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Clinical Trials/NCT03036917
NCT03036917
Completed
Not Applicable

Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain A Prospective Cohort Study

Zealand University Hospital2 sites in 1 country50 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Nonmalignant Pain
Sponsor
Zealand University Hospital
Enrollment
50
Locations
2
Primary Endpoint
Cognitive function before opioid reduction
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
May 3, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Cognitive function before opioid reduction

Time Frame: 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)

Secondary Outcomes

  • Cognitive function at end of reduction(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))
  • Use of other analgesics before reduction(At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period))
  • Executive function before opioid reduction(At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period))
  • Quality of life at halfway point(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 halfway point(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 halfway point(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 halfway point(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(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 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 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))
  • Quality of life before reduction(At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period))
  • Quality of life at end of 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))
  • Risk of anxiety and depression at end of 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))
  • Morphine use before reduction(At first visit to pain clinic (Individual date, inclusion is possible throughout study period))
  • Use of other analgesics at halfway point(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 before reduction(At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period))

Study Sites (2)

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