Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-28

Study Completion Date

2020-12-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants sensitivity to pressure, heat, and light will be modulated by an attention task.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Paced Auditory Serial Addition task (PASAT)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes