Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Pain, Brain and Mobility Study (PBAM)

16 februari 2016 bijgewerkt door: University of Florida

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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Older adults

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
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.
Participants in both groups will have a Physical Performance test.
Participants in both groups will have an magnetic resonance imaging (MRI).
Participants in both groups will have blood samples taken.
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.
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.
Participants in both groups will have a Physical Performance test.
Participants in both groups will have an magnetic resonance imaging (MRI).
Participants in both groups will have blood samples taken.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Brain magnetic resonance imaging (MRI)
Tijdsspanne: Baseline and 12 months later
Differences in the MRI on the brain scans of participants with greater pain severity
Baseline and 12 months later

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Inflammatory markers in blood samples
Tijdsspanne: Baseline
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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mobility (gait speed)
Tijdsspanne: Baseline and 12 months
Inverse dynamics will be used to calculate gait speed.
Baseline and 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Yenisel Cruz-Almeida, MSPH, PhD, University of Florida

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2015

Primaire voltooiing (Werkelijk)

1 april 2015

Studie voltooiing (Werkelijk)

1 april 2015

Studieregistratiedata

Eerst ingediend

2 september 2014

Eerst ingediend dat voldeed aan de QC-criteria

11 september 2014

Eerst geplaatst (Schatting)

15 september 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

18 februari 2016

Laatste update ingediend die voldeed aan QC-criteria

16 februari 2016

Laatst geverifieerd

1 februari 2016

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 201400471

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren