NCT03075254|Completed
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Sponsor study identifier
observational
197
1 country
1
Study Start
March 15, 2017
Actual (reported)Primary Completion
October 29, 2024
Actual (reported)Study Completion
October 29, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 29, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 23, 2017
Actual (reported)March 9, 2017
Actual (reported)March 15, 2017
Actual (reported)October 29, 2024
Actual (reported)October 29, 2024
Actual (reported)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
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
3 intervals of 30 seconds each
Change in Fatigue Ratings
baseline and up to 3 hours.
normal volunteers (HC) Undergoing sensory testing, brain and spinal cord neuroimaging and Inventory assessments.
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.
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.
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.
Residents living within driving distance of Gainesville, FL.
University of Florida
Gainesville, Florida, 32611, United States
Roland Staud, MD
University of Florida
197 participants (actual enrollment reported by the registry).
First Submitted
February 23, 2017
First Posted
March 9, 2017
Study Start
March 15, 2017
Actual (reported)to evaluate baseline changes in regional cerebral blood flow to nociceptive thermal stimuli applied to the extremities of FM patients and healthy volunteers.
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.
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Primary Completion
October 29, 2024
Actual (reported)Study Completion
October 29, 2024
Actual (reported)Last Updated
January 27, 2025
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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