Clinical trial NCT04415866: Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome
Official title: Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: central sensitization
peripheral sensitization
visual evoke potentials (VEP)
quantitative sensory testing
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants sensitivity to pressure, heat, and light will be modulated by an attention task.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Verbal Pain Ratings of Painful Heat and Pressure Stimuli using a Numerical Pain Scale from 0 - 100
timeFrame: 1 hour
measure: Visual Evoked Potentials (VEP) During Flicker
timeFrame: 1 hour
Secondary outcomes:
measure: Response to 2011 Fibromyalgia Criteria Questionnaire
timeFrame: 0.5 hours
measure: Response to the Center for Epidemiological Studies (CES-D) Depression Questionnaire
timeFrame: 0.5 hours
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Roland Staud, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.