Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-25 @ 1:53 PM
Study NCT ID:
NCT03464292
Status:
COMPLETED
Last Update Posted:
2023-12-14
First Post:
2018-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| OCR17639 | OTHER | University of Florida | View |