Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia

Pain Clinical Trial

Official title:

Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464292
• Other study ID #: IRB201800479
• Secondary ID: OCR17639
• Status: Completed
• Start date: July 5, 2018
• Est. completion date: December 8, 2023

Study information

• Verified date: May 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 8, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Pain

Intervention

Drug:
• Capsaicin Patch 8% or 0.1% Capsaicin Cream
0.1 ml of 8% capsaicin topical patch or 0.1% capsaicin cream

Other:
• Vehicle Patch
Control patch will be the same topical solution but will not contain capsaicin.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 hr