Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Hospital, Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 8/16/2018 |
| Start Date: | April 2016 |
| End Date: | December 2019 |
| Contact: | Christina Nguyen, MD |
| Email: | NguyenC4@UTHSCSA.edu |
| Phone: | 832-274-3292 |
A prospective case control 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.
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.
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 applied
for 1 hour after pre- treatment with topical lidocaine. The control group will receive a low
dose (0.04%) amount of capsaicin in a 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.
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 applied
for 1 hour after pre- treatment with topical lidocaine. The control group will receive a low
dose (0.04%) amount of capsaicin in a 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.
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
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