Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain

NCT ID: NCT02441660

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2022-05-02

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.

Conditions

Spinal Cord Injuries; Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Investigational Capsacin, Then Control Capsacin

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

Group Type: EXPERIMENTAL

Capsaicin 8% Patch

Intervention Type: DRUG

Applied topically for 1 hour

Low Dose Capsaicin 0.025% Well Patch

Intervention Type: DRUG

Control Capsacin, Then Investigational Capsacin

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

Group Type: EXPERIMENTAL

Capsaicin 8% Patch

Intervention Type: DRUG

Applied topically for 1 hour

Low Dose Capsaicin 0.025% Well Patch

Intervention Type: DRUG

Interventions

Capsaicin 8% Patch

Applied topically for 1 hour

Intervention Type: DRUG

Low Dose Capsaicin 0.025% Well Patch

Intervention Type: DRUG

Other Intervention Names

Qutenza; Control Capsacin patch

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Trbovich, MD

Role: PRINCIPAL_INVESTIGATOR

South Texas Veterans Health Care System

Locations

Audie Lee Murphy VA Hospital

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC20150322H

Identifier Type: -

Identifier Source: org_study_id