Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain
Information source: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spinal Cord Injuries; Neuropathic Pain
Intervention: Capsaicin 8% Patch (Drug); Low Dose Capsaicin 0.04% gel (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: The University of Texas Health Science Center at San Antonio Overall contact:
Gabrielle Nguyen, MD, Phone: 405-517-4232, Email: NguyenG3@UTHSCSA.edu
Summary
A prospective study to determine the effectiveness and longevity of 8% capsaicin patch 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.
Clinical Details
Official title: Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in pain relief with Numeric Pain Rating Scale (NPRS)Change in pain relief with Visual Analog (VAS) pain Scale Change in Quality of life as measured by Short Form (Sf) 36 quality of life score Change in Functional Independence as measured by Functional Independence Measure (FIM) scores
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 3: 1 randomization (treatment:
control) patients assigned to the treatment arm of study will receive Qutenza Capsaicin 8%
patch after pre- treatment with topical lidocaine. The control group will receive a low dose
(0. 04%) capsaicin patch 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
1. Diagnosis of SCI
2. Neuropathic pain below level of injury
3. Surface area of pain no larger than 4 patches
4. Failed or did not tolerate gabapentin 3600mg/day, pregabalin 600mg/day, capsaicin
cream and/or lidocaine cream
5. Skin over painful area intact
Exclusion Criteria:
1. Pain over open wound
2. Previously documented allergy to capsaicin
3. Superficial burn over area of pain
4. Premorbid (before SCI) neuropathic pain
5. HIV/AIDS neuropathy
Locations and Contacts
Gabrielle Nguyen, MD, Phone: 405-517-4232, Email: NguyenG3@UTHSCSA.edu Additional Information
Starting date: May 2015
Last updated: May 7, 2015
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