Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain
Condition: Spinal Cord Injuries; Neuropathic Pain
MeSH terms: Spinal Cord Injuries; Neuralgia; Wounds and Injuries
Study type: Interventional

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.
    

Intervention name(s): Capsaicin 8% Patch; Low Dose Capsaicin 0.025% Well Patch
Intervention type(s): Drug; Drug
Intervention description(s): Applied topically for 1 hour
Other intervention name(s): Qutenza; Control Capsacin patch
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Crossover Assignment
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.
Masking: Single (Participant)
Primary purpose: Treatment