- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03036917
Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain (coffee-cup)
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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Holbæk, Danmark, 4300
- Holbæk Hospital
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Køge, Danmark, 4600
- Zealand University Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Cognitive function before opioid reduction
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Cognitive function at halfway point
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Stine Estrup, MD, Zealand University Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SE-4-2016
Plan för individuella deltagardata (IPD)
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