Pain, Brain and Mobility Study

Withdrawn

• Conditions: Clinical Pain; Brain and Mobility Changes
• Interventions: Procedure: Quantitative Sensory Testing (QST); Procedure: Physical Performance; Procedure: Magnetic Resonance Imaging (MRI); Procedure: Blood Sample

• Registration Number: NCT02240303
• Lead Sponsor: University of Florida

Brief Summary

The aim of this project will be to document the central and peripheral mechanisms, which may predict clinical pain characteristics and associated physical performance in older adults. Although chronic pain is common among older adults, there is limited understanding on the processing of pain and the mechanisms by which it affects physical function in these individuals. The first aim of this study will be to examine predictors of clinical pain in older adults. These will include a comprehensive somatosensory assessment battery including mechanical and thermal detection and pain thresholds in older adults with and without chronic pain. The investigators will also assess basal cognitive and physical function to determine their associations with chronic pain. Finally, brain structure and function will be assessed in these older adults with and without pain.

Detailed Description

The purpose of this research study is to learn more about how pain in older individuals changes the brain and impacts a person's mobility and function. Pain is influenced by biology (like hormones), psychology (thoughts and feelings), and habits (like sleep or exercise) that may make older adults more likely to have higher or lower levels of pain.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-15
• Study Start: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-16
• Last Update Posted: 2016-02-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age 65 years and older
• Willingness to participate in all study procedures
• Cognitively intact as defined by 3MS score > 80

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Exclusion Criteria

• Failure to provide informed consent;
• 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Pain Group	Physical Performance	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.
No Chronic Pain Group	Physical Performance	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.
Chronic Pain Group	Quantitative Sensory Testing (QST)	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.
Chronic Pain Group	Magnetic Resonance Imaging (MRI)	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.
Chronic Pain Group	Blood Sample	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.
No Chronic Pain Group	Magnetic Resonance Imaging (MRI)	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.
No Chronic Pain Group	Blood Sample	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.
No Chronic Pain Group	Quantitative Sensory Testing (QST)	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.

Primary Outcome Measures

Name	Time	Method
Brain magnetic resonance imaging (MRI)	Baseline and 12 months later	Differences in the MRI on the brain scans of participants with greater pain severity

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers in blood samples	Baseline	To test the markers of pro-inflammatory (IL-1b, tumor necrosis factor (TNF-a)) and anti-inflammatory (IL-4, IL-10) with participants more sensitive to pain than the ones less sensitive to pain.