NCT02441660: Capsaicin

Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain

Completed NA Results posted Last updated 23 January 2023

What this trial tests

NA trial testing Capsaicin 8% Patch in Spinal Cord Injuries in 11 participants. Completed in 2 May 2022.

Timeline

1 April 2016

Primary endpoint
31 July 2021

2 May 2022

Quick facts

Lead sponsor	The University of Texas Health Science Center at San Antonio
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	11
Start date	1 April 2016
Primary completion	31 July 2021
Estimated completion	2 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Capsaicin 8% Patch
• Low Dose Capsaicin 0.025% Well Patch — full drug profile →

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
• Neuropathic Pain — all drugs for Neuropathic Pain →

Sponsor

The University of Texas Health Science Center at San Antonio

Who can join

Adults 18 to 99, any sex, with Spinal Cord Injuries or Neuropathic Pain. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
• 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 othe

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Review of the Treatments for Central Neuropathic Pain.
   Sheldon BL, Olmsted ZT, Sabourin S, Heydari E, et al · · 2022 · cited 12× · PMID 36552186 · DOI 10.3390/brainsci12121727
2. Transient Receptor Potential Channels as Key Regulators of Neuroinflammation in Neurological Disorders: Mechanistic Insights, Therapeutic Potentials, and Future Directions.
   Guo D, Cai M, Xian Y, Chen Y, et al · · 2025 · cited 1× · PMID 41399206 · DOI 10.1002/cns.70700