Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome

NCT04415866 | Completed

• 1 other identifier: IRB202000992
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

central sensitization; peripheral sensitization; visual evoke potentials (VEP); quantitative sensory testing

Outcome Measures

Primary Outcomes (2)

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

  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.

  1 hour

• Visual Evoked Potentials (VEP) During Flicker

  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.

  1 hour

Secondary Outcomes (2)

• Response to 2011 Fibromyalgia Criteria Questionnaire

  0.5 hours

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

  0.5 hours

Study Arms (1)

Effects of PASAT on Sensory Testing

EXPERIMENTAL

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)

Interventions

Paced Auditory Serial Addition task (PASAT) 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.

Effects of PASAT on Sensory Testing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (4)

• Geisser ME, Strader Donnell C, Petzke F, Gracely RH, Clauw DJ, Williams DA. Comorbid somatic symptoms and functional status in patients with fibromyalgia and chronic fatigue syndrome: sensory amplification as a common mechanism. Psychosomatics. 2008 May-Jun;49(3):235-42. doi: 10.1176/appi.psy.49.3.235.

  PMID: 18448779 BACKGROUND

• Geisser ME, Glass JM, Rajcevska LD, Clauw DJ, Williams DA, Kileny PR, Gracely RH. A psychophysical study of auditory and pressure sensitivity in patients with fibromyalgia and healthy controls. J Pain. 2008 May;9(5):417-22. doi: 10.1016/j.jpain.2007.12.006. Epub 2008 Feb 15.

  PMID: 18280211 BACKGROUND

• Frank MG, Fonken LK, Watkins LR, Maier SF. Microglia: Neuroimmune-sensors of stress. Semin Cell Dev Biol. 2019 Oct;94:176-185. doi: 10.1016/j.semcdb.2019.01.001. Epub 2019 Jan 9.

  PMID: 30638704 BACKGROUND

• Geisser ME, Casey KL, Brucksch CB, Ribbens CM, Appleton BB, Crofford LJ. Perception of noxious and innocuous heat stimulation among healthy women and women with fibromyalgia: association with mood, somatic focus, and catastrophizing. Pain. 2003 Apr;102(3):243-250. doi: 10.1016/S0304-3959(02)00417-7.

  PMID: 12670665 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Roland Staud, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 4, 2020
• Study Start: August 28, 2020
• Primary Completion: December 11, 2020
• Study Completion: December 11, 2020
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)