Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome

University of Florida

Status: Enrolling

Conditions: Fibromyalgia

Treatments: Behavioral: Paced Auditory Serial Addition task (PASAT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04415866

IRB202000992

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Effects of PASAT on Sensory Testing

Experimental group

Description:

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.

Treatment:

Behavioral: Paced Auditory Serial Addition task (PASAT)