Clinical PainPBAMNCT02240303
Pain, Brain and Mobility Study
An observational study of Clinical Pain and Brain and Mobility Changes, run by University of Florida.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Pain, Brain and Mobility Changes
- What is being tested?
- Quantitative Sensory Testing (QST), Physical Performance and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Older adults
Who may be able to join
- Age 65 years and older
- Willingness to participate in all study procedures
- Cognitively intact as defined by 3MS score > 80
Who cannot join
- 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
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- 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.
About this study
Official title: Central and Peripheral Mechanisms Predicting Clinical Pain and Physical Performance in Older Adults
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.
Read the 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.
- Conditions
- Clinical Pain, Brain and Mobility Changes
- Being tested
- Quantitative Sensory Testing (QST), Physical Performance, Magnetic Resonance Imaging (MRI), Blood Sample
- Keywords
- pain, mobility, brain, cognition
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Sensory Testing (QST)Procedure or surgery
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 PerformanceProcedure or surgery
Participants in both groups will have a Physical Performance test.
Magnetic Resonance Imaging (MRI)Procedure or surgery
Participants in both groups will have an magnetic resonance imaging (MRI).
Blood SampleProcedure or surgery
Participants in both groups will have blood samples taken.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Quantitative Sensory Testing (QST); Procedure: Physical Performance; Procedure: Magnetic Resonance Imaging (MRI); Procedure: Blood Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain magnetic resonance imaging (MRI)
Differences in the MRI on the brain scans of participants with greater pain severity
Measured: Baseline and 12 months later
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startApr 2015
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Consolidated study with another protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yenisel Cruz-Almeida, MSPH, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240303
- Sponsor's protocol ID
- 201400471
- Acronym
- PBAM
- Status last verified
- Feb 2016
- First submitted
- 2 Sep 2014
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central and Peripheral Mechanisms Predicting Clinical Pain and Physical Performance in Older Adults
- ClinicalTrials.gov ID
- NCT02240303
- Acronym / sponsor ID
- PBAM / 201400471
- Conditions
- Clinical Pain, Brain and Mobility Changes
- Keywords
- pain, mobility, brain, cognition
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Consolidated study with another protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Pain Group | – | Procedure: Quantitative Sensory Testing (QST), Procedure: Physical Performance, Procedure: Magnetic Resonance Imaging (MRI), Procedure: Blood SampleParticipants 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 | – | Procedure: Quantitative Sensory Testing (QST), Procedure: Physical Performance, Procedure: Magnetic Resonance Imaging (MRI), Procedure: Blood SampleParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Older adults
Key inclusion criteria (3 listed)
- Age 65 years and older
- Willingness to participate in all study procedures
- Cognitively intact as defined by 3MS score > 80
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Chronic Pain Group, No Chronic Pain Group |
| Physical PerformanceParticipants in both groups will have a Physical Performance test. | Procedure or surgery | Chronic Pain Group, No Chronic Pain Group |
| Magnetic Resonance Imaging (MRI)Participants in both groups will have an magnetic resonance imaging (MRI). | Procedure or surgery | Chronic Pain Group, No Chronic Pain Group |
| Blood SampleParticipants in both groups will have blood samples taken. | Procedure or surgery | Chronic Pain Group, No Chronic Pain Group |
Primary outcome
Brain magnetic resonance imaging (MRI)
Time frame: Baseline and 12 months later
Differences in the MRI on the brain scans of participants with greater pain severity
1 secondary outcome
Inflammatory markers in blood samples
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yenisel Cruz-Almeida, MSPH, PhD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Pain and Brain and Mobility Changes, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain magnetic resonance imaging (MRI) (time frame: Baseline and 12 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.