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Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT03464292
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

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. The study team hypothesize 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Pain Drug: Capsaicin Patch 8% Other: Vehicle Patch Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This parallel study will be age & sex matched, randomized and placebo controlled . Only the outcome assessor but not the subjects will be blinded to the study intervention
Masking: Single (Outcomes Assessor)
Masking Description: Identically looking placebo will be used. The outcome assessor will not be aware which study drug was applied to the subjects
Primary Purpose: Basic Science
Official Title: Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Capsaicin

Arm Intervention/treatment
Placebo Comparator: 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
Control patch will be the same topical solution but will not contain capsaicin.

Active Comparator: Capsaicin Patch 8%
8% Capsaicin topical patch. 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.
Drug: Capsaicin Patch 8%
0.1 ml of 8% capsaicin topical patch




Primary Outcome Measures :
  1. Progression of Temporal Summation of Second Pain [ Time Frame: 2 hr ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464292


Contacts
Contact: Melyssa Godfrey 352-265-8901 painresearch@medicine.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Roland Staud, MD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03464292     History of Changes
Other Study ID Numbers: IRB201800479
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs