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Preventing Neuropathic Pain After Osteoporotic Vertebral Fracture with a 5% Lidocaine Patch in Adults

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on people who have suffered a break in a spine bone caused by weakened bones, known as an Osteoporotic Fracture. After such a fracture, some individuals develop a type of pain that comes from damaged nerves, called neuropathic pain. The treatment being tested is a medicated plaster that releases a local anesthetic called lidocaine through the skin, applied once each day for a period of two months.

The purpose of the trial is to see whether the daily lidocaine plaster can lower the chance of developing neuropathic pain two months after the fracture. Participants are randomly assigned either the active plaster or a matching inactive plaster (placebo) and are asked to keep a simple diary of their use. During the study, they complete a short questionnaire (Pain Detect Questionnaire) that helps identify nerve‑related pain, and they attend a few visits to answer questions about their health.

In addition to checking for new pain, the study records any side effects and how well participants follow the daily routine. Pain levels are measured with a simple number scale, and overall well‑being is evaluated using a quality‑of‑life survey called the SF36 and a sleep quality survey known as the PSQI. The information gathered aims to show whether the lidocaine plaster is safe and useful for preventing nerve pain after a spine fracture.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and baseline assessment
After joining the study, you will sign the consent form and provide basic health information.
A baseline evaluation will be performed, including the pain detect questionnaire (a tool that scores pain symptoms, with a score of 19 or higher indicating neuropathic pain), a numeric pain scale (0 = no pain, 10 = worst pain), the sf36 quality‑of‑life questionnaire, and the psqi sleep questionnaire.
Step 2
Receive medication and instructions
You will be given versatis 700 mg patches, each containing 5% lidocaine applied to the skin (transdermal use).
The instructions will explain how to place one patch on an intact area of skin each day, how long to leave it on (typically 12 hours), and how to remove it safely.
You will also receive a daily logbook to record patch use, any side effects, and any other medicines taken.
Step 3
Daily application of the <b>lidocaine patch</b>
For the next 60 days (approximately 2 months), you will apply one patch each day as instructed.
The dose of lidocaine delivered by each patch is 700 mg, which corresponds to a 5% concentration.
Each day you will note in the logbook whether the patch was applied, the duration of wear, and any adverse effects such as skin irritation.
If you take other medications, you will record them in the logbook as well.
Step 4
Final evaluation after 2 months
At the end of the 60‑day period, you will return for a follow‑up visit.
The same assessments performed at baseline will be repeated: the pain detect questionnaire, the numeric pain scale, the sf36 quality‑of‑life questionnaire, and the psqi sleep questionnaire.
The study team will review your logbook for compliance and any adverse effects.
The primary outcome is whether neuropathic pain has developed, defined by a pain detect score of 19 or higher.
Step 5
Study completion
After the final evaluation, the study participation ends.
No further study‑specific visits are required unless medically indicated.

Who can join the trial?

5 criteria

Be a man or woman who is at least 50 years old and has been told they have osteoporosis (a condition that makes bones weak) by a rheumatologist (a doctor who treats bone and joint problems).
Have an osteoporotic vertebral fracture (a break in a spine bone caused by weak bones) that is less than 1 month old, as confirmed by the study doctor.
Experience pain at the fracture site that is scored 3 or higher on a numerical pain scale (where 0 means no pain and 10 means the worst possible pain).
Be able to understand the study and sign an informed consent form, which means agreeing to take part after learning what the study involves.
Be enrolled in a Social Security scheme (a government health or insurance program).

Who cannot join the trial?

9 criteria

If the doctor decides that your past medical or surgical problems do not fit with the study.
If you have a known hypersensitivity (allergy) to the active drug lidocaine or any other ingredient in the patch.
If you are allergic to other local anesthetics of the amide type, such as bupivacaine, etidocaine, mepivacaine, or prilocaine (these are medicines that numb an area).
If you are taking class I antiarrhythmic drugs (medicines that affect the heart’s rhythm) like tocainide or mexiletine, or any other local anesthetic medication.
If the skin where the patch would be placed is inflamed or damaged, for example active shingles lesions, dermatitis (skin irritation), or open wounds.
If you are pregnant or breastfeeding.
If you are already taking part in another clinical research study.
If you are under legal protection or are not free to make decisions (deprived of liberty).
If you choose not to take part in the study.

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Verified sites

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University Hospital Of Clermont-Ferrand
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Clermont Ferrand, France

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Investigated drugs

VERSATIS is a medicated plaster that contains lidocaine, a local anesthetic. It is applied to the skin like a small patch and slowly releases the medicine through the skin (transdermal use). In this study, participants placed the patch on the area of a recent osteoporotic vertebral fracture and wore it each day. The goal was to see whether the continuous, low‑dose lidocaine from the patch could lower the chance of developing neuropathic pain in the weeks and months after the fracture. The patch was the active treatment being tested, compared with other groups that did not receive this medication.

Lidocaine

What is already known about the treatment

Lidocaine patch - The lidocaine patch is a medicated plaster that you stick on the skin, delivering the drug through the skin (transdermal use). It is an approved medicine that is already used in many countries to treat nerve‑related pain such as post‑herpetic neuralgia, and it is being studied for preventing pain after osteoporotic vertebral fractures. The patch works by blocking sodium channels in nerve cells, which reduces the signals that cause pain. It belongs to the class of local anesthetic drugs.

Investigated diseases

Osteoporotic fracture - A break in a bone that occurs because the bone has become thin and weak from osteoporosis. It commonly affects the spine, hip, or wrist and may start with sudden or gradual pain after a minor fall or even normal activity. As the fracture heals, pain can increase and movement may become limited, often requiring rest and support. Because the underlying bone remains fragile, additional fractures can develop if the condition is not addressed. Healing may take longer than in healthy bone, and the fracture can lead to changes in posture or mobility over weeks to months.