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Capsaicin patch trial targets nerve pain in lower back and legs

NCT ID NCT06540456

Symptom relief Sponsor: Medical University of South Carolina Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether Qutenza 8% capsaicin skin patches can safely and effectively treat nerve-related lower back pain and leg pain (sciatica). Fifty adults with symptoms lasting over three months will receive up to four patches per visit over five visits in a year. The main goal is to check for side effects and measure changes in pain and quality of life using surveys.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Qutenza 8% capsaicin topical system (skin patch)
What this could lead to
If it works, this could offer a new topical treatment option for people with nerve-related lower back and leg pain, potentially reducing pain and improving quality of life.
What could go wrong
This is a small, early pilot study with only 50 participants, so results may not apply to everyone. Capsaicin can cause skin irritation or burning at the application site.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients presenting to the Physical Medicine and Rehabilitation clinics at the Medical University of South Carolina outpatient clinics with complaints of lower back pain and radicular leg pain who meet all inclusion and exclusion criteria will be recruited.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Older than 18 years of age * Willing and have capacity to provide informed consent * History of symptoms for longer than three months (so as to minimize the chance of spontaneous recovery) * Pain-DETECT questionnaire (PD-Q) indicating neuropathic component of pain Exclusion Criteria: * Self-reported or medical records showing history of lumbar spine, hip, or lower extremity surgeries within three months * Chronic opioid use (determined by self-report and review of Prescription Drug Monitoring Program database) - defined as more than 15 morphine milligram equivalents (MME) per day for at least 2 weeks * Self-reported or medical records showing history of painful peripheral neuropathies (from diabetes mellitus, HIV, or induced by chemotherapy) * Self-reported allergies to study medications * Pregnant women (determined by self-report) and prisoners

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Conditions

The condition(s) this trial relates to.

Low Back Pain radiculopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lower back pain Lumbosacral radiculopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • MUSC Health Nexton Medical Park

    Summerville, South Carolina, 29483, United States

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