Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain (coffee-cup)
3. juli 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
50
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Holbæk, Danmark, 4300
- Holbæk Hospital
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Køge, Danmark, 4600
- Zealand University Hospital
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Cognitive function before opioid reduction
Tidsramme: 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)
|
At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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)
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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)
|
|
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).
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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)
|
|
Executive function before opioid reduction
Tidsramme: 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
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
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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)
|
|
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)
|
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Morphine use before reduction
Tidsramme: 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)
|
|
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
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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
Tidsramme: 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
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
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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)
|
|
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)
|
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Risk of anxiety and depression before reduction
Tidsramme: 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
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
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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)
|
|
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
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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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Stine Estrup, MD, Zealand University Hospital
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 (Faktiske)
1. januar 2018
Primær fullføring (Faktiske)
3. mai 2019
Studiet fullført (Faktiske)
3. mai 2019
Datoer for studieregistrering
Først innsendt
10. januar 2017
Først innsendt som oppfylte QC-kriteriene
25. januar 2017
Først lagt ut (Anslag)
31. januar 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. juli 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. juli 2019
Sist bekreftet
1. juli 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SE-4-2016
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
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