Chronic Fatigue SyndromeNCT03075254
Central Mechanisms of Chronic Pain and Fatigue Subtitle: Functional Imaging of Brain and Spinal Cord
An observational study of Chronic Fatigue Syndrome and Fibromyalgia, run by University of Florida at 1 site in United States.
Trial summary
Chronic pain and fatigue are characterized by peripheral and central mechanisms including low pain thresholds, temporal summation, peripheral and central sensitization. This application will focus on central factors of chronic pain and fatigue. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome, Fibromyalgia
- What is being tested?
- A Peltier for Sensory testing, functional magnetic resonance imaging for Brain Neuroimaging and fMRI for Spinal Cord Neuroimaging
- Type of treatment
- Medical device
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2017to 29 Oct 2024
- Phase
- Observational
- 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
Study population: Residents living within driving distance of Gainesville, FL.
Who may be able to join
- diagnosis of FM will require a history of chronic widespread pain as well as the presence of at least eleven out of eighteen paired tender points.
- diagnosis of ME/CFS will require a history of chronic fatigue persisting or relapsing for more than 6 months as well as the presence of at least four out of eight designated symptoms.
- willing to reduce anti-depressants to low levels like amitriptyline 10 mg/day, trazodone 50 mg/day, citalopram 20 mg/day, for at least five half-lives of the medication.
Who cannot join
- Patients unwilling or unable to discontinue or modify analgesics, hypnotics, anxiolytics, or anti-depressants during the study period will be excluded from this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic pain and fatigue are characterized by peripheral and central mechanisms including low pain thresholds, temporal summation, peripheral and central sensitization. This application will focus on central factors of chronic pain and fatigue. Functional brain imaging will be used to characterized brain and spinal cord abnormalities that contribute to the mechanisms of these disorders.
Read the detailed description
Chronic fatigue (ME/CFS) and fibromyalgia syndrome (FM) are a chronic musculoskeletal pain disorder that predominantly afflicts women. Frequently associated insomnia, cognitive abnormalities, and fatigue may lead to early disability. No consistent soft tissue abnormalities have been identified so far in these patients. The cause of these disorders is unknown, no highly effective treatment is available and the current methods of diagnosis are imprecise and unreliable. The Investigators previously used quantitative sensory testing to improve upon diagnoses of these disorders by supplementing the current procedure of manipulating defined pressure points by hand and noting the presence or absence of pain. The quantitative methods of evaluation involve repetitive application of brief, non-injurious thermal/mechanical stimulation that normally produces a moderate degree of temporal summation of sensation intensity. The patients and normal control subjects will verbally rate the magnitude of late sensations elicited by each stimulus, using a numerical scale. Chronic pain in these patients results, at least partially, from exaggerated activation of central N-methyl-D-aspartate (NMDA) receptors as a result of enhanced input from unmyelinated peripheral afferent nerve fibers supplying deep tissues. Temporal summation of second pain can lead to central sensitization with subsequent signs of hyperalgesia and allodynia. Functional brain imaging of ME/CFS and FM patients, as proposed in this study, will be used to document their ratings of repetitive experimental stimuli and the resulting pain augmentation. Successful completion of this study will provide a new method for the evaluation of chronic pain/fatigue mechanism and their response to therapy.
- Conditions
- Chronic Fatigue Syndrome, Fibromyalgia
- Being tested
- A Peltier for Sensory testing, functional magnetic resonance imaging for Brain Neuroimaging, fMRI for Spinal Cord Neuroimaging
- Keywords
- Pain, Fatigue
- Medical subject headings
- Fatigue Syndrome, Chronic, Fibromyalgia, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Peltier for Sensory testingDevice
Also called Heat Foil device
Subjects will be trained to rate the magnitude of late sensations elicited following brief (700 msec) contact of a preheated thermode with the glabrous (palmar) skin of either hand/foot either numerically or using a visual analogue scale.
functional magnetic resonance imaging for Brain NeuroimagingDevice
Also called fMRI
to evaluate baseline changes in regional cerebral blood flow to nociceptive thermal stimuli applied to the extremities of FM patients and healthy volunteers.
fMRI for Spinal Cord NeuroimagingDevice
Also called functional magnetic resonance imaging
The subjects will be positioned supine and immobilized by means of a padded head support. The spinous process of the first thoracic vertebra (T1) will be aligned with the center of surface Neuro - coil. This coil will be employed for both transmission of radio-frequency (RF) pulses and detection of the magnetic resonance (MR) signal. A modified FLASH sequence will be employed to obtain Blood Oxygen Level Dependent (BOLD)-sensitive images of the spinal cord.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | normal volunteers (HC) Undergoing sensory testing, brain and spinal cord neuroimaging and Inventory assessments. Receives: Device: A Peltier for Sensory testing; Device: functional magnetic resonance imaging for Brain Neuroimaging; Device: fMRI for Spinal Cord Neuroimaging | |
| Fibromyalgia Only | The diagnosis of FM will require a history of chronic widespread pain as well as the presence of at least eleven out of eighteen paired tender points. Undergoing sensory testing, brain and spinal cord neuroimaging and Inventory assessments. Receives: Device: A Peltier for Sensory testing; Device: functional magnetic resonance imaging for Brain Neuroimaging; Device: fMRI for Spinal Cord Neuroimaging | |
| Chronic fatigue and Fibromyalgia Syndrome | Diagnosis of ME/CFS will require a history of chronic fatigue persisting or relapsing for more than 6 months as well as the presence of at least four out of eight designated symptoms. Undergoing sensory testing, brain and spinal cord neuroimaging and Inventory assessments. Receives: Device: A Peltier for Sensory testing; Device: functional magnetic resonance imaging for Brain Neuroimaging; Device: fMRI for Spinal Cord Neuroimaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in experimental pain from heat pulses to the upper extremities
Numerical ratings from 0 to 100 are tied to verbal descriptors in increments of 5, to standardize the scale, and ratings in increments of 5 are permitted. Ratings of 0 and 15 designate non-painful sensations of warmth (5 = threshold for warmth, 15 = suprathreshold warmth). A rating of 20 = threshold for heat pain, 30 = very weak pain, 40 = weak pain, 50 = moderate pain, 60 = slightly strong pain, 70 = strong pain, 80 = very strong pain, 90 = extreme strong pain, and 100 = the most intense pain imaginable
Measured: 3 intervals of 30 seconds each
Change in experimental Pain from mechanical stimulation to the upper extremities and the shoulder
Numerical ratings from 0 to 100 are tied to verbal descriptors in increments of 5, to standardize the scale, and ratings in increments of 5 are permitted. Ratings of 0 and 15 designate non-painful sensations of warmth (5 = threshold for warmth, 15 = suprathreshold warmth). A rating of 20 = threshold for heat pain, 30 = very weak pain, 40 = weak pain, 50 = moderate pain, 60 = slightly strong pain, 70 = strong pain, 80 = very strong pain, 90 = extreme strong pain, and 100 = the most intense pain imaginable
Measured: 3 intervals of 30 seconds each
Secondary outcomes (1)
Change in Fatigue Ratings
Visual analogue scale ratings (0-10) on a 15 cm mechanical scale. The scale is limited on the left by "no fatigue at all" and on the right by "most intense fatigue imaginable"
Measured: baseline and up to 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start15 Mar 2017
- Primary completion29 Oct 2024
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 197 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
- NCT03075254
- Sponsor's protocol ID
- IRB201602417 -N-A
- Status last verified
- Jan 2025
- First submitted
- 23 Feb 2017
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Mechanisms of Chronic Pain and Fatigue Subtitle: Functional Imaging of Brain and Spinal Cord
- ClinicalTrials.gov ID
- NCT03075254
- Acronym / sponsor ID
- IRB201602417 -N-A
- Conditions
- Chronic Fatigue Syndrome, Fibromyalgia
- Keywords
- Pain, Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 9 Mar 2017 (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.
Chronic pain and fatigue are characterized by peripheral and central mechanisms including low pain thresholds, temporal summation, peripheral and central sensitization. This application will focus on central factors of chronic pain and fatigue. Functional brain imaging will be used to characterized brain and spinal cord abnormalities that contribute to the mechanisms of these disorders.
Detailed description
Chronic fatigue (ME/CFS) and fibromyalgia syndrome (FM) are a chronic musculoskeletal pain disorder that predominantly afflicts women. Frequently associated insomnia, cognitive abnormalities, and fatigue may lead to early disability. No consistent soft tissue abnormalities have been identified so far in these patients. The cause of these disorders is unknown, no highly effective treatment is available and the current methods of diagnosis are imprecise and unreliable. The Investigators previously used quantitative sensory testing to improve upon diagnoses of these disorders by supplementing the current procedure of manipulating defined pressure points by hand and noting the presence or absence of pain. The quantitative methods of evaluation involve repetitive application of brief, non-injurious thermal/mechanical stimulation that normally produces a moderate degree of temporal summation of sensation intensity. The patients and normal control subjects will verbally rate the magnitude of late sensations elicited by each stimulus, using a numerical scale. Chronic pain in these patients results, at least partially, from exaggerated activation of central N-methyl-D-aspartate (NMDA) receptors as a result of enhanced input from unmyelinated peripheral afferent nerve fibers supplying deep tissues. Temporal summation of second pain can lead to central sensitization with subsequent signs of hyperalgesia and allodynia. Functional brain imaging of ME/CFS and FM patients, as proposed in this study, will be used to document their ratings of repetitive experimental stimuli and the resulting pain augmentation. Successful completion of this study will provide a new method for the evaluation of chronic pain/fatigue mechanism and their response to therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | Device: A Peltier for Sensory testing, Device: functional magnetic resonance imaging for Brain Neuroimaging, Device: fMRI for Spinal Cord Neuroimagingnormal volunteers (HC) Undergoing sensory testing, brain and spinal cord neuroimaging and Inventory assessments. |
| Fibromyalgia Only | – | Device: A Peltier for Sensory testing, Device: functional magnetic resonance imaging for Brain Neuroimaging, Device: fMRI for Spinal Cord NeuroimagingThe diagnosis of FM will require a history of chronic widespread pain as well as the presence of at least eleven out of eighteen paired tender points. Undergoing sensory testing, brain and spinal cord neuroimaging and Inventory assessments. |
| Chronic fatigue and Fibromyalgia Syndrome | – | Device: A Peltier for Sensory testing, Device: functional magnetic resonance imaging for Brain Neuroimaging, Device: fMRI for Spinal Cord NeuroimagingDiagnosis of ME/CFS will require a history of chronic fatigue persisting or relapsing for more than 6 months as well as the presence of at least four out of eight designated symptoms. Undergoing sensory testing, brain and spinal cord neuroimaging and Inventory assessments. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents living within driving distance of Gainesville, FL.
Key inclusion criteria (3 listed)
- diagnosis of FM will require a history of chronic widespread pain as well as the presence of at least eleven out of eighteen paired tender points.
- diagnosis of ME/CFS will require a history of chronic fatigue persisting or relapsing for more than 6 months as well as the presence of at least four out of eight designated symptoms.
- willing to reduce anti-depressants to low levels like amitriptyline 10 mg/day, trazodone 50 mg/day, citalopram 20 mg/day, for at least five half-lives of the medication.
Key exclusion criteria (1 listed)
- Patients unwilling or unable to discontinue or modify analgesics, hypnotics, anxiolytics, or anti-depressants during the study period will be excluded from this trial.
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 |
|---|---|---|
| A Peltier for Sensory testingAlso: Heat Foil deviceSubjects will be trained to rate the magnitude of late sensations elicited following brief (700 msec) contact of a preheated thermode with the glabrous (palmar) skin of either hand/foot either numerically or using a visual analogue scale. | Device | Chronic fatigue and Fibromyalgia Syndrome, Fibromyalgia Only, Healthy Control |
| functional magnetic resonance imaging for Brain NeuroimagingAlso: fMRIto evaluate baseline changes in regional cerebral blood flow to nociceptive thermal stimuli applied to the extremities of FM patients and healthy volunteers. | Device | Chronic fatigue and Fibromyalgia Syndrome, Fibromyalgia Only, Healthy Control |
| fMRI for Spinal Cord NeuroimagingAlso: functional magnetic resonance imagingThe subjects will be positioned supine and immobilized by means of a padded head support. The spinous process of the first thoracic vertebra (T1) will be aligned with the center of surface Neuro - coil. This coil will be employed for both transmission of radio-frequency (RF) pulses and detection of the magnetic resonance (MR) signal. A modified FLASH sequence will be employed to obtain Blood Oxygen Level Dependent (BOLD)-sensitive images of the spinal cord. | Device | Chronic fatigue and Fibromyalgia Syndrome, Fibromyalgia Only, Healthy Control |
Primary outcome
Change in experimental pain from heat pulses to the upper extremities
Time frame: 3 intervals of 30 seconds each
Numerical ratings from 0 to 100 are tied to verbal descriptors in increments of 5, to standardize the scale, and ratings in increments of 5 are permitted. Ratings of 0 and 15 designate non-painful sensations of warmth (5 = threshold for warmth, 15 = suprathreshold warmth). A rating of 20 = threshold for heat pain, 30 = very weak pain, 40 = weak pain, 50 = moderate pain, 60 = slightly strong pain, 70 = strong pain, 80 = very strong pain, 90 = extreme strong pain, and 100 = the most intense pain imaginable
Change in experimental Pain from mechanical stimulation to the upper extremities and the shoulder
Time frame: 3 intervals of 30 seconds each
Numerical ratings from 0 to 100 are tied to verbal descriptors in increments of 5, to standardize the scale, and ratings in increments of 5 are permitted. Ratings of 0 and 15 designate non-painful sensations of warmth (5 = threshold for warmth, 15 = suprathreshold warmth). A rating of 20 = threshold for heat pain, 30 = very weak pain, 40 = weak pain, 50 = moderate pain, 60 = slightly strong pain, 70 = strong pain, 80 = very strong pain, 90 = extreme strong pain, and 100 = the most intense pain imaginable
1 secondary outcome
Change in Fatigue Ratings
Time frame: baseline and up to 3 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 27 Jan 2025.
- 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?
An observational study of Chronic Fatigue Syndrome and 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 3 inclusion and 1 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 27 Jan 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?
Change in experimental pain from heat pulses to the upper extremities (time frame: 3 intervals of 30 seconds each). 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?
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 27 Jan 2025.