Spinal Cord InjuriesCapsaicinNCT02441660
Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain
A study testing Capsaicin 8% Patch and Low Dose Capsaicin 0.025% Well Patch in people with Spinal Cord Injuries and Neuropathic Pain, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
A prospective case control study to determine the effectiveness and longevity of 8% capsaicin patch(es) in treating neuropathic pain in persons with spinal cord injury. The investigators will study spinal cord injury patients at South Texas Veterans Health Care Systems Spinal Cord Injury inpatient unit and outpatient… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Neuropathic Pain
- What is being tested?
- Capsaicin 8% Patch and Low Dose Capsaicin 0.025% Well Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 2 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of SCI
- Neuropathic pain below level of injury
- Surface area of pain no larger than 2 patches
- Failed or did not tolerate gabapentin 3600mg/day, pregabalin 600mg/day, capsaicin cream and/or lidocaine cream
- Skin over painful area intact
Who cannot join
- Pain over open wound
- Previously documented allergy to capsaicin
- Superficial burn over area of pain
- Premorbid (before SCI) neuropathic pain
- HIV/AIDS neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Audie Lee Murphy VA Hospital
San Antonio, Texas, 78229
About this study
A prospective case control study to determine the effectiveness and longevity of 8% capsaicin patch(es) in treating neuropathic pain in persons with spinal cord injury. The investigators will study spinal cord injury patients at South Texas Veterans Health Care Systems Spinal Cord Injury inpatient unit and outpatient clinics.
Read the detailed description
The investigators will recruit ~ 20 patients with chronic spinal cord injury (SCI) and chronic neuropathic pain (>6months) below level of injury who have failed multiple pharmacological agents. Pre-study data collection will include subjective description of pain, baseline visual analog scale (VAS), numeric pain rating scale (NPRS), a numerical scale such as short form (SF) 36 form that measures quality of life parameters, subjective functional independence (FIM) scores, and pain diagrams will be obtained on each participant. Written informed consent will be obtained. After randomization patients will be assigned to a different sequence of treatment.
All patients will receive either the treatment and control patches in a randomized order for a total of three treatment periods (control, treatment, treatment for example). When assigned to received treatment arm of study patients will receive Qutenza Capsaicin 8% patch(es) applied for 1 hour after pre- treatment with topical lidocaine. The control group will receive a low dose (0.04%) amount of capsaicin in patch form using an identical application procedure.
Investigators will give each patient a diary to self record daily VAS/NPRS scores. Investigators will then schedule routine f/u via telephone call at 2, 4, 8, and 12 weeks post application to accurately report onset of relief and obtain NPRS scores at 2, 4, 8, 12 week points. Patients will follow up in clinic at the end of the 12 week study to repeat data collection using our quality of life scale (SF 36) and FIM scores. Investigators will then use data analysis to record percentage of reduction in NPRS/ VAS, and changes in SF 36 and FIM scores at any given time point vs baseline. For those that continue to have pain relief at 12 week mark we will periodically call every 4 months after study completion to assess for total duration of pain relief for up to 1 year post application.
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Being tested
- Capsaicin 8% Patch, Low Dose Capsaicin 0.025% Well Patch
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin 8% PatchDrug
Also called Qutenza
Applied topically for 1 hour
Low Dose Capsaicin 0.025% Well PatchDrug
Also called Control Capsacin patch
| Study group | Role | What they receive |
|---|---|---|
| Investigational Capsacin, Then Control Capsacin | Experimental | Qutenza, Capsaicin 8% Patch will be used for 12 weeks followed by capsacin 0.025% Well Patch Receives: Drug: Capsaicin 8% Patch; Drug: Low Dose Capsaicin 0.025% Well Patch |
| Control Capsacin, Then Investigational Capsacin | Experimental | Active control with low dose capsaicin 0.025% Well Patch used for 12 weeks followed by Qutenza 8% Patch Receives: Drug: Capsaicin 8% Patch; Drug: Low Dose Capsaicin 0.025% Well Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Relief With Visual Analog (VAS) Pain Scale
The Visual Analog Scale (VAS) was used as the primary outcome measure to quantify pain on a scale of 0-10, with 0 being no pain and 10 being the worst pain. VAS was measured at weeks 2,4,6,8,10 and12 during each 12- week block.
Measured: Change in pain at 2,4,6,8, 10 and 12 weeks
Change in Quality of Life as Measured by the World Health Organization Quality of Life (WHOQOL-BREF)
The World Health Organization Quality of Life (WHOQOL-BREF) questionnaire is a scale used to assess an individual's perception of their quality of life. Its domains include physical health, psychological health, social relationships, and patient environment. It is scored from 0-100, where lower scores indicate poorer perception of quality of life and higher scores indicate better perception. This scale was used to investigate if there was any pattern of change in QOL due to improved pain control. WHO-QOL-BREF was also measured every 4 weeks of each period.
Measured: Every 4 weeks for 12 weeks
Change in Spinal Cord Independence Measure (SCIM)
The Spinal Cord Independence Measure (SCIM) is a reliable scale that measures proficiency of activities of daily living (ADL's) of patients with spinal cord injuries. (28) It is broken up into four subscales including self-care, respiration and sphincter control, and mobility with a total score combining all 3 outcomes.
It is scored from 0-100, where lower numbers indicate more dependence on others and higher numbers indicate less dependence. This tool can be applied practically to the study to investigate everyday function before and after patch application. SCIM was administered every 4 weeks of each period.
Measured: Every 4 weeks for12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startApr 2016
- Primary completion31 Jul 2021
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Study participants are assigned to both strengths of the intervention, so all study participants receive both strengths, thus acting as their own control. Data will be compared according to intervention, rather than following each subject from beginning of study through both interventions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Trbovich, MD, Principal investigator, South Texas Veterans Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441660
- Sponsor's protocol ID
- HSC20150322H
- Acronym
- Capsaicin
- Status last verified
- Jan 2023
- First submitted
- 28 Apr 2015
- Last updated
- 26 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain
- ClinicalTrials.gov ID
- NCT02441660
- Acronym / sponsor ID
- Capsaicin / HSC20150322H
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Posted 6 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective case control study to determine the effectiveness and longevity of 8% capsaicin patch(es) in treating neuropathic pain in persons with spinal cord injury. The investigators will study spinal cord injury patients at South Texas Veterans Health Care Systems Spinal Cord Injury inpatient unit and outpatient clinics.
Detailed description
The investigators will recruit ~ 20 patients with chronic spinal cord injury (SCI) and chronic neuropathic pain (>6months) below level of injury who have failed multiple pharmacological agents. Pre-study data collection will include subjective description of pain, baseline visual analog scale (VAS), numeric pain rating scale (NPRS), a numerical scale such as short form (SF) 36 form that measures quality of life parameters, subjective functional independence (FIM) scores, and pain diagrams will be obtained on each participant. Written informed consent will be obtained. After randomization patients will be assigned to a different sequence of treatment.
All patients will receive either the treatment and control patches in a randomized order for a total of three treatment periods (control, treatment, treatment for example). When assigned to received treatment arm of study patients will receive Qutenza Capsaicin 8% patch(es) applied for 1 hour after pre- treatment with topical lidocaine. The control group will receive a low dose (0.04%) amount of capsaicin in patch form using an identical application procedure.
Investigators will give each patient a diary to self record daily VAS/NPRS scores. Investigators will then schedule routine f/u via telephone call at 2, 4, 8, and 12 weeks post application to accurately report onset of relief and obtain NPRS scores at 2, 4, 8, 12 week points. Patients will follow up in clinic at the end of the 12 week study to repeat data collection using our quality of life scale (SF 36) and FIM scores. Investigators will then use data analysis to record percentage of reduction in NPRS/ VAS, and changes in SF 36 and FIM scores at any given time point vs baseline. For those that continue to have pain relief at 12 week mark we will periodically call every 4 months after study completion to assess for total duration of pain relief for up to 1 year post application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Study participants are assigned to both strengths of the intervention, so all study participants receive both strengths, thus acting as their own control. Data will be compared according to intervention, rather than following each subject from beginning of study through both interventions.
| Arm | Type | Receives |
|---|---|---|
| Investigational Capsacin, Then Control Capsacin | Experimental | Drug: Capsaicin 8% Patch, Drug: Low Dose Capsaicin 0.025% Well PatchQutenza, Capsaicin 8% Patch will be used for 12 weeks followed by capsacin 0.025% Well Patch |
| Control Capsacin, Then Investigational Capsacin | Experimental | Drug: Capsaicin 8% Patch, Drug: Low Dose Capsaicin 0.025% Well PatchActive control with low dose capsaicin 0.025% Well Patch used for 12 weeks followed by Qutenza 8% Patch |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of SCI
- Neuropathic pain below level of injury
- Surface area of pain no larger than 2 patches
- Failed or did not tolerate gabapentin 3600mg/day, pregabalin 600mg/day, capsaicin cream and/or lidocaine cream
- Skin over painful area intact
Key exclusion criteria (5 listed)
- Pain over open wound
- Previously documented allergy to capsaicin
- Superficial burn over area of pain
- Premorbid (before SCI) neuropathic pain
- HIV/AIDS neuropathy
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 |
|---|---|---|
| Capsaicin 8% PatchAlso: QutenzaApplied topically for 1 hour | Drug | Control Capsacin, Then Investigational Capsacin, Investigational Capsacin, Then Control Capsacin |
| Low Dose Capsaicin 0.025% Well PatchAlso: Control Capsacin patch | Drug | Control Capsacin, Then Investigational Capsacin, Investigational Capsacin, Then Control Capsacin |
Primary outcome
Change in Pain Relief With Visual Analog (VAS) Pain Scale
Time frame: Change in pain at 2,4,6,8, 10 and 12 weeks
The Visual Analog Scale (VAS) was used as the primary outcome measure to quantify pain on a scale of 0-10, with 0 being no pain and 10 being the worst pain. VAS was measured at weeks 2,4,6,8,10 and12 during each 12- week block.
Change in Quality of Life as Measured by the World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: Every 4 weeks for 12 weeks
The World Health Organization Quality of Life (WHOQOL-BREF) questionnaire is a scale used to assess an individual's perception of their quality of life. Its domains include physical health, psychological health, social relationships, and patient environment. It is scored from 0-100, where lower scores indicate poorer perception of quality of life and higher scores indicate better perception. This scale was used to investigate if there was any pattern of change in QOL due to improved pain control. WHO-QOL-BREF was also measured every 4 weeks of each period.
Change in Spinal Cord Independence Measure (SCIM)
Time frame: Every 4 weeks for12 weeks
The Spinal Cord Independence Measure (SCIM) is a reliable scale that measures proficiency of activities of daily living (ADL's) of patients with spinal cord injuries. (28) It is broken up into four subscales including self-care, respiration and sphincter control, and mobility with a total score combining all 3 outcomes. It is scored from 0-100, where lower numbers indicate more dependence on others and higher numbers indicate less dependence. This tool can be applied practically to the study to investigate everyday function before and after patch application. SCIM was administered every 4 weeks of each period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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. This study is not recruiting at the moment.
Michelle Trbovich, MD principal investigator
South Texas Veterans Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsaicin 8% Patch and Low Dose Capsaicin 0.025% Well Patch in people with Spinal Cord Injuries and Neuropathic Pain, run by The University of Texas Health Science Center at San Antonio 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 5 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: finished, as of the sponsor's last update on 26 Jan 2023. 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?
Yes. Results are posted in the registry (first posted 6 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Pain Relief With Visual Analog (VAS) Pain Scale (time frame: Change in pain at 2,4,6,8, 10 and 12 weeks). The study lists 3 primary outcomes in all. 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 26 Jan 2023.