Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain (coffee-cup)
3. Juli 2019 aktualisiert von: Zealand University Hospital
Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain A Prospective Cohort Study
This study aims to investigate the cognitive function of patients in the opioid reduction programme at the multidisciplinary pain centre at Zealand University Hospital Køge.
The patients will be tested before, halfway through, and after the programme.
Studienübersicht
Status
Abgeschlossen
Detaillierte Beschreibung
The number of patients with chronic non-malignant pain is high and constant. An estimated 3-5% of the population use opioids daily. These patients have a lower quality of life and a higher use of healthcare services.
This leads to enormous costs, both human and economic. Many patients lose their ability to work, not only because of the pain, but also because of their treatment.
For a long period, opioids have been prescribed for chronic pain, even though the evidence is scarce.
A rising conscience about opioid use is on the way, and now, there is a tendency to reduce, rather than increase opioids.
The reasons are many: Constipation, inability to drive, a sense of drowsiness and no relief of pain, just to name a few. Furthermore, opioids may have decreased effect over time or may even lead to higher levels of pain.
Many patients are at first reluctant to start the reduction programme. Mostly because the patients may not be aware of the effects, the drugs are having on them. Many patients value their opioid treatment as positive and necessary, in spite of the many adverse effects.
The investigators wanted to test the cognitive function of patients before, during and after opioid reduction. The results can be used to help patients understand the deleterious effects of high opioid usage, and can also be used to motivate the individual patient along the way.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
50
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Holbæk, Dänemark, 4300
- Holbæk Hospital
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Køge, Dänemark, 4600
- Zealand University Hospital
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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
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Patients with chronic pain, treated with opioids and participating in the opioid reduction programme at the Multidiscipinary Pain Centre at Zealand University Hospital Køge
Beschreibung
Inclusion Criteria:
- Patients > 18 years of age and able to provide a written consent
- Participating in the opioid reduction programme
Exclusion Criteria:
- Not able to speak and understand Danish
- Patients suffering from dementia or psychosis
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Interessent
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Cognitive function before opioid reduction
Zeitfenster: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
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At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Cognitive function at halfway point
Zeitfenster: When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
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Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
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When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
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Cognitive function at end of reduction
Zeitfenster: When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
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Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
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When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
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Executive function before opioid reduction
Zeitfenster: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Executive function measured by Trail making test A and B
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At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Executive function at halfway point
Zeitfenster: When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
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Executive function measured by Trail making test A and B
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When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
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Executive function at end of reduction
Zeitfenster: When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
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Executive function measured by Trail making test A and B
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When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
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Morphine use before reduction
Zeitfenster: At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
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Morphine equivalents before reduction
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At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
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Morphine use after reduction
Zeitfenster: At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
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Morphine equivalents after reduction
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At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
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Use of other analgesics before reduction
Zeitfenster: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Use of any other analgesic
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At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Use of other analgesics at halfway point
Zeitfenster: When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
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Use of any other analgesic
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When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
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Use of other analgesics after reduction
Zeitfenster: At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
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Use of any other analgesic
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At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
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Quality of life before reduction
Zeitfenster: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Quality of life measured by SF36
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At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Quality of life at halfway point
Zeitfenster: When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
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Quality of life measured by SF36
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When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
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Quality of life at end of reduction
Zeitfenster: At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
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Quality of life measured by SF36
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At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
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Risk of anxiety and depression before reduction
Zeitfenster: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Risk of anxiety and depression measured by Hospital anxiety and depression scale
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At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Risk of anxiety and depression at halfway point
Zeitfenster: When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
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Risk of anxiety and depression measured by Hospital anxiety and depression scale
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When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
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Risk of anxiety and depression at end of reduction
Zeitfenster: At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
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Risk of anxiety and depression measured by Hospital anxiety and depression scale
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At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Stine Estrup, MD, Zealand University Hospital
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 (Tatsächlich)
1. Januar 2018
Primärer Abschluss (Tatsächlich)
3. Mai 2019
Studienabschluss (Tatsächlich)
3. Mai 2019
Studienanmeldedaten
Zuerst eingereicht
10. Januar 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
25. Januar 2017
Zuerst gepostet (Schätzen)
31. Januar 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
5. Juli 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. Juli 2019
Zuletzt verifiziert
1. Juli 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SE-4-2016
Plan für individuelle Teilnehmerdaten (IPD)
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