AuthorisedTherapeutic confirmatory (Phase III)Interventional

APICALE - Cervical facet injection of corticosteroids for the management of cervicobrachialgia : protocol for a randomized pilot study

This study, called APICALE, is looking into a treatment for neck and arm pain that spreads from the neck (cervicobrachial neuralgia). This condition can be very uncomfortable. The study will test if an injection of a steroid medication, Dexamethasone, into a specific area of the neck (cervical facet) can help reduce this pain. Researchers will compare it to a dummy injection (salt water) to see if the steroid is truly effective. They will track participants' pain levels, how well they can do daily activities, and their overall quality of life over three months. The aim is to find better ways to manage this type of pain.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

06 Mar 2026

Cervicobrachial Neuralgia

What is this study about?

Imagine you have persistent pain that starts in your neck and spreads down your arm – this is what healthcare professionals call cervicobrachial neuralgia. It can make everyday tasks difficult and impact your quality of life. Doctors sometimes use injections to help with this, and this study is looking closely at one type: a steroid injection in the neck.

The APICALE study wants to understand if an injection of a medicine called Dexamethasone, directly into a small joint in your neck (a cervical facet), can effectively reduce this neck and arm pain. To make sure the results are reliable, some people will receive the steroid, while others will receive a 'dummy' injection of salt water. This helps the researchers determine if any improvements are due to the medication itself, rather than just the act of having an injection.

The researchers will be carefully tracking participants' pain levels, their ability to move and do daily activities, and their overall well-being over a period of three months. This isn't just about pain relief; it's also about seeing if the treatment helps people get back to their normal lives, including their work. The information gathered from this study will help doctors understand if this particular injection is a good way to manage this type of pain in the future.

Key takeaways

Tests a steroid injection for neck and arm pain.
Compares steroid to a dummy injection to check effectiveness.
Participation involves injections and filling out questionnaires.
Study lasts for about three months.
Aims to improve pain management and daily quality of life.
Open to adults aged 18 and over with this specific type of pain.

Who may be eligible?

This study is welcoming adults aged 18 and over, both men and women, who are experiencing neck and arm pain that spreads from the neck, known as cervicobrachial neuralgia.

To be considered for the study, you'll likely need to meet specific health criteria that the doctors will discuss with you. These criteria are put in place to ensure the safety of participants and to make sure the study results are clear and meaningful. For example, they'll want to make sure your particular type of pain is what they are studying.

If you're interested, the study doctors will go through your medical history and current health with you. This will help them decide if this study is the right fit for you and if it's safe for you to take part.

Quick self-check

Are you 18 years old or older?
Do you have chronic neck and arm pain that spreads from your neck?
Are you willing to attend several appointments over three months?
Are you comfortable filling out questionnaires about your pain and well-being?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, it would involve several visits over about three months. At the start, you would have an injection in your neck – either the study medication (steroid) or a dummy injection (salt water). You wouldn't know which one you received. You would be asked to keep track of your pain levels using a simple rating scale, from 0 to 100, where 0 is no pain and 100 is the worst pain imaginable. You'd also complete questionnaires about your neck pain, how it affects your daily activities, and your general quality of life. These questionnaires would be done at different times: at 15 days, and then at 1, 2, and 3 months after your injection. The study will also track if you need to take any pain relief medicines and if you experience any side effects. The total duration of your active participation, including follow-up, would be around three months.

Potential risks and benefits

Taking part in a study like this could potentially help you find relief from your neck and arm pain, or it could help future patients by providing valuable information about this treatment. However, there are also potential risks, as with any medical procedure. Injections carry a small risk of discomfort, bruising, infection, or other side effects. You will be closely monitored for any adverse events throughout the study. Remember, participation is completely voluntary; you have the right to withdraw from the study at any time without giving a reason, and this decision will not affect your usual medical care.

Locations (1)

—
France

Common questions

What kind of pain is this study looking at?

This study is for neck and arm pain that spreads from the neck, called cervicobrachial neuralgia.

What is the injection made of?

You would receive either an injection with a steroid medicine called Dexamethasone, or a salt water (placebo) injection.

How long will I be in the study?

Your active participation, including follow-up, would last for about three months.

Will I know if I get the real medicine or the dummy injection?

No, you won't know which injection you receive. This helps to ensure the study results are unbiased.

Can I stop participating if I want to?

Yes, you are free to leave the study at any time without it affecting your medical care.