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Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain (Capsaicin)

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ClinicalTrials.gov Identifier: NCT02441660
Recruitment Status : Recruiting
First Posted : May 12, 2015
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Neuropathic Pain Drug: Capsaicin 8% Patch Drug: Low Dose Capsaicin 0.04% gel Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain
Study Start Date : April 2016
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arms and Interventions
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Arm Intervention/treatment
Experimental: experimental group
Qutenza, Capsaicin 8% Patch will be used
 Drug: Capsaicin 8% Patch
Applied topically for 1 hour
Other Name: Qutenza
Active Comparator: control group
Active control with low dose capsaicin
 Drug: Low Dose Capsaicin 0.04% gel


Outcome Measures
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Primary Outcome Measures :
  1. Change in pain relief with Numeric Pain Rating Scale (NPRS) [ Time Frame: Change from baseline pain at 12 weeks ]
  2. Change in pain relief with Visual Analog (VAS) pain Scale [ Time Frame: Change from baseline pain at 12 weeks ]
  3. Change in Quality of life as measured by Short Form (Sf) 36 quality of life score [ Time Frame: Change from baseline at 12 weeks ]
    he SF-36 is a measure of health status and an abbreviated variant of it, the SF-6D, is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment.

  4. Change in Functional Independence as measured by Functional Independence Measure (FIM) scores [ Time Frame: Change from baseline at 12 weeks ]
    Measure of change in functional independence


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02441660


Contacts
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Contact: Christina Nguyen, MD 832-274-3292 NguyenC4@UTHSCSA.edu
Contact: Michelle Trbovich, MD 210-818-4353 mbrand.md@gmail.com

Locations
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United States, Texas
Audie Lee Murphy VA Hospital Recruiting
San Antonio, Texas, United States, 78229
Contact: Michelle Trbovich, MD    210-392-2340      
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Michelle Trbovich, MD South Texas Veterans Health Care System
More Information
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02441660     History of Changes
Other Study ID Numbers: HSC20150322H
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2018
Additional relevant MeSH terms:
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Spinal Cord Injuries
Neuralgia
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Pain
Neurologic Manifestations
Signs and Symptoms
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs