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Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome

Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04415866
Enrollment
30
Registered
2020-06-04
Start date
2020-08-28
Completion date
2020-12-11
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

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

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.

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.

Interventions

BEHAVIORALPaced 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.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Verbal Pain Ratings of Painful Heat and Pressure Stimuli using a Numerical Pain Scale from 0 - 1001 hourFM 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 Flicker1 hourFM 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

MeasureTime frameDescription
Response to 2011 Fibromyalgia Criteria Questionnaire0.5 hoursFM 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 Questionnaire0.5 hoursFM 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026