Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain (coffee-cup)
2019年7月3日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (実際)
50
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
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Holbæk、デンマーク、4300
- Holbæk Hospital
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Køge、デンマーク、4600
- Zealand University Hospital
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Patients with chronic pain, treated with opioids and participating in the opioid reduction programme at the Multidiscipinary Pain Centre at Zealand University Hospital Køge
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cognitive function before opioid reduction
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cognitive function at halfway point
時間枠：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
時間枠：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
時間枠：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)
|
|
Executive function at halfway point
時間枠：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
|
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
時間枠：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
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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
時間枠：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
時間枠：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
時間枠：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)
|
|
Use of other analgesics at halfway point
時間枠：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
|
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
時間枠：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
時間枠：At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
|
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)
|
|
Quality of life at halfway point
時間枠：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
時間枠：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
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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
時間枠：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)
|
|
Risk of anxiety and depression at halfway point
時間枠：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
|
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
時間枠：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
|
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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Stine Estrup, MD、Zealand University Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年1月1日
一次修了 (実際)
2019年5月3日
研究の完了 (実際)
2019年5月3日
試験登録日
最初に提出
2017年1月10日
QC基準を満たした最初の提出物
2017年1月25日
最初の投稿 (見積もり)
2017年1月31日
学習記録の更新
投稿された最後の更新 (実際)
2019年7月5日
QC基準を満たした最後の更新が送信されました
2019年7月3日
最終確認日
2018年7月1日
詳しくは
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