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(Florida) Central Mechanisms of Chronic Pain and Fatigue (ME/CFS, fibromyalgia and healthies)

Discussion in 'Active Clinical Studies' started by Dolphin, Aug 10, 2017.

  1. Dolphin

    Dolphin Senior Member

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    via https://cfsme-registry.info

    Central Mechanisms of Chronic Pain and Fatigue Subtitle: Functional Imaging of Brain and Spinal Cord
    Sponsor: University of Florida Collaborator: National Institute of Nursing Research (NINR) Information provided by (Responsible Party): University of Florida PurposeChronic 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.
    Further study details as provided by University of Florida:
    Primary Outcome Measures:
    • 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
    • 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:
    • 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"
    Estimated Enrollment: 200
    Actual Study Start Date: March 15, 2017
    Estimated Study Completion Date: April 30, 2022
    Estimated Primary Completion Date: March 30, 2020 (Final data collection date for primary outcome measure)
    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.
    Ages Eligible for Study: 18 Years to 70 Years (Adult, Senior)
    Sexes Eligible for Study: All
    Accepts Healthy Volunteers: Yes
    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.
    Contacts
    Contact: Roland Staud, MD (352) 265-0139 staudr@ufl.edu
    Contact: Michael Robinson, PhD (352) 265-0139 merobin@ufl.edu
    Location: University of Florida, Gainesville, Florida, United States
     
  2. Valentijn

    Valentijn WE ARE KINA

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    Fukuda ... why do they even bother?
     
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  3. Woolie

    Woolie Gone now, hope to see you all again soon somewhere

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    There are a lot of red flags in this proposal.
    The first sentence really is gobbledygook, its a collection of buzzwords that are popularly used in pain research. Some describe relatively trivial events in healthy persons (for example, temporal summation, which occurs over minutes, not years). Others describe broad concepts that lack proper validation (for example, central sensitization).

    They seem to want to show that FM/CFS patients show abnormal temporal summation effects - perhaps either enhanced "ramping up" of pain responses with several successive repeated pain stimuli, or perhaps a longer timeframe over which the temporal summation effects work. I think they want to somehow link this with the idea of central sensitisation (even through the temporal summation effect is peripheral, not central, so I'm not really sure how the reasoning goes).

    There is no discussion of how the brain imaging will come in. So I would guess its probably going to be a fishing expedition, where the researchers will look for any differences between the patients and control groups and identify that as the locus of the central sensitization problem.

    I can't see anything useful coming out of this research. But I can see ways that the findings might be misused by those peddling psychological models of CFS/FM.
     
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  4. Valentijn

    Valentijn WE ARE KINA

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    I got a similar impression from skimming the researcher's other work. He's looking for ways to prove that pain isn't as bad as patients think it is, if it exists outside of the brain at all.
     
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  5. Snowdrop

    Snowdrop Rebel without a biscuit

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    @Woolie

    Any possibility you'd be willing to share some of your observations of this research with the named contacts?
     
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  6. alex3619

    alex3619 Senior Member

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    If we had internationally accepted standards then we could exclude Oxford and Fukuda and ensure adequate methodological progress. We are a long way from getting there yet. In the meantime we can continue to educate the scientific bodies and authorities so that this kind of thing finds it harder to get grant funding.
     
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