← Back to Search

Behavioral Intervention

PASAT for Fibromyalgia

N/A

Recruiting

Led By Roland Staud, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy, pain-free age and sex matched controls without chronic pain

Individuals diagnosed with FM will have pain of > 3 months and meet the 1990 and 2011 Diagnostic Criteria for FM (ACR)

Must not have

Family history of photosensitive epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0.5 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to see if a treatment to stop the central sensitization will lessen the pain of FM.

Who is the study for?

This trial is for individuals diagnosed with Fibromyalgia (FM) who have experienced pain for more than 3 months and meet specific diagnostic criteria. Healthy people without chronic pain can also join as controls. Participants should not have chronic diseases or significant vision loss, and FM patients must pause their medications for at least a day before the visit.

What is being tested?

The study is testing how people with FM respond to a Paced Auditory Serial Addition Task (PASAT), which may help understand central hypersensitivity—a key mechanism in FM that relates to abnormal pain perception.

What are the potential side effects?

Since PASAT is a non-invasive cognitive task involving listening and adding numbers, it does not have typical drug side effects. However, participants might experience mental fatigue or stress during the task.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am healthy, without chronic pain, and match the age and sex criteria.

Select...

I have been diagnosed with fibromyalgia and have had pain for more than 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My family has a history of epilepsy triggered by lights.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0.5 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0.5 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0.5 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Visual Evoked Potentials (VEP) During Flicker

Secondary study objectives

Response to 2011 Fibromyalgia Criteria Questionnaire

Response to the Center for Epidemiological Studies (CES-D) Depression Questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Effects of PASAT on Sensory TestingExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met