Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2015-04-30
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Chronic Pain Group
Participants that experience chronic pain will have the following procedures performed: A sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin; Pressure sense will be produced by a device that will be pressed against the skin for several seconds; Pinprick pressure will be applied to determine if the pain can be rated; a Physical Performance test will be performed; and an magnetic resonance imaging (MRI) will be done. In addition, blood sample, blood pressure, heart rate, and skin temperature will be taken during the procedures.
Quantitative Sensory Testing (QST)
Participants in both groups will have a sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin.
Physical Performance
Participants in both groups will have a Physical Performance test.
Magnetic Resonance Imaging (MRI)
Participants in both groups will have an magnetic resonance imaging (MRI).
Blood Sample
Participants in both groups will have blood samples taken.
No Chronic Pain Group
Participants that do not experience chronic pain will have the following procedures performed: A sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin; Pressure sense will be produced by a device that will be pressed against the skin for several seconds; Pinprick pressure will be applied to determine if the pain can be rated; a Physical Performance test will be performed; and an magnetic resonance imaging (MRI) will be done. In addition, blood sample, blood pressure, heart rate, and skin temperature will be taken during the procedures.
Quantitative Sensory Testing (QST)
Participants in both groups will have a sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin.
Physical Performance
Participants in both groups will have a Physical Performance test.
Magnetic Resonance Imaging (MRI)
Participants in both groups will have an magnetic resonance imaging (MRI).
Blood Sample
Participants in both groups will have blood samples taken.
Interventions
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Quantitative Sensory Testing (QST)
Participants in both groups will have a sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin.
Physical Performance
Participants in both groups will have a Physical Performance test.
Magnetic Resonance Imaging (MRI)
Participants in both groups will have an magnetic resonance imaging (MRI).
Blood Sample
Participants in both groups will have blood samples taken.
Eligibility Criteria
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Inclusion Criteria
* Willingness to participate in all study procedures
* Cognitively intact as defined by 3MS score \> 80
Exclusion Criteria
* Contraindications to MRI, such as claustrophobia, heart pacemaker / defibrillator, heart valve prosthesis, aneurysm clip, metallic stent, neurostimulation system, cochlear implants or inner ear prosthesis, insulin pump or other infusion pump, metal slivers in the orbital area/eye socket
* Active treatment for cancer or history of cancer in the past year
* Severe cardiac disease, including New York Heart Association (NYHA) Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest or stroke, use of a cardiac defibrillator, or uncontrolled angina;
* Previous stroke with upper and/or lower extremities involvement within the last 6 months
* History of life-threatening cardiac arrhythmias, stroke, severe Parkinson's disease or severe neurological disorders likely to interfere with physical function
* Renal disease requiring dialysis
* Lung disease requiring steroids
* Inability to reliably rate pain intensity
* Current use of tobacco products
* Uncontrolled hypertension (BP of greater than 150/99 mm Hg)
* Serious systemic disease that restrict normal daily activities
* Neurological problems with significant changes in somatosensory and pain perception at the intended stimulation sites,
* Uncontrolled psychiatric condition (e.g., experiencing symptoms of schizophrenia, bipolar disorder, etc.) or hospitalization within the preceding year for psychiatric illness
* Daily use of narcotic medication
* Lower extremity amputation
* Uncontrolled diabetes (self-reported medication use and/or HA1C value)
* A known diagnosis of dementia
* Inability to communicate because of severe hearing loss or speech disorder;
* Severe visual impairment, which would preclude completion of the assessments and/or intervention.
65 Years
ALL
Yes
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Yenisel Cruz-Almeida, MSPH, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Other Identifiers
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201400471
Identifier Type: -
Identifier Source: org_study_id
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