Pain, Brain and Mobility Study

NCT02240303 | Withdrawn

• 1 other identifier: 201400471
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Clinical Pain; Brain and Mobility Changes

Keywords

pain; mobility; brain; cognition

Outcome Measures

Primary Outcomes (1)

• Brain magnetic resonance imaging (MRI)

  Differences in the MRI on the brain scans of participants with greater pain severity

  Baseline and 12 months later

Secondary Outcomes (1)

• Inflammatory markers in blood samples

  Baseline

Other Outcomes (1)

• Mobility (gait speed)

  Baseline and 12 months

Study Arms (2)

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.

Procedure: Quantitative Sensory Testing (QST); Procedure: Physical Performance; Procedure: Magnetic Resonance Imaging (MRI); Procedure: Blood Sample

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.

Procedure: Quantitative Sensory Testing (QST); Procedure: Physical Performance; Procedure: Magnetic Resonance Imaging (MRI); Procedure: Blood Sample

Interventions

Quantitative Sensory Testing (QST) PROCEDURE

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.

Chronic Pain Group; No Chronic Pain Group

Physical Performance PROCEDURE

Participants in both groups will have a Physical Performance test.

Chronic Pain Group; No Chronic Pain Group

Magnetic Resonance Imaging (MRI) PROCEDURE

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

Chronic Pain Group; No Chronic Pain Group

Blood Sample PROCEDURE

Participants in both groups will have blood samples taken.

Chronic Pain Group; No Chronic Pain Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples will be stored.

MeSH Terms

Conditions

Pain

Interventions

Physical Functional Performance; Magnetic Resonance Spectroscopy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Fitness; Health; Population Characteristics; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Yenisel Cruz-Almeida, MSPH, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 15, 2014
• Study Start: April 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 18, 2016

Record last verified: 2016-02