Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome
|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: NCT04415866|
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : November 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Behavioral: Paced Auditory Serial Addition task (PASAT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Participants sensitivity to pressure, heat, and light will be modulated by an attention task.|
|Masking:||None (Open Label)|
|Official Title:||Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome|
|Actual Study Start Date :||August 28, 2020|
|Estimated Primary Completion Date :||July 1, 2025|
|Estimated Study Completion Date :||July 1, 2025|
Experimental: Effects of PASAT on Sensory Testing
After baseline evaluation of light and pain sensitivity FM subjects and controls will undergo the PASAT task. This task consists of responding to a rapid presentation of numbers by ear phones. Subjects are asked to add each 2 consecutive numbers and provide a response each time the sum is equal to 13. This test will last several minutes and delivered at increasing speed.
Behavioral: Paced Auditory Serial Addition task (PASAT)
Single and double digits are presented at intervals between 2 and 3 seconds and the participant must add each new digit to the one immediately prior to it. The participants will be asked to indicate by electronic button press whether the sum of the addition is 13 or not. The duration of the PASAT will be two 12-min tasks.
- Verbal Pain Ratings of Painful Heat and Pressure Stimuli using a Numerical Pain Scale from 0 - 100 [ Time Frame: 1 hour ]FM and control subjects will provide verbal ratings of experimental pain stimuli. For this purpose a numerical ratings scale (0-100) will be used ranging from "no sensation" to the "most intense sensation possible". All measures will be obtained in triplicates and the averages will be used for statistical comparisons.
- Visual Evoked Potentials (VEP) During Flicker [ Time Frame: 1 hour ]FM and control subject will focus on a light source while VEPs are obtained. EEG tracings will be evaluated by special software to detect VEP. For intensity ratings of the flicker stimulus a numerical ratings scale (0-100) will be used ranging from "no sensation" to the "most intense sensation possible". All measures will be obtained in triplicates and the averages will be used for statistical comparisons.
- Response to 2011 Fibromyalgia Criteria Questionnaire [ Time Frame: 0.5 hours ]FM and control subjects will complete the 2011 FM Questionnaire. The answers of this questionnaire will be added to obtain the wide-spread pain index and the somatic symptom score. The scores will be combined to obtain the final score. Scores of >12 fulfill the Criteria for Fibromyalgia
- Response to the Center for Epidemiological Studies (CES-D) Depression Questionnaire [ Time Frame: 0.5 hours ]FM and control subjects will complete the CES-D. The answers of this questionnaire will be combined to obtain a final score. Total scores of >15 are consistent with the diagnosis of major depression.
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): NCT04415866
|Contact: Melyssa Godfrey, BSemail@example.com|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32610|
|Contact: Melyssa Godfrey 352-265-8901 Melyssa.Godfrey@medicine.ufl.edu|
|Principal Investigator: Roland Staud, MD|
|Principal Investigator:||Roland Staud, MD||University of Florida|