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Pain, Brain and Mobility Study

Central and Peripheral Mechanisms Predicting Clinical Pain and Physical Performance in Older Adults

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02240303
Acronym
PBAM
Enrollment
0
Registered
2014-09-15
Start date
2015-04-30
Completion date
2015-04-30
Last updated
2016-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Pain, Brain and Mobility Changes

Keywords

pain, mobility, brain, cognition

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.

Interventions

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.

PROCEDUREPhysical Performance

Participants in both groups will have a Physical Performance test.

PROCEDUREMagnetic Resonance Imaging (MRI)

Participants in both groups will have an magnetic resonance imaging (MRI).

PROCEDUREBlood Sample

Participants in both groups will have blood samples taken.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Brain magnetic resonance imaging (MRI)Baseline and 12 months laterDifferences in the MRI on the brain scans of participants with greater pain severity

Secondary

MeasureTime frameDescription
Inflammatory markers in blood samplesBaselineTo 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.

Other

MeasureTime frameDescription
Mobility (gait speed)Baseline and 12 monthsInverse dynamics will be used to calculate gait speed.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026