coffee-cup: Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Cognitive function before opioid reduction [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 Outcome Measures
- 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)]
Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
- 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)]
Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
- Executive function before opioid reduction [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
- 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 measured by Trail making test A and B
- 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)]
Executive function measured by Trail making test A and B
- Morphine use before reduction [At first visit to pain clinic (Individual date, inclusion is possible throughout study period)]
Morphine equivalents before reduction
- 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)]
Morphine equivalents after reduction
- Use of other analgesics before reduction [At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)]
Use of any other analgesic
- 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)]
Use of any other analgesic
- 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)]
Use of any other analgesic
- Quality of life before reduction [At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)]
Quality of life measured by SF36
- 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)]
Quality of life measured by SF36
- 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)]
Quality of life measured by SF36
- Risk of anxiety and depression before reduction [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
- 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)]
Risk of anxiety and depression measured by Hospital anxiety and depression scale
- 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)]
Risk of anxiety and depression measured by Hospital anxiety and depression scale
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Holbæk Hospital | Holbæk | Denmark | 4300 | |
| 2 | Zealand University Hospital | Køge | Denmark | 4600 |
Sponsors and Collaborators
- Zealand University Hospital
Investigators
- Principal Investigator: Stine Estrup, MD, Zealand University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SE-4-2016