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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

Page last updated: August 20, 2015

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