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Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain (coffee-cup)

3. juli 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Holbæk, Danmark, 4300
        • Holbæk Hospital
      • Køge, Danmark, 4600
        • Zealand University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with chronic pain, treated with opioids and participating in the opioid reduction programme at the Multidiscipinary Pain Centre at Zealand University Hospital Køge

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cognitive function before opioid reduction
Tidsramme: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cognitive function at halfway point
Tidsramme: 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)
Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
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)
Cognitive function at end of reduction
Tidsramme: 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)
Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
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)
Executive function before opioid reduction
Tidsramme: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Executive function measured by Trail making test A and B
At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Executive function at halfway point
Tidsramme: 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)
Executive function measured by Trail making test A and B
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)
Executive function at end of reduction
Tidsramme: 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)
Executive function measured by Trail making test A and B
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)
Morphine use before reduction
Tidsramme: At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
Morphine equivalents before reduction
At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
Morphine use after reduction
Tidsramme: 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)
Morphine equivalents after reduction
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)
Use of other analgesics before reduction
Tidsramme: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Use of any other analgesic
At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Use of other analgesics at halfway point
Tidsramme: 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)
Use of any other analgesic
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)
Use of other analgesics after reduction
Tidsramme: 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)
Use of any other analgesic
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)
Quality of life before reduction
Tidsramme: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Quality of life measured by SF36
At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Quality of life at halfway point
Tidsramme: 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)
Quality of life measured by SF36
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)
Quality of life at end of reduction
Tidsramme: 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)
Quality of life measured by SF36
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)
Risk of anxiety and depression before reduction
Tidsramme: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Risk of anxiety and depression measured by Hospital anxiety and depression scale
At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Risk of anxiety and depression at halfway point
Tidsramme: 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)
Risk of anxiety and depression measured by Hospital anxiety and depression scale
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)
Risk of anxiety and depression at end of reduction
Tidsramme: 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)
Risk of anxiety and depression measured by Hospital anxiety and depression scale
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Zealand University Hospital

Efterforskere

  • Ledende efterforsker: Stine Estrup, MD, Zealand University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2018

Primær færdiggørelse (Faktiske)

3. maj 2019

Studieafslutning (Faktiske)

3. maj 2019

Datoer for studieregistrering

Først indsendt

10. januar 2017

Først indsendt, der opfyldte QC-kriterier

25. januar 2017

Først opslået (Skøn)

31. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2019

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SE-4-2016

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

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