RecruitingNAINTERVENTIONAL

The METRIC Study Protocol

This research, called The METRIC Study, is exploring how spinal manipulation therapy helps people with long-term lower back pain that has lasted for at least six months. The main goals are to find out if this therapy reduces a specific type of pain signal in the body and if treating the whole spine is more effective than only treating the lower back. Researchers also want to see if more frequent treatments over a longer period lead to better results. Participants will receive either spinal manipulation therapy targeted to their needs or a control treatment. A group of healthy volunteers will also be involved for comparison. This study could help us better understand how spinal manipulation works and how to best use it for lower back pain.

At a glance

Status

Recruiting

Phase

Sponsor

Université du Québec à Trois-Rivières

Enrolment target

112

Start

25 Oct 2023

Estimated completion

31 Dec 2026

Chronic Low-back Pain

What is this study about?

This study, called The METRIC Study, is investigating a common problem: long-term lower back pain. If you've had lower back pain for six months or more, you know how much it can affect your daily life. This research aims to understand how a type of hands-on treatment, called spinal manipulation therapy, might help. Think of it as a way to gently adjust your spine, and researchers want to see if these adjustments can reduce the pain signals your body sends.

Specifically, the study is asking a few important questions. Does spinal manipulation reduce certain pain signals in the body? Is it more effective to treat the entire spine when needed, or just focus on the lower back area? And importantly, does having more treatments over a longer time (like 36 treatments over three months) work better than fewer treatments (like 12 treatments over one month)? By answering these questions, the study hopes to improve how we treat long-term lower back pain.

To figure this out, some participants will receive targeted spinal manipulation, while others will have a control treatment. There will also be a group of healthy volunteers who don't have back pain, and their information will help the researchers compare results. The findings from this study could help doctors and therapists provide better, more effective treatments for people experiencing ongoing lower back pain.

Key takeaways

Researches spinal manipulation for long-term lower back pain.
Aims to understand how pain is reduced by the therapy.
Compares whole spine vs. lower back only treatment.
Investigates benefits of more frequent treatments over time.
Involves regular assessments and questionnaires.
Requires back pain for at least 6 months and ability to speak French.

Who may be eligible?

To join this study, your lower back pain must have lasted for at least six months and be at least a moderate level (meaning a score of 3 out of 10 or higher). You need to be between 18 and 60 years old. There's also a group for healthy volunteers who don't have back pain, and they will be matched by age and sex to participants with back pain.

You cannot take part if your back pain is caused by other specific conditions, such as a slipped disc, severe arthritis, or if you've had spinal surgery. You also can't participate if you have numbness, weakness, or other nerve problems, or if you have pain in another part of your body that is worse than your back pain. Certain medical conditions like active cancer, severe osteoporosis, or inflammatory arthritis would also prevent you from joining, as would being pregnant or planning to get pregnant soon.

Additionally, you shouldn't have had spinal manipulation in the last year, and certain other health conditions like diabetes affecting your nerves, some mental health disorders, or drug/alcohol dependence would exclude you. If you have any ongoing legal claims for back pain or are receiving disability payments related to it, you would also not be able to join. For healthy volunteers, you shouldn't be taking pain medication regularly or in the 48 hours before tests, or have a history of ongoing pain.

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.

Do you have lower back pain that has lasted for at least 6 months?
Is your average lower back pain level at least 3 out of 10?
Are you between 18 and 60 years old?
Do you NOT have a serious back condition like a slipped disc or severe arthritis?
Have you NOT had spinal manipulation in the last 12 months?
Can you understand and complete questionnaires in French?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be assigned to either receive spinal manipulation therapy (which could be to your lower back only or your whole spine, depending on what's clinically indicated) or a control treatment. The treatment schedule will vary, with some groups having 36 treatments over three months and others 12 treatments over one month.

Throughout the study, you'll have various assessments to measure your pain levels and other body responses. These will include filling out questionnaires. For some parts of the study, there will be assessments to look at specific pain signals in your body. It's important to be able to understand and respond to questionnaires in French. Healthy volunteers will also have regular visits and assessments over the same time period as the other participants. The total duration of your involvement will depend on which group you are in, ranging up to three months of treatments and follow-up.

Potential risks and benefits

Taking part in this study could potentially help you understand your chronic lower back pain better, and you might experience a reduction in your pain through the spinal manipulation therapy. You would also be contributing valuable information that could help others with similar conditions in the future. As with any treatment, there are potential risks associated with spinal manipulation, such as temporary soreness or stiffness, though serious complications are rare. All procedures will be explained in detail, and your safety is important. Remember, participating is entirely 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)

Université du Québec à Trois-Rivières
Verified postcode
Trois-Rivières, Canada· Recruiting

Common questions

What is spinal manipulation therapy?

It's a hands-on treatment where a trained professional uses their hands to apply controlled, sudden force to a spinal joint. This is done to improve movement and reduce pain.

How long will the study last if I take part?

Depending on which treatment group you are in, your active participation could last for either one month or three months, including follow-up assessments.

Will I definitely receive active spinal manipulation?

Participants will be assigned to either receive spinal manipulation therapy or a control treatment, which won't be active manipulation. You won't know which group you are in until after the study is complete to avoid influencing the results.

What is 'chronic primary low back pain'?

This means lower back pain that has lasted for six months or more and doesn't have a clear, specific cause like an injury or underlying disease.

Do I need to be able to speak French?

Yes, you need to have sufficient French language skills to be able to understand and complete the questionnaires used in the study.

How to find out more

Benjamin Provencher

metric@uqtr.ca 1-819-376-5011 Official trial record

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