Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Central Mechanisms of Chronic Pain and Fatigue Subtitle: Functional Imaging of Brain and Spinal Cord

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03075254
Recruitment Status : Enrolling by invitation
First Posted : March 9, 2017
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Florida

Brief 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. Functional brain imaging will be used to characterized brain and spinal cord abnormalities that contribute to the mechanisms of these disorders.

Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Fibromyalgia Device: A Peltier for Sensory testing Device: functional magnetic resonance imaging for Brain Neuroimaging Device: fMRI for Spinal Cord Neuroimaging Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Central Mechanisms of Chronic Pain and Fatigue Subtitle: Functional Imaging of Brain and Spinal Cord
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Healthy Control
normal volunteers (HC) Undergoing sensory testing, brain and spinal cord neuroimaging and Inventory assessments.
Device: A Peltier for Sensory testing
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.
Other Name: Heat Foil device

Device: functional magnetic resonance imaging for Brain Neuroimaging
to evaluate baseline changes in regional cerebral blood flow to nociceptive thermal stimuli applied to the extremities of FM patients and healthy volunteers.
Other Name: fMRI

Device: fMRI for Spinal Cord Neuroimaging
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.
Other Name: functional magnetic resonance imaging

Experimental: 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.
Device: A Peltier for Sensory testing
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.
Other Name: Heat Foil device

Device: functional magnetic resonance imaging for Brain Neuroimaging
to evaluate baseline changes in regional cerebral blood flow to nociceptive thermal stimuli applied to the extremities of FM patients and healthy volunteers.
Other Name: fMRI

Device: fMRI for Spinal Cord Neuroimaging
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.
Other Name: functional magnetic resonance imaging

Experimental: 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.
Device: A Peltier for Sensory testing
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.
Other Name: Heat Foil device

Device: functional magnetic resonance imaging for Brain Neuroimaging
to evaluate baseline changes in regional cerebral blood flow to nociceptive thermal stimuli applied to the extremities of FM patients and healthy volunteers.
Other Name: fMRI

Device: fMRI for Spinal Cord Neuroimaging
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.
Other Name: functional magnetic resonance imaging




Primary Outcome Measures :
  1. Change in experimental pain from heat pulses 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

  2. 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


Secondary Outcome Measures :
  1. Change in Fatigue Ratings [ Time Frame: baseline and up to 3 hours. ]
    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"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Elavil 10 mg/day, trazodone 50 mg/day, celexa 20 mg/day

Exclusion Criteria:

  • Patients unwilling or unable to discontinue or modify analgesics, hypnotics, anxiolytics, or anti-depressants during the study period will be excluded from this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075254


Locations
Layout table for location information
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Institute of Nursing Research (NINR)
Investigators
Layout table for investigator information
Principal Investigator: Roland Staud, MD University of Florida

Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03075254     History of Changes
Other Study ID Numbers: IRB201602417 -N-A
R01NR014049 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Florida:
Pain
Fatigue
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatigue Syndrome, Chronic
Fatigue
Chronic Pain
Fibromyalgia
Signs and Symptoms
Pain
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Virus Diseases
Encephalomyelitis
Central Nervous System Diseases