RecruitingOBSERVATIONAL

Greater Occipital Nerve Block for Spontaneous Intracranial Hypotension

This study explores a potential new way to help people suffering from severe headaches due to a condition called Spontaneous Intracranial Hypotension (SIH). SIH happens when spinal fluid leaks, causing very painful headaches. Current treatments often involve long waits as they are specialist procedures. This study investigates if a simple injection in the neck, called a greater occipital nerve block, can temporarily relieve these headaches. This type of injection has helped with similar headaches before. Researchers want to see if it can also act as 'bridge therapy' for SIH patients, providing comfort and improving their daily lives while they await more definitive treatment for their spinal fluid leak. The study will track how much pain relief patients get and for how long.

At a glance

Status

Recruiting

Sponsor

University Health Network, Toronto

Enrolment target

Start

01 Aug 2024

Estimated completion

31 Dec 2027

Spontaneous Intracranial Hypotension

What is this study about?

Imagine your brain and spinal cord are cushioned by a special fluid. In a condition called Spontaneous Intracranial Hypotension (SIH), this fluid leaks out. When there isn't enough fluid, your brain can drop slightly, leading to very severe headaches, especially when you sit or stand up. These headaches can be very difficult to live with and have a big impact on daily life. Currently, the main treatment involves finding and sealing the leak, which often requires special procedures and can mean a significant waiting time.

While patients wait for these more permanent treatments, they can suffer a great deal. This study is looking into whether a simple injection, called a greater occipital nerve block (GONB), can offer some temporary relief. This injection is given in the back of the head/neck where a specific nerve is located. It has been shown to help with other types of headaches that are similar in nature to those experienced in SIH. The researchers believe it might also help ease the pain for SIH patients.

The idea is that this injection could act as a 'bridge therapy' – like a temporary fix – to make patients more comfortable and improve their quality of life during the waiting period for their main treatment. This particular type of injection is also easier to access as many doctors can perform it. By offering better pain control, patients might be able to get back to doing more of what they enjoy, and it could potentially help reduce the overall strain on healthcare.

Key takeaways

This study is for adults with severe headaches due to a spinal fluid leak (SIH).
It tests an injection in the neck for temporary pain relief.
The injection aims to help while patients await more permanent treatment.
It's a prospective observational study, meaning patients will be watched to see how they respond.
The injection might make daily life easier by reducing headache pain.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older, and have been diagnosed with Spontaneous Intracranial Hypotension (SIH) by a doctor. Your headache pain should also be moderate to severe (scoring more than 4 out of 10) when you are upright, meaning sitting or standing.

There are also some reasons why you might not be able to join. For example, if you have an active infection, either generally or at the injection site, or if you are allergic to any of the medicines used in the injection. If you take blood-thinning medications (other than aspirin) or steroids often, this study might not be suitable for you.

Also, if you are currently taking strong opioid pain medications (equivalent to 50mg or more of oral morphine daily), or if you have difficulty understanding or communicating, you wouldn't be able to participate. Finally, if you simply decide you don't want to take part, that's perfectly fine.

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 Spontaneous Intracranial Hypotension (SIH)?
Is your headache pain usually moderate to severe when you are sitting or standing up?
Do you have any active infections or allergies to local anaesthetics or steroids?
Are you taking certain blood-thinning medications (other than aspirin)?
Are you able to understand and communicate about the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would visit the Toronto Western Hospital Intracranial Hypotension Clinic. During your visit, you would receive a greater occipital nerve block (GONB) injection. This involves an ultrasound-guided injection into your neck, on both sides. The injection contains a mix of a local anaesthetic (to numb the area) and a steroid (to reduce inflammation).

After the injection, the researchers will closely monitor your headache intensity to see how it changes after 30 minutes. Over the next 14 days, you would continue to be monitored for changes in headache intensity, when your headache starts, how long you can sit up comfortably, any changes in other SIH symptoms, your emotional well-being, how satisfied you are with the treatment, and if you need to take other pain medications. They will also look for any side effects.

Potential risks and benefits

Taking part could offer some potential benefits, such as temporary relief from your severe headaches while you are waiting for more permanent treatments for your spinal fluid leak. This relief might improve your comfort and quality of life. As with any medical procedure, there are potential risks, though the greater occipital nerve block is generally considered safe. Risks can include temporary soreness, bruising, or a small infection at the injection site. Serious complications are rare. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Toronto Western Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is Spontaneous Intracranial Hypotension (SIH)?

SIH is a condition where spinal fluid leaks, causing severe headaches and other symptoms because there isn't enough fluid cushioning the brain and spinal cord.

What is a 'greater occipital nerve block'?

It's an injection given in the back of the head or neck near a specific nerve, often used to help relieve different types of headaches.

Why is this study being done?

The study wants to see if this injection can provide temporary relief for SIH headaches, acting as a 'bridge therapy' while patients wait for more permanent treatments.

Will this injection cure my SIH?

No, this injection is not expected to cure your spinal fluid leak. It aims to help manage your headache pain temporarily.

How long will the study follow me?

The study will track your symptoms and satisfaction for up to 14 days after the injection.

How to find out more

Anna Kalleitner, RN

anna.kalleitner@uhn.ca 416-603-5800 Official trial record

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