Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain (Capsaicin)
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|ClinicalTrials.gov Identifier: NCT02441660|
Recruitment Status : Recruiting
First Posted : May 12, 2015
Last Update Posted : August 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries Neuropathic Pain||Drug: Capsaicin 8% Patch Drug: Low Dose Capsaicin 0.04% gel||Not Applicable|
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 randomization patients will be assigned to a different sequence of treatment.
All patients will receive either the treatment and control patches in a randomized order for a total of three treatment periods (control, treatment, treatment for example). When assigned to received treatment arm of study patients will receive Qutenza Capsaicin 8% patch(es) applied for 1 hour after pre- treatment with topical lidocaine. The control group will receive a low dose (0.04%) amount of capsaicin in patch form 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||July 30, 2020|
|Estimated Study Completion Date :||December 2021|
Experimental: experimental group
Qutenza, Capsaicin 8% Patch will be used
Drug: Capsaicin 8% Patch
Applied topically for 1 hour
Other Name: Qutenza
Active Comparator: control group
Active control with low dose capsaicin
Drug: Low Dose Capsaicin 0.04% gel
- Change in pain relief with Numeric Pain Rating Scale (NPRS) [ Time Frame: Change from baseline pain at 12 weeks ]
- Change in pain relief with Visual Analog (VAS) pain Scale [ Time Frame: Change from baseline pain at 12 weeks ]
- Change in Quality of life as measured by Short Form (Sf) 36 quality of life score [ Time Frame: Change from baseline at 12 weeks ]he SF-36 is a measure of health status and an abbreviated variant of it, the SF-6D, is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment.
- Change in Functional Independence as measured by Functional Independence Measure (FIM) scores [ Time Frame: Change from baseline at 12 weeks ]Measure of change in functional independence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02441660
|Contact: Christina Nguyen, MD||832-274-3292||NguyenC4@UTHSCSA.edu|
|Contact: Michelle Trbovich, MDemail@example.com|
|United States, Texas|
|Audie Lee Murphy VA Hospital||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Michelle Trbovich, MD 210-392-2340|
|Principal Investigator:||Michelle Trbovich, MD||South Texas Veterans Health Care System|