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NCT03464292 · ClinicalTrials.gov registry record
Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia
A clinical trial, sponsored by University of Florida.
- Completed
- Registry status
- 55
- Enrollment target
NCT03464292: Completed study, sponsored by University of Florida.
NCT03464292 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 55 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03464292 has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- 55 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Capsaicin Patch 8% or 0.1% Capsaicin Cream
- OTHER Vehicle Patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2018-07-05 |
| Est. Completion | 2023-12-08 |
What the finished NCT03464292 record still lists
NCT03464292 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 55 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Capsaicin Patch 8% or 0.1% Capsaicin Cream is the first listed.
NCT03464292 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03464292 about?
NCT03464292 is a clinical study titled "Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia". 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 w...
What is the current status of trial NCT03464292?
This trial is currently completed. The enrollment target is 55 participants. The study started on 2018-07-05. Estimated completion is 2023-12-08.
What interventions are being tested in trial NCT03464292?
The interventions under investigation include: Capsaicin Patch 8% or 0.1% Capsaicin Cream (DRUG), Vehicle Patch (OTHER).
Who is sponsoring clinical trial NCT03464292?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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