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Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome

Not Applicable
Recruiting
Conditions
Fibromyalgia
Interventions
Behavioral: Paced Auditory Serial Addition task (PASAT)
Registration Number
NCT04415866
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Effects of PASAT on Sensory TestingPaced Auditory Serial Addition task (PASAT)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.
Primary Outcome Measures
NameTimeMethod
Visual Evoked Potentials (VEP) During Flicker1 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.

Verbal Pain Ratings of Painful Heat and Pressure Stimuli using a Numerical Pain Scale from 0 - 1001 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.

Secondary Outcome Measures
NameTimeMethod
Response to 2011 Fibromyalgia Criteria Questionnaire0.5 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 Questionnaire0.5 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.

Trial Locations

Locations (1)

University of Florida

🇺🇸

Gainesville, Florida, United States

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