Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03464292|
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : March 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia Pain||Drug: Capsaicin Patch 8% or 0.1% Capsaicin Cream Other: Vehicle Patch||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|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 2020|
|Estimated Study Completion Date :||May 2020|
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% 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
0.1 ml of 8% capsaicin topical patch or 0.1% capsaicin cream
- 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.
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
|Contact: Melyssa Godfreyemail@example.com|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Roland Staud, MD||University of Florida|