EFFICACY AND SAFETY OF LOCAL TREATMENT OF TRAPEZIUS MYOFASCIAL SYNDROME IN PATIENTS WITH FIBROMYALGIA THROUGH ULTRASOUND-GUIDED INTERFASCIAL BLOCK OF THE TRAPEZIUS MUSCLE
This research is testing a specific treatment for ongoing neck and shoulder pain, often experienced by people with fibromyalgia. This pain is linked to the trapezius muscle, located in the upper back and neck. Researchers will use an ultrasound machine to guide an injection of medicine directly into the muscle area that is causing pain. The study wants to see if this method is effective at reducing pain and if it is safe to use. It will also look at how this treatment might affect a person's general pain, tiredness, sleep, daily activities, and overall well-being. The study plans to follow people for 12 weeks to see the short-term effects of the treatment.
At a glance
What is this study about?
This study is investigating a particular type of pain called "trapezius myofascial syndrome" in people who also have fibromyalgia. In simple terms, this means ongoing pain and tenderness in the trapezius muscle, which is a large muscle in your upper back and neck. For people with fibromyalgia, this specific muscle pain can add to their overall discomfort.
The researchers are testing a technique where they use a special scan, similar to the scans used during pregnancy (an ultrasound), to precisely guide an injection. This injection delivers tiny amounts of medicine directly into the painful area of the trapezius muscle. The aim is to see if this targeted injection can effectively reduce the muscle pain. They will be using different types of medicines, including one that reduces swelling (like Kenacort), and others that numb the area (like Lidocaine or Bupivacaine) or are a simple salt solution.
The main goal is to find out if this treatment significantly reduces the neck and shoulder pain. They will also be looking at other important aspects of a person's health, such as their general pain levels, how tired they feel, how well they sleep, their ability to do daily tasks, and their overall quality of life. This is a "Phase IV" study, which means the medicines involved are already approved for use, but researchers are looking at new ways to use them for specific conditions, or gathering more information about their effects in a real-world setting.
Key takeaways
- Tests targeted injections for neck/shoulder pain in fibromyalgia.
- Uses ultrasound to guide precise medicine delivery.
- Looks at pain, fatigue, sleep, and quality of life.
- Medicines involved are already approved for other uses.
- Study duration is 12 weeks.
Who may be eligible?
To join this study, participants must be at least 18 years old. There is no upper age limit, so adults of many ages can take part. Both men and women are welcome to participate in this research.
The most important thing is that participants must have fibromyalgia and be experiencing pain in their trapezius muscle (in the neck/shoulder area) that is suitable for this type of focused treatment. The research team will do checks to make sure your specific condition fits the study's requirements.
There might be other health conditions or medications that would prevent someone from joining, but these will be discussed in detail by the study doctor to ensure it's safe for you.
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?
- Do you have a diagnosis of fibromyalgia?
- Are you experiencing ongoing pain in your neck and shoulder area (trapezius muscle)?
- Are you suitable for an injection directly into a muscle?
What does participation involve?
If you decide to take part in this study, you would have several visits to the clinic over a period of 12 weeks. During these visits, you would receive the guided injection into your trapezius muscle by a doctor using an ultrasound machine. This machine helps them see exactly where to place the needle.
You would be asked to regularly rate your pain using a simple scale, usually from 0 (no pain) to 10 (worst possible pain). You would do this for your neck/shoulder pain specifically, as well as your general pain. You'll also answer questions about how tired you feel, how well you sleep, your ability to do daily activities, and your overall quality of life. Some measurements might involve checking sensitive points on your body with a special device. The study will track these things at different times, specifically at 2, 4, and 12 weeks after your treatment.
Potential risks and benefits
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Common questions
What is the trapezius muscle?
It's a large muscle in your upper back and neck, shaped like a trapezoid, that helps you move your head and shoulders.
What does 'ultrasound-guided' mean?
It means the doctor uses a special scan, like the ones babies are checked with, to see inside your body and guide the needle precisely.
What kind of medicines are being injected?
They're using a mix, including a steroid to reduce swelling, and local anaesthetics (numbing medicines) to relieve pain.
How long does the study last?
The study involves tracking your progress for 12 weeks after the treatment.
Will I know if I'm getting the active medicine or something else?
This study is testing different approaches, and the research team will explain whether you will know what treatment you are receiving.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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