Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia

NCT03464292 | Completed

• 2 other identifiers: IRB201800479OCR17639
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vehicle Patch

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.

Other: Vehicle Patch

Capsaicin Patch 8% or 0.1% Capsaicin Cream

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.

Drug: Capsaicin Patch 8% or 0.1% Capsaicin Cream

Interventions

Capsaicin Patch 8% or 0.1% Capsaicin Cream DRUG

0.1 ml of 8% capsaicin topical patch or 0.1% capsaicin cream

Also known as: Qutenza, Capsaicin No-Fuss

Capsaicin Patch 8% or 0.1% Capsaicin Cream

Vehicle Patch OTHER

Control patch will be the same topical solution but will not contain capsaicin.

Vehicle Patch

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents living in or near Gainesville, FL

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Roland Staud, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 14, 2018
• Study Start: July 5, 2018
• Primary Completion: July 1, 2023
• Study Completion: December 8, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)