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Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome

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ClinicalTrials.gov Identifier: NCT04415866
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Fibromyalgia (FM) is a chronic musculoskeletal pain disorder with unknown causes. Our previous studies showed abnormal sensations of second pain (wind-up), indicating central hypersensitivity as an important mechanism of FM. Triggering events have been implicated as the cause of central hypersensitivity.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Paced Auditory Serial Addition task (PASAT) Not Applicable

Detailed Description:
Increasing evidence has shown that the hypersensitivity of FM is not limited to painful stimuli but seems to extend to non-painful stimuli as well. These stimuli include smell, taste, touch, light, and sound. This study will provide detailed QST examinations of FM subjects and controls' responses to light using visually evoked potentials (VEP). In addition, careful characterization of experimental pain responding across multiple sensory modalities will be examined.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
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)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Fibromyalgia

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals diagnosed with FM will have pain of > 3 months and meet the 1990 and 2011 Diagnostic Criteria for FM (ACR)
  • Healthy, pain-free age and sex matched controls without chronic pain

Exclusion Criteria:

  • 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 a minimum of one day prior to the visit.
  • Significant vision loss not corrected by eye wear
  • Family history of photosensitive epilepsy

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): NCT04415866


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

Locations
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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         
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Roland Staud, MD University of Florida
Publications:
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04415866    
Other Study ID Numbers: IRB202000992
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
central sensitization
peripheral sensitization
visual evoke potentials (VEP)
quantitative sensory testing
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Hypersensitivity
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Immune System Diseases