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Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia

NCT ID: NCT03464292

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-05

Study Completion Date

2023-12-08

Brief Summary

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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

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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.

Conditions

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Fibromyalgia Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Vehicle Patch

Intervention Type OTHER

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

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.

Capsaicin Patch 8% or 0.1% Capsaicin Cream

Intervention Type DRUG

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

Interventions

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Capsaicin Patch 8% or 0.1% Capsaicin Cream

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

Intervention Type DRUG

Vehicle Patch

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

Intervention Type OTHER

Other Intervention Names

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Qutenza Capsaicin No-Fuss

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roland Staud, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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OCR17639

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201800479

Identifier Type: -

Identifier Source: org_study_id