Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome

Sponsor

University of Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT04415866

Collaborator

(none)

100

Enrollment

Location

Arm

58.1

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 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.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 :

Aug 28, 2020

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Verbal Pain Ratings of Painful Heat and Pressure Stimuli using a Numerical Pain Scale from 0 - 100 [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 [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

Response to 2011 Fibromyalgia Criteria Questionnaire [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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