Family Nursing Conversations Patients With Chronic Non-Cancer Pain
NCT03981302
Chronic Nonmalignant Pain
Copenhagen, Denmark
View Trial DetailsNCT Number: NCT03036917
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.
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Notify Me18 year and older
All sexes
Observational
Holbæk Hospital, Holbæk, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: 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)
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
Morphine equivalents before reduction
Time frame: 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
Time frame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Use of any other analgesic
Time frame: 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
Time frame: 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
Time frame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Quality of life measured by SF36
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Zealand University Hospital
Other
Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain A Prospective Cohort Study
Acronym: coffee-cup
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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