Pain, Brain and Mobility Study

Brain and Mobility Changes Clinical Trial

— PBAM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02240303
• Other study ID #: 201400471
• Status: Withdrawn
• Phase: N/A
• First received: September 2, 2014
• Last updated: February 16, 2016
• Start date: April 2015
• Est. completion date: April 2015

Study information

• Verified date: February 2016
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain and Mobility Changes
• Clinical Pain

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mobility (gait speed)	Inverse dynamics will be used to calculate gait speed.	Baseline and 12 months	No
Primary	Brain magnetic resonance imaging (MRI)	Differences in the MRI on the brain scans of participants with greater pain severity	Baseline and 12 months later	No
Secondary	Inflammatory markers in blood samples	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.	Baseline	No