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Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Paced Auditory Serial Addition task (PASAT)
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fibromyalgia focused on measuring central sensitization, peripheral sensitization, visual evoke potentials (VEP), quantitative sensory testing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Effects of PASAT on Sensory Testing

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Response to 2011 Fibromyalgia Criteria Questionnaire
FM 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 Questionnaire
FM 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.

Full Information

First Posted
May 19, 2020
Last Updated
February 17, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT04415866
Brief Title
Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome
Official Title
Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
central sensitization, peripheral sensitization, visual evoke potentials (VEP), quantitative sensory testing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants sensitivity to pressure, heat, and light will be modulated by an attention task.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Effects of PASAT on Sensory Testing
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Paced Auditory Serial Addition task (PASAT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Verbal Pain Ratings of Painful Heat and Pressure Stimuli using a Numerical Pain Scale from 0 - 100
Description
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.
Time Frame
1 hour
Title
Visual Evoked Potentials (VEP) During Flicker
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Response to 2011 Fibromyalgia Criteria Questionnaire
Description
FM 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
Time Frame
0.5 hours
Title
Response to the Center for Epidemiological Studies (CES-D) Depression Questionnaire
Description
FM 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.
Time Frame
0.5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melyssa Godfrey, BS
Phone
352-265-8901
Email
painresearch@medicine.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Staud, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melyssa Godfrey
Phone
352-265-8901
Email
Melyssa.Godfrey@medicine.ufl.edu
First Name & Middle Initial & Last Name & Degree
Roland Staud, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18448779
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.
Results Reference
background
PubMed Identifier
18280211
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.
Results Reference
background
PubMed Identifier
30638704
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.
Results Reference
background
PubMed Identifier
12670665
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.
Results Reference
background

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Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome

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