Pregabalin or Baclofen in Spastic Motor Behavior Treatment After SCI (PoBSCI), Prospective, Double-Blind, Randomised Drug Study
This research study is comparing two common medicines, pregabalin and baclofen, to see which is more effective at reducing severe muscle stiffness and spasms. These spasms can affect people who have recently had a spinal cord injury, ranging from complete to incomplete injuries in the neck or upper back. Patients in the study will take one of the medicines for 30 days. Researchers will then measure how much the muscle stiffness has improved. They will also look at how these medicines affect daily activities, independence, and overall quality of life. This is a "Phase III" trial, meaning it's a key step to confirm if a treatment is safe and effective.
At a glance
What is this study about?
This study, called PoBSCI, is looking for people who get severe muscle stiffness and spasms after a spinal cord injury. This stiffness, also known as spasticity, can make everyday movements very difficult. The study aims to compare two medicines, pregabalin and baclofen, which are already used to treat these kinds of symptoms. Both medicines work by affecting how signals are sent in your nervous system, which can help relax your muscles.
We know that living with muscle stiffness after a spinal cord injury can be really challenging. It can impact your ability to do things for yourself and reduce your overall well-being. By carefully comparing these two treatments, researchers hope to find out if one is clearly better than the other at reducing these difficult symptoms. This information could help doctors make more informed decisions when treating similar patients in the future.
The study is designed to be very thorough. Participants won't know whether they are receiving pregabalin or baclofen (and neither will their doctors), to make sure the results are as fair and unbiased as possible. Over 30 days, researchers will closely monitor how much the muscle stiffness improves, as well as checking on daily activities, how independent people are, and their general quality of life. This is an important step in confirming the best ways to help people recover and manage symptoms after a spinal cord injury.
Key takeaways
- Compares two medicines (pregabalin and baclofen) for severe muscle stiffness after spinal cord injury.
- Aimed at adults who recently had a spinal cord injury in the neck or upper back.
- Participants take one medicine for 30 days without knowing which one.
- Measures how well the medicines reduce stiffness and improve daily life.
- Helps doctors understand better how to treat these symptoms.
- Participation involves taking medication and attending assessments.
Who may be eligible?
To join this study, you must be an adult, aged 18 or over. There is no upper age limit.
You also need to have recently experienced a spinal cord injury, specifically one that affects your neck or upper back area (between C4 and T10). This injury can range from being 'complete' (meaning you have no feeling or movement below the injury) to 'incomplete' (meaning you have some feeling or movement).
Crucially, you must be experiencing severe muscle stiffness, spasms, or jerky movements due to your spinal cord injury. The study is specifically looking for people who are dealing with these significant motor behaviors.
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 recently had a spinal cord injury in your neck or upper back?
- Are you experiencing severe muscle stiffness, spasms, or jerky movements from your injury?
- Are you able to take daily medication for 30 days?
What does participation involve?
If you decide to take part, you will be given either pregabalin or baclofen to take as capsules or tablets every day for a total of 30 days. You won't know which medicine you're taking, and neither will your care team, to keep the study fair. During this month, you'll have regular check-ups where doctors will assess your muscle stiffness and spasms. They'll use special scales to measure how your symptoms are changing.
Besides these checks, you'll also be asked questions about your daily activities, how independent you feel, and your general quality of life. This will involve filling out some questionnaires. After the 30 days of treatment, there will be follow-up assessments to see how you are doing. The total time you would be involved in the study, including all treatments and check-ups, is relatively short, focusing mainly on that 30-day treatment period.
Potential risks and benefits
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Common questions
What is a 'spinal cord injury'?
A spinal cord injury happens when there is damage to the spinal cord, which is a bundle of nerves that carries messages between your brain and the rest of your body.
What does 'severe spastic motor behavior' mean?
This refers to very strong and uncontrolled muscle stiffness, spasms, or jerky movements that can happen after a spinal cord injury.
What are pregabalin and baclofen?
These are medicines commonly used to help reduce muscle stiffness and nerve pain by affecting how nerve signals are sent in the body.
Will I know which medicine I'm taking?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you're taking pregabalin or baclofen. This helps ensure the study results are fair.
How long will I be taking part in the study?
The main treatment period is 30 days, during which you'll take the study medicine. You'll also have assessments before, during, and after this time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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