AuthorisedTherapeutic confirmatory (Phase III)Interventional

EFFICACY OF USUAL MANAGEMENT BY LOCAL ANESTHETIC INFILTRATION IN THE TREATMENT OF CHRONIC IDIOPATHIC ANO-PERINEAL PAIN: A RANDOMIZED DOUBLE-BLIND -CONTROLLED TRIAL

This study is looking into a common problem: ongoing pain in the lower back and bottom area that doesn't have a clear cause. We want to see if injecting a local anaesthetic, similar to what a dentist uses, can help reduce this pain. Participants will receive either the anaesthetic or a plain salt water solution injection. This is a "blinded" study, meaning neither you nor your doctor will know which injection you're getting, to ensure fair results. We will be comparing how well each injection works by measuring pain levels one month after the first treatment. We also want to see if any pain relief lasts longer than that.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Groupe Hospitalier Diaconesses Croix Saint Simon

Enrolment target

Start

11 Dec 2024

chronic idiopathic ano-perineal pain

What is this study about?

This research study is investigating treatments for chronic idiopathic ano-perineal pain. This is a medical term for ongoing pain in the lower back, bottom, and surrounding area that doesn't have a clear reason or cause. We understand how disruptive and upsetting this kind of pain can be, and currently, finding effective long-term solutions can be challenging.

In this study, we are focusing on a treatment approach that involves injections of a local anaesthetic. A local anaesthetic is a type of medicine that temporarily numbs an area of your body to block pain signals. You might have received a similar injection at the dentist. We want to compare this anaesthetic injection to a 'dummy' injection, which is a salt water solution (like saline). This comparison helps us understand if the anaesthetic itself is truly making a difference, beyond any effect that simply getting an injection might have.

Our main goal is to find out if the anaesthetic injection can reduce your pain significantly—by at least 3 points on a pain scale—one month after your first injection, compared to the salt water injection. We'll also be checking to see if any pain relief lasts for three months, if the pain completely goes away for some people, and how the treatments affect your daily life, anxiety, and general well-being.

Key takeaways

Tests local anaesthetic injections for unexplained chronic pain in the lower back/bottom.
Compares it to a plain salt water (saline) injection.
Aims to see if pain reduces significantly after one month.
Also checks for longer-term pain relief and impact on daily life.
Study is 'double-blind' for fair results.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. Both men and women can take part. The most important requirement is that you experience ongoing pain in your lower back, bottom, and genital area that doesn't have a known cause.

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 experience ongoing pain in your lower back, bottom, or genital area?
Has a doctor told you that the cause of this pain is unknown?
Are you able to attend appointments for injections and follow-up checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive an injection of either the local anaesthetic or a salt water solution. Neither you nor your doctor would know which one you received. You would have your pain levels checked before the injection and again one month and three months afterwards using a special pain scale. You would also fill out some questionnaires about how your pain affects your daily life, your mood, and other aspects of your health. The total duration of your active participation, including follow-up, would be approximately three months.

Potential risks and benefits

You might experience some benefits, such as a reduction in your pain, if the local anaesthetic is effective for you. Even if you receive the salt water injection, sometimes the act of having an injection can provide some temporary relief. However, there are potential risks associated with injections, such as temporary discomfort, bruising, or a small risk of infection at the injection site. It's also possible that the treatment may not improve your pain at all. You are free to withdraw from the study at any time, for any reason, without it affecting 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
France

Common questions

What kind of pain is this study for?

This study is for ongoing pain in the lower back, bottom, and genital area that doctors haven't been able to find a clear cause for.

What is a 'local anaesthetic'?

It's a medicine that numbs a specific part of your body to block pain, similar to what a dentist uses.

What does 'double-blind' mean?

It means neither you nor your doctor will know whether you are receiving the active drug or the salt water injection. This helps make the study results more reliable.

How long will I be involved in the study?

You'll be involved for about three months, including follow-up appointments to check your pain and well-being.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without having to give a reason, and it won't affect your future medical care.