Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia

N/A

Waitlist Available

Led By Roland Staud, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hr

Awards & highlights

No Placebo-Only Group

Summary

This trial involves applying a cream with capsaicin, a substance from chili peppers, to the skin of fibromyalgia patients. The goal is to see if their increased pain sensitivity is due to changes in their brain and spinal cord. Researchers will compare their pain response over time to understand if central mechanisms are responsible for their pain. Capsaicin has been used for various pain conditions.

Eligible Conditions

Musculoskeletal Disease
Fibromyalgia
Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hr

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 hr

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hr for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression of Temporal Summation of Second Pain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Vehicle PatchExperimental Treatment1 Intervention

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.

Group II: Capsaicin Patch 8% or 0.1% Capsaicin CreamExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capsaicin Patch 8% or 0.1% Capsaicin Cream

2018

N/A

~60

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