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Pain, Brain and Mobility Study (PBAM)

16. februar 2016 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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

Observasjonsmessig

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Older adults

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Brain magnetic resonance imaging (MRI)
Tidsramme: Baseline and 12 months later
Differences in the MRI on the brain scans of participants with greater pain severity
Baseline and 12 months later

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Inflammatory markers in blood samples
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mobility (gait speed)
Tidsramme: Baseline and 12 months
Inverse dynamics will be used to calculate gait speed.
Baseline and 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2015

Primær fullføring (Faktiske)

1. april 2015

Studiet fullført (Faktiske)

1. april 2015

Datoer for studieregistrering

Først innsendt

2. september 2014

Først innsendt som oppfylte QC-kriteriene

11. september 2014

Først lagt ut (Anslag)

15. september 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

18. februar 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. februar 2016

Sist bekreftet

1. februar 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 201400471

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Clinical Pain

Kliniske studier på Quantitative Sensory Testing (QST)

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