Back to resultsSpinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia
Primary Purpose
Fibromyalgia, Pain
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Capsaicin Patch 8% or 0.1% Capsaicin Cream
Vehicle Patch
Sponsored by
About this trial
This is an interventional basic science trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria:
- individuals diagnosed with fibromyalgia will have pain of duration > 6 months and meeting the 1990 Research Diagnostic Criteria for FM (ACR).
- healthy, pain-free age matched controls without chronic pain
Exclusion Criteria:
- Allergy to red chili peppers;
- Pregnant;
- Significant hearing loss;
- Presence of chronic disease (e.g. cancer, cardiovascular disease, liver disease, kidney disease, diabetes, etc.).
- FM patients must be willing to discontinue or hold their FM related medications for at least 5 half-lives.
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Vehicle Patch
Capsaicin Patch 8% or 0.1% Capsaicin Cream
Arm Description
Control patch will be the same topical solution but will not contain capsaicin. The patch will applied to the hand for 30 - 60 min. Patients will be instructed to not touch or wash their hands during the course of the study to minimize spreading of the patch to other areas of the body. Subsequently, the patch will be immediately removed.
8% capsaicin topical patch or 0.1% capsaicin cream. The patch will applied to the hand for 30 - 60 min. The cream will be applied similarly on a 3 cm2 area of the arm. Patients will be instructed to not touch or wash their hands during the course of the study to minimize spreading of the patch to other areas of the body. Subsequently, the patch will be immediately removed.
Outcomes
Primary Outcome Measures
Progression of Temporal Summation of Second Pain
A Peltier device (Pathway, Medoc) will be used to tap the skin surface with a 3 cm x 3 cm probe. The Peltier device will be used to provide very brief, repetitive, thermal stimuli (for approx. 1s) to the skin using computer controlled temperatures. Heat stimuli at intervals of 2.5 sec produce sensations of increasing pain (temporal summation), depending on the number of stimuli presented. The late sensations of warmth are delayed in onset by approximately 1.5 sec after the probe touches the skin, because the sensation depends upon stimulation of slowly conducting unmyelinated peripheral afferents.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03464292
Brief Title
Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia
Official Title
Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 5, 2018 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fibromyalgia (FM) patients have increased windup (WU). However, WU of FM patients is only quantitatively but not qualitatively different from healthy controls (HC). Thus WU abnormalities of FM patients could be the result of supra-spinal and not the result of spinal pain mechanisms. The study team will test this hypothesis by sensitizing FM patients with topical capsaicin.
Detailed Description
The study team hypothesizes that at baseline the slopes of sensitivity adjusted WU of FM patients are not statistically different from HC. However, after capsaicin application, the slopes of sensitivity adjusted WU will be significantly different from baseline and greater than those of HC, suggesting central sensitization. This would imply that FM patients are sensitive to heat pain but not sensitized.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This parallel study will be age & sex matched, randomized and placebo controlled . Only the outcome assessor but not the subjects will be blinded to the study intervention
Masking
Outcomes Assessor
Masking Description
Identically looking placebo will be used. The outcome assessor will not be aware which study drug was applied to the subjects
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vehicle Patch
Arm Type
Placebo Comparator
Arm Description
Control patch will be the same topical solution but will not contain capsaicin. The patch will applied to the hand for 30 - 60 min. Patients will be instructed to not touch or wash their hands during the course of the study to minimize spreading of the patch to other areas of the body. Subsequently, the patch will be immediately removed.
Arm Title
Capsaicin Patch 8% or 0.1% Capsaicin Cream
Arm Type
Active Comparator
Arm Description
8% capsaicin topical patch or 0.1% capsaicin cream. The patch will applied to the hand for 30 - 60 min. The cream will be applied similarly on a 3 cm2 area of the arm. Patients will be instructed to not touch or wash their hands during the course of the study to minimize spreading of the patch to other areas of the body. Subsequently, the patch will be immediately removed.
Intervention Type
Drug
Intervention Name(s)
Capsaicin Patch 8% or 0.1% Capsaicin Cream
Other Intervention Name(s)
Qutenza, Capsaicin No-Fuss
Intervention Description
0.1 ml of 8% capsaicin topical patch or 0.1% capsaicin cream
Intervention Type
Other
Intervention Name(s)
Vehicle Patch
Intervention Description
Control patch will be the same topical solution but will not contain capsaicin.
Primary Outcome Measure Information:
Title
Progression of Temporal Summation of Second Pain
Description
A Peltier device (Pathway, Medoc) will be used to tap the skin surface with a 3 cm x 3 cm probe. The Peltier device will be used to provide very brief, repetitive, thermal stimuli (for approx. 1s) to the skin using computer controlled temperatures. Heat stimuli at intervals of 2.5 sec produce sensations of increasing pain (temporal summation), depending on the number of stimuli presented. The late sensations of warmth are delayed in onset by approximately 1.5 sec after the probe touches the skin, because the sensation depends upon stimulation of slowly conducting unmyelinated peripheral afferents.
Time Frame
2 hr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
individuals diagnosed with fibromyalgia will have pain of duration > 6 months and meeting the 1990 Research Diagnostic Criteria for FM (ACR).
healthy, pain-free age matched controls without chronic pain
Exclusion Criteria:
Allergy to red chili peppers;
Pregnant;
Significant hearing loss;
Presence of chronic disease (e.g. cancer, cardiovascular disease, liver disease, kidney disease, diabetes, etc.).
FM patients must be willing to discontinue or hold their FM related medications for at least 5 half-lives.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Staud, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia
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