- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02240303
Pain, Brain and Mobility Study (PBAM)
16. Februar 2016 aktualisiert von: 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.
Studienübersicht
Status
Zurückgezogen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
65 Jahre und älter (Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Older adults
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Brain magnetic resonance imaging (MRI)
Zeitfenster: Baseline and 12 months later
|
Differences in the MRI on the brain scans of participants with greater pain severity
|
Baseline and 12 months later
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Inflammatory markers in blood samples
Zeitfenster: 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 Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Mobility (gait speed)
Zeitfenster: Baseline and 12 months
|
Inverse dynamics will be used to calculate gait speed.
|
Baseline and 12 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Yenisel Cruz-Almeida, MSPH, PhD, University of Florida
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. April 2015
Primärer Abschluss (Tatsächlich)
1. April 2015
Studienabschluss (Tatsächlich)
1. April 2015
Studienanmeldedaten
Zuerst eingereicht
2. September 2014
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
11. September 2014
Zuerst gepostet (Schätzen)
15. September 2014
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
18. Februar 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. Februar 2016
Zuletzt verifiziert
1. Februar 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 201400471
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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