Lower Back PainNCT06540456
Qutenza 8% Capsaicin Topical System for the Treatment of Neuropathic Axial Lower Back Pain and Lumbosacral Radiculopathy
An observational study of Lower Back Pain and Lumbosacral Radiculopathy, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This is a research study to find out if Qutenza 8% capsaicin topical system is safe and effective when treating subjects with lower back pain (LBP) that is caused by damage at or near the nerve's root in the lower back leg (lumbosacral radiculopathy) which is pain that can move all the way down the back of the leg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Back Pain, Lumbosacral Radiculopathy
- What is being tested?
- Qutenza® 8% Capsaicin Topical System
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2025to 3 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
MUSC Health Nexton Medical Park
Summerville, South Carolina, 29483
About this study
Official title: Qutenza 8% Capsaicin Topical System for the Treatment of Neuropathic Axial Lower Back Pain and Lumbosacral Radiculopathy: A Prospective Study.
This is a research study to find out if Qutenza 8% capsaicin topical system is safe and effective when treating subjects with lower back pain (LBP) that is caused by damage at or near the nerve's root in the lower back leg (lumbosacral radiculopathy) which is pain that can move all the way down the back of the leg. The pain may also start outside of the spinal cord, in the peripheral nerves and may also be felt all the way down the back of the leg (neuropathic LBP). Qutenza 8% capsaicin, the study drug, is currently FDA approved to treat nerve pain after a shingles outbreak in addition to a type of nerve pain in the feet associated with diabetes. In this study a maximum of four patches per visit (sized 14cm x 20 cm) will be used to deliver the Qutenza 8% capsaicin to the participants skin.
If a subject meets the qualifications for this study, in addition to their standard of care for their LBP, they can expect to have a total of 5 visits in a 12 month period. Each visit will require subjects to fill out several surveys and receive treatment patches for their LBP (your doctor will decide if participants will need to be retreated at each visit based on your symptoms). The study visits are estimated to take 90 minutes upwards to 120 minutes.
Read the detailed description
Chronic lower back pain (LBP) and lumbosacral radiculopathy are common, disabling, and costly conditions. The lifetime prevalence of LBP is estimated to be greater than 70% in industrialized countries, with a 1-year prevalence of 15-45% and LBP is the most common cause of years lived with disability worldwide. Chronic LBP (defined as LBP lasting less than 3 months) is a complex and heterogeneous condition with nociceptive and neuropathic components.
The goals of treatment of chronic LBP and lumbosacral radiculopathy are to reduce pain, maintain function, and prevent future exacerbation. Guidelines advocate for a multimodal approach to the management of these conditions, combining pharmacological therapies for symptomatic relief with nonpharmacological approaches, such as physical rehabilitation. Choice of treatment is individualized according to the nature and severity of symptoms, the presence of comorbid conditions, potential for adverse effects and drug interactions, and cost. At this time, there are no specific recommendations for treatment of the neuropathic components of chronic LBP and neuropathic pain medications for painful radiculopathy have limited response rates. Furthermore, current pharmacologic approaches for the treatment of neuropathic pain are associated with a risk of significant adverse effects, which can have a serious impact on patients' quality of life. As such, there is a pressing need for safe and effective therapeutic options in treating neuropathic LBP and painful lumbosacral radiculopathy.
Capsaicin is the main compound in chili peppers and acts mechanistically as a selective agonist of the transient receptor potential vanilloid 1 (TRPV1) channel, which is highly expressed on nociceptors. High concentrations of capsaicin have been effectively utilized for the treatment of neuropathic pain. Additionally, whereas many pharmacologic and interventional pain relief options for chronic LBP and radiculopathy cause weight gain, capsaicin has been widely studied for its weight loss potential.
Emerging evidence suggests the use of topical capsaicin may be a safe and efficacious treatment for chronic LBP and radiculopathy. With regards to LBP, a 2010 double-blind multi-center randomized clinical trial on the use of 0.05% topical capsaicin cream for the treatment of chronic LBP demonstrated a significantly higher number of patients experiencing at least 50% pain sum score improvement at 3 weeks compared to placebo. A 2016 open-label study of 90 patients with lumbosacral neuropathic pain who received treatment with a topical 8% capsaicin patch found statistically significant reductions in pain at 2, 8, and 12 weeks follow-up. With regards to lumbosacral radiculopathy, a 2017 randomized controlled trial of 50 participants with chronic lumbosacral radiculopathy treated with a topical 8% capsaicin patch found at least a 30% improvement of pain in 71.4% and 39.1% of patients with 3 months to 2 years duration of pain and greater than 2 years duration of pain, respectively. A prospective study investigating the use of a single 8% capsaicin patch in patients with a variety of neuropathic pain conditions, including radiculopathy noted that the proportions of patients achieving a 30% and 50% decrease in pain at 12 weeks were 43% and 24%, respectively. Additionally, a small retrospective analysis of patients with painful radiculopathy found that the capsaicin 8% patch provided rapid and sustained pain relief, with a significant reduction in prescribed concomitant pain medications. In brief, the current literature is limited by small sample sizes and short follow up periods but does suggest topical capsaicin is a rational choice for the treatment of neuropathic lumbosacral pain.
The neuropathic components in chronic LBP and lumbosacral radiculopathy may be under-recognized and therefore undertreated. Most clinical trials of drug treatments for neuropathic pain have examined patients with Postherpetic neuralgia or painful diabetic peripheral neuropathy, and the extent to which results of these studies can be extrapolated to other neuropathic conditions is unknown. Use of the Qutenza (8% capsaicin) topical patch for the treatment of chronic LBP and lumbosacral radiculopathy holds great promise to improve the pain and function of patients suffering with these common and debilitating conditions, which in turn has the potential for tremendous economic impact.
- Conditions
- Lower Back Pain, Lumbosacral Radiculopathy
- Being tested
- Qutenza® 8% Capsaicin Topical System
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qutenza® 8% Capsaicin Topical SystemDrug
Treatment of patients with neuropathic LBP and painful lumbosacral radiculopathy using the Qutenza 8% capsaicin topical system.
| Study group | Role | What they receive |
|---|---|---|
| Patients with neuropathic LBP and painful lumbosacral radiculopathy | patients with neuropathic LBP and painful lumbosacral radiculopathy Receives: Drug: Qutenza® 8% Capsaicin Topical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse effects as assessed by routine patient monitoring of subjects treated with Qutenza 8% capsaicin topical system for LBP and lumbosacral radiculopathy
The primary aim of this pilot study is to assess whether the Qutenza 8% capsaicin topical system is an effective treatment for neuropathic lower back pain and painful lumbosacral radiculopathy as based on PROMIS-29 scores for pain and quality of life. Safety will be determined by the number of participants with treatment-related adverse events as assessed by routine clinical monitoring
Measured: at 12 months
Secondary outcomes (3)
Assess changes in body mass index (BMI) in patients receiving the Qutenza 8% capsaicin topical system.
A secondary aim is to assess side effects, weight (measured in kg) and height (measured in meters) will be combined to report changes in BMI in kg/m^2 at each subsequent follow-up visit of patients receiving the Qutenza 8% capsaicin topical system.
Measured: at 12 months
Assess changes in quality of life and sleep in patients receiving the Qutenza 8% capsaicin topical system.
A secondary aim is to assess the quality of life and sleep data will be obtained from the PROMIS 29 subscales
Measured: at 12 months
Assess changes in medication and procedural utilization in patients receiving the Qutenza 8% capsaicin topical system.
A secondary aim is to assess medication and procedural (lumbar and sacral interventions, including sacroiliac joint injections or radiofrequency ablations, lumbar facet joint injections or radiofrequency ablation, and lumbar or sacral epidural steroid injections) utilization, which will be determined by patient's self-report interview or chart review at each subsequent follow-up visit of patients receiving the Qutenza 8% capsaicin topical system.
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start13 Mar 2025
- Primary completion3 Jul 2027 (estimated)
- Study completion3 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Averitas Pharma, Inc.
- Responsible party
- Principal investigator, Matthew Sherrier, Medical University of South Carolina
- Investigators
- Matthew Sherrier, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540456
- Sponsor's protocol ID
- Pro00134392
- Status last verified
- Mar 2026
- First submitted
- 28 Jun 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qutenza 8% Capsaicin Topical System for the Treatment of Neuropathic Axial Lower Back Pain and Lumbosacral Radiculopathy: A Prospective Study.
- ClinicalTrials.gov ID
- NCT06540456
- Acronym / sponsor ID
- Pro00134392
- Conditions
- Lower Back Pain, Lumbosacral Radiculopathy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Averitas Pharma, Inc.
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 3 Jul 2027 (estimated)
- Study completion
- 3 Jul 2028 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to find out if Qutenza 8% capsaicin topical system is safe and effective when treating subjects with lower back pain (LBP) that is caused by damage at or near the nerve's root in the lower back leg (lumbosacral radiculopathy) which is pain that can move all the way down the back of the leg. The pain may also start outside of the spinal cord, in the peripheral nerves and may also be felt all the way down the back of the leg (neuropathic LBP). Qutenza 8% capsaicin, the study drug, is currently FDA approved to treat nerve pain after a shingles outbreak in addition to a type of nerve pain in the feet associated with diabetes. In this study a maximum of four patches per visit (sized 14cm x 20 cm) will be used to deliver the Qutenza 8% capsaicin to the participants skin.
If a subject meets the qualifications for this study, in addition to their standard of care for their LBP, they can expect to have a total of 5 visits in a 12 month period. Each visit will require subjects to fill out several surveys and receive treatment patches for their LBP (your doctor will decide if participants will need to be retreated at each visit based on your symptoms). The study visits are estimated to take 90 minutes upwards to 120 minutes.
Detailed description
Chronic lower back pain (LBP) and lumbosacral radiculopathy are common, disabling, and costly conditions. The lifetime prevalence of LBP is estimated to be greater than 70% in industrialized countries, with a 1-year prevalence of 15-45% and LBP is the most common cause of years lived with disability worldwide. Chronic LBP (defined as LBP lasting less than 3 months) is a complex and heterogeneous condition with nociceptive and neuropathic components.
The goals of treatment of chronic LBP and lumbosacral radiculopathy are to reduce pain, maintain function, and prevent future exacerbation. Guidelines advocate for a multimodal approach to the management of these conditions, combining pharmacological therapies for symptomatic relief with nonpharmacological approaches, such as physical rehabilitation. Choice of treatment is individualized according to the nature and severity of symptoms, the presence of comorbid conditions, potential for adverse effects and drug interactions, and cost. At this time, there are no specific recommendations for treatment of the neuropathic components of chronic LBP and neuropathic pain medications for painful radiculopathy have limited response rates. Furthermore, current pharmacologic approaches for the treatment of neuropathic pain are associated with a risk of significant adverse effects, which can have a serious impact on patients' quality of life. As such, there is a pressing need for safe and effective therapeutic options in treating neuropathic LBP and painful lumbosacral radiculopathy.
Capsaicin is the main compound in chili peppers and acts mechanistically as a selective agonist of the transient receptor potential vanilloid 1 (TRPV1) channel, which is highly expressed on nociceptors. High concentrations of capsaicin have been effectively utilized for the treatment of neuropathic pain. Additionally, whereas many pharmacologic and interventional pain relief options for chronic LBP and radiculopathy cause weight gain, capsaicin has been widely studied for its weight loss potential.
Emerging evidence suggests the use of topical capsaicin may be a safe and efficacious treatment for chronic LBP and radiculopathy. With regards to LBP, a 2010 double-blind multi-center randomized clinical trial on the use of 0.05% topical capsaicin cream for the treatment of chronic LBP demonstrated a significantly higher number of patients experiencing at least 50% pain sum score improvement at 3 weeks compared to placebo. A 2016 open-label study of 90 patients with lumbosacral neuropathic pain who received treatment with a topical 8% capsaicin patch found statistically significant reductions in pain at 2, 8, and 12 weeks follow-up. With regards to lumbosacral radiculopathy, a 2017 randomized controlled trial of 50 participants with chronic lumbosacral radiculopathy treated with a topical 8% capsaicin patch found at least a 30% improvement of pain in 71.4% and 39.1% of patients with 3 months to 2 years duration of pain and greater than 2 years duration of pain, respectively. A prospective study investigating the use of a single 8% capsaicin patch in patients with a variety of neuropathic pain conditions, including radiculopathy noted that the proportions of patients achieving a 30% and 50% decrease in pain at 12 weeks were 43% and 24%, respectively. Additionally, a small retrospective analysis of patients with painful radiculopathy found that the capsaicin 8% patch provided rapid and sustained pain relief, with a significant reduction in prescribed concomitant pain medications. In brief, the current literature is limited by small sample sizes and short follow up periods but does suggest topical capsaicin is a rational choice for the treatment of neuropathic lumbosacral pain.
The neuropathic components in chronic LBP and lumbosacral radiculopathy may be under-recognized and therefore undertreated. Most clinical trials of drug treatments for neuropathic pain have examined patients with Postherpetic neuralgia or painful diabetic peripheral neuropathy, and the extent to which results of these studies can be extrapolated to other neuropathic conditions is unknown. Use of the Qutenza (8% capsaicin) topical patch for the treatment of chronic LBP and lumbosacral radiculopathy holds great promise to improve the pain and function of patients suffering with these common and debilitating conditions, which in turn has the potential for tremendous economic impact.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with neuropathic LBP and painful lumbosacral radiculopathy | – | Drug: Qutenza® 8% Capsaicin Topical Systempatients with neuropathic LBP and painful lumbosacral radiculopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qutenza® 8% Capsaicin Topical SystemTreatment of patients with neuropathic LBP and painful lumbosacral radiculopathy using the Qutenza 8% capsaicin topical system. | Drug | Patients with neuropathic LBP and painful lumbosacral radiculopathy |
Primary outcome
Incidence of treatment emergent adverse effects as assessed by routine patient monitoring of subjects treated with Qutenza 8% capsaicin topical system for LBP and lumbosacral radiculopathy
Time frame: at 12 months
The primary aim of this pilot study is to assess whether the Qutenza 8% capsaicin topical system is an effective treatment for neuropathic lower back pain and painful lumbosacral radiculopathy as based on PROMIS-29 scores for pain and quality of life. Safety will be determined by the number of participants with treatment-related adverse events as assessed by routine clinical monitoring
3 secondary outcomes
Assess changes in body mass index (BMI) in patients receiving the Qutenza 8% capsaicin topical system.
Time frame: at 12 months
Assess changes in quality of life and sleep in patients receiving the Qutenza 8% capsaicin topical system.
Time frame: at 12 months
Assess changes in medication and procedural utilization in patients receiving the Qutenza 8% capsaicin topical system.
Time frame: at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Sherrier principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Back Pain and Lumbosacral Radiculopathy, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse effects as assessed by routine patient monitoring of subjects treated with Qutenza 8% capsaicin topical system for LBP and lumbosacral radiculopathy (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.