problem, but more general wear and tear or unknown causes. You also need to be registered with a social security scheme, which most people in the UK are.

There are certain reasons why you might not be able to join. For example, if your back pain is due to a specific condition like a serious nerve problem, an infection, a recent broken bone in your spine, or if you have metal implants in your spine, you wouldn't be eligible. Also, if you're currently taking strong pain medications like opioids or certain mental health medications, you wouldn't be able to participate. Pregnant or breastfeeding women, or those about to give birth, cannot join. If you're already part of another medical study or are considered a 'protected patient' (for instance, if you're under legal guardianship or hospitalised without your agreement), you also cannot 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 64 years old?
Have you had low back pain for more than 3 months, and it’s not due to a specific major injury or disease?
Are you currently registered with a social security scheme (e.g., pay National Insurance in the UK)?
Are you NOT pregnant, breastfeeding, or expecting to give birth soon?
Are you NOT currently taking strong pain medications like opioids or certain nerve-affecting drugs?
Are you NOT part of any other medical research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of three groups. One group will continue with their usual medical care for back pain. Another group will receive their usual medical care along with a 'sham' (dummy) osteopathic treatment, which feels like real treatment but isn't designed to have the same effects. The third group will get their usual medical care plus real osteopathic treatment. The study will involve regular assessments over three months to check how your pain levels are changing. You'll have visits to the study clinic for these assessments and to receive the assigned treatment, if applicable. The total duration of your active involvement in the study will be three months, during which time your pain levels will be closely monitored.

Potential risks and benefits

Taking part in a study like this offers potential benefits, such as contributing to our understanding of chronic back pain and potentially receiving a treatment that might help you. However, as with any medical intervention, there might be some risks or discomforts, though severe side effects from osteopathic treatment are rare. You'll be fully informed about any known risks before you decide to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Clinique Pasteur
Verified postcode
Toulouse, France· Recruiting

Common questions

What is osteopathic treatment?

Osteopathy is a health profession where practitioners use their hands to diagnose and treat problems with bones, muscles, joints, and ligaments.

What does 'chronic non-specific low back pain' mean?

This refers to ongoing back pain that has lasted for over three months and doesn't have a clear, specific cause like a recent injury or a particular disease.

Will I know which treatment group I'm in?

No, you will not know whether you are receiving real osteopathic treatment or the 'sham' (dummy) treatment. This helps ensure the study results are fair.

How long will I be involved in the study?

Your active involvement, including treatments and assessments, will last for three months.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, and your decision will not affect your medical care.

How to find out more

Barthélémy De Truchis de Varennes, MD

bdetruchis@clinique-pasteur.com + 33 5 62 21 35 36 Official trial record

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