Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain

The University of Texas System (UT)

Status: Completed

Conditions: Spinal Cord Injuries; Neuropathic Pain

Treatments: Drug: Capsaicin 8% Patch; Drug: Low Dose Capsaicin 0.025% Well Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT02441660

HSC20150322H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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11 participants in 2 patient groups

Investigational Capsacin, Then Control Capsacin

Experimental group

Description:

Qutenza, Capsaicin 8% Patch will be used for 12 weeks followed by capsacin 0.025% Well Patch

Treatment:

Drug: Low Dose Capsaicin 0.025% Well Patch

Drug: Capsaicin 8% Patch

Control Capsacin, Then Investigational Capsacin

Experimental group

Description:

Active control with low dose capsaicin 0.025% Well Patch used for 12 weeks followed by Qutenza 8% Patch

Treatment:

Drug: Low Dose Capsaicin 0.025% Well Patch

Drug: Capsaicin 8% Patch