Clinical trial NCT02240303: Pain, Brain and Mobility Study
Official title: Central and Peripheral Mechanisms Predicting Clinical Pain and Physical Performance in Older Adults
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Clinical Pain
Brain and Mobility Changes
Keywords: pain
mobility
brain
cognition
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults

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.

Eligibility criteria: Inclusion Criteria:

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

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.

Primary outcomes:
measure: Brain magnetic resonance imaging (MRI)
timeFrame: Baseline and 12 months later
Secondary outcomes:
measure: Inflammatory markers in blood samples
timeFrame: Baseline
Other outcomes:
measure: Mobility (gait speed)
timeFrame: Baseline and 12 months
Locations:
Study officials:
affiliation: University of Florida
name: Yenisel Cruz-Almeida, MSPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: