AuthorisedTherapeutic use (Phase IV)Interventional

BB trial; Effect of botox in Piriformis syndrome

This study, called the "BB trial," is investigating whether Botox (Botulinum Toxin Type A) can help people experiencing piriformis syndrome. This condition involves a tight piriformis muscle in the buttock, which can cause pain. The study will compare Botox injections to a simple saltwater injection (a placebo) to see if Botox is effective. Participants will be seen in a clinic 12 weeks after receiving their injection to check on their progress. This is a Phase IV study, meaning the treatment is already approved for other uses but researchers want to learn more about its effects specifically for piriformis syndrome. The study is open to adults aged 18 and over, regardless of gender.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Stichting Alrijne Zorggroep

Enrolment target

Start

30 Nov 2023

piriformis hypertonia

What is this study about?

You might be looking at this information because you or someone you know has piriformis syndrome. This is a condition where a muscle deep in your buttock, called the piriformis, becomes tight or inflamed. This can cause pain in your bottom, and sometimes it can even spread down your leg. Doctors sometimes refer to the muscle tightness as 'piriformis hypertonia'.

This research, called the 'BB trial', is trying to find out if a treatment called Botox (Botulinum Toxin Type A) can help ease these symptoms. Botox is a medicine that can relax muscles when injected. The study will compare Botox to a simple saltwater solution, which is sometimes called a placebo, to see if the Botox truly makes a difference. Thinking about it like this, if you're feeling unwell and take medicine, you want to know it's the medicine helping, not just that you'd have got better anyway or that you feel better because you expect to. The saltwater injection helps researchers understand this.

This is a specific type of study called a 'Phase IV' trial. This means that Botox is already approved and used for other medical conditions, but doctors want to learn more about its effects, especially for piriformis syndrome. The goal is to see if it's a safe and effective treatment option for this particular problem. Understanding this helps doctors offer the best care possible.

Key takeaways

This study investigates if Botox can help piriformis syndrome.
It compares Botox to a saltwater injection (placebo).
Participation involves one injection and a follow-up 12 weeks later.
The study is for adults aged 18 and over with piriformis syndrome.
Botox is already used for other conditions; this study is learning about it for piriformis syndrome.

Who may be eligible?

To take part in this study, you need to be an adult, meaning you must be 18 years old or older. There is no upper age limit, so older adults can also participate.

This study is open to both men and women. Your gender does not affect whether you can join.

The main requirement for joining is that you have piriformis syndrome, which is the condition the study aims to treat. If you've been diagnosed with piriformis syndrome, you might be suitable for 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?
Have you been diagnosed with piriformis syndrome?
Are you comfortable with receiving an injection?
Are you able to attend an outpatient clinic visit 12 weeks after the injection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive an injection. This will either be a small dose of Botox (Botulinum Toxin Type A) or a simple saltwater solution (physiological NaCl 0.9 %). You won't know which one you've received, and neither will the researchers, to ensure the results are fair.

The main follow-up for this study happens 12 weeks after you receive your injection. At this 12-week mark, you will have an appointment at an outpatient clinic. During this visit, the doctors will check to see how you are doing, ask about your symptoms, and assess if the treatment has made any difference. The total duration of your active participation in the study from the injection to this follow-up will be about 3 months.

Potential risks and benefits

Participating in research can have potential benefits, like access to a new treatment that might help your piriformis syndrome before it's widely available. However, there's no guarantee that you will receive the active treatment or that it will work for you. There are also potential risks involved with any injection, such as temporary pain, bruising, or a small risk of infection at the injection site. More rarely, Botox can have other side effects, although these would be discussed with you in detail. 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)

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

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Unverified
Netherlands

Common questions

What is piriformis syndrome?

It's a condition where a muscle deep in your buttock called the piriformis gets tight or inflamed, causing pain in your bottom and sometimes down your leg.

What is Botox?

Botox is a medicine that can relax muscles when injected. It's used for various medical conditions.

Will I get Botox or a saltwater injection?

You might get either Botox or a saltwater injection. Neither you nor the study team will know which you receive until after the study is complete, to ensure the results are unbiased.

How long will I be in the study?

After your single injection, you'll have a follow-up appointment about 12 weeks later. So, your active involvement will be around 3 months.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your medical care.