Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain

NCT02441660 | Completed Results

• 1 other identifier: HSC20150322H
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries; Neuropathic Pain

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Every 4 weeks for12 weeks

Study Arms (2)

Investigational Capsacin, Then Control Capsacin

EXPERIMENTAL

Qutenza, Capsaicin 8% Patch will be used for 12 weeks followed by capsacin 0.025% Well Patch

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

Drug: Capsaicin 8% Patch; Drug: Low Dose Capsaicin 0.025% Well Patch

Interventions

Capsaicin 8% Patch DRUG

Applied topically for 1 hour

Also known as: Qutenza

Control Capsacin, Then Investigational Capsacin; Investigational Capsacin, Then Control Capsacin

Low Dose Capsaicin 0.025% Well Patch DRUG

Also known as: Control Capsacin patch

Control Capsacin, Then Investigational Capsacin; Investigational Capsacin, Then Control Capsacin

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pain over open wound
• Previously documented allergy to capsaicin
• Superficial burn over area of pain
• Premorbid (before SCI) neuropathic pain
• HIV/AIDS neuropathy

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Audie Lee Murphy VA Hospital

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia

Interventions

Capsaicin; Transdermal Patch

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Equipment and Supplies

Results Point of Contact

• Title: Michelle Trbovich
• Organization: UT Health San Antonio

TrbovichM@uthscsa.edu

210-617-5300

Study Officials

• Michelle Trbovich, MD

  South Texas Veterans Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 12, 2015
• Study Start: April 1, 2016
• Primary Completion: July 31, 2021
• Study Completion: May 2, 2022
• Last Updated: January 26, 2023
• Results First Posted: October 6, 2022

Record last verified: 2023-01

Locations

US (1)