Clinical trial NCT02441660: Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain
Official title: Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Neuropathic Pain
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of SCI
2. Neuropathic pain below level of injury
3. Surface area of pain no larger than 2 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

Primary outcomes:
measure: Change in Pain Relief With Visual Analog (VAS) Pain Scale
timeFrame: Change in pain at 2,4,6,8, 10 and 12 weeks
measure: Change in Quality of Life as Measured by the World Health Organization Quality of Life (WHOQOL-BREF)
timeFrame: Every 4 weeks for 12 weeks
measure: Change in Spinal Cord Independence Measure (SCIM)
timeFrame: Every 4 weeks for12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Audie Lee Murphy VA Hospital
state: Texas
Study officials:
affiliation: South Texas Veterans Health Care System
name: Michelle Trbovich, MD
role: PRINCIPAL_INVESTIGATOR
References: