N/A
N=11
Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain
Spinal Cord Injuries · Neuropathic Pain
Bottom Line
View on ClinicalTrials.gov: NCT02441660 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Change in Pain Relief With Visual Analog (VAS) Pain Scale — 3.586; 5.494; 4.041; 5.677 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Capsaicin 8% Patch (Drug); Low Dose Capsaicin 0.025% Well Patch (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Relief With Visual Analog (VAS) Pain Scale |
3.586; 5.494; 4.041; 5.677; 4.984; 5.768 | — |
| PRIMARY Change in Quality of Life as Measured by the World Health Organization Quality of Life (WHOQOL-BREF) |
79.26; 80.91; 80.91; 85.42; 74.90; 87.42 | — |
| PRIMARY Change in Spinal Cord Independence Measure (SCIM) |
20.32; 18.86; 20.70; 18.66; 19.23; 18.86 | — |
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 clinics.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Pain over open wound
- Previously documented allergy to capsaicin
- Superficial burn over area of pain
- Premorbid (before SCI) neuropathic pain
- HIV/AIDS neuropathy
Data sourced from ClinicalTrials.gov (NCT02441660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.