FibromyalgiaNCT04415866
Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome
A study testing Paced Auditory Serial Addition task (PASAT) in people with Fibromyalgia, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Paced Auditory Serial Addition task (PASAT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2020to 11 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Paced Auditory Serial Addition task (PASAT)
- Keywords
- central sensitization, peripheral sensitization, visual evoke potentials (VEP), quantitative sensory testing
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paced Auditory Serial Addition task (PASAT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Paced Auditory Serial Addition task (PASAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 hour
Secondary outcomes (2)
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
Measured: 0.5 hours
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.
Measured: 0.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start28 Aug 2020
- Primary completion11 Dec 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants sensitivity to pressure, heat, and light will be modulated by an attention task.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Staud, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415866
- Sponsor's protocol ID
- IRB202000992
- Status last verified
- Mar 2025
- First submitted
- 19 May 2020
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18448779Geisser 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.
PubMed 18280211Frank 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.
PubMed 30638704Geisser 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.
PubMed 12670665
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT04415866
- Acronym / sponsor ID
- IRB202000992
- Conditions
- Fibromyalgia
- Keywords
- central sensitization, peripheral sensitization, visual evoke potentials (VEP), quantitative sensory testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants sensitivity to pressure, heat, and light will be modulated by an attention task.
| Arm | Type | Receives |
|---|---|---|
| Effects of PASAT on Sensory Testing | Experimental | Behavioral: Paced Auditory Serial Addition task (PASAT)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paced 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. | Behavioural | Effects of PASAT on Sensory Testing |
Primary outcome
Verbal Pain Ratings of Painful Heat and Pressure Stimuli using a Numerical Pain Scale from 0 - 100
Time frame: 1 hour
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
Time frame: 1 hour
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.
2 secondary outcomes
Response to 2011 Fibromyalgia Criteria Questionnaire
Time frame: 0.5 hours
Response to the Center for Epidemiological Studies (CES-D) Depression Questionnaire
Time frame: 0.5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Background: PubMed 18448779Geisser 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.
- Background: PubMed 18280211Geisser 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.
- Background: PubMed 30638704Frank 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.
- Background: PubMed 12670665Geisser 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Staud, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paced Auditory Serial Addition task (PASAT) in people with Fibromyalgia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Pain Ratings of Painful Heat and Pressure Stimuli using a Numerical Pain Scale from 0 - 100 (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04415866, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.