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Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain (coffee-cup)

3 juillet 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

50

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Danemark
      • Holbæk, Danemark, 4300
        • Holbæk Hospital
      • Køge, Danemark, 4600
        • Zealand University Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Patients with chronic pain, treated with opioids and participating in the opioid reduction programme at the Multidiscipinary Pain Centre at Zealand University Hospital Køge

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: Cohorte
  • Perspectives temporelles: Éventuel

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Cognitive function before opioid reduction
Délai: 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)
At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Cognitive function at halfway point
Délai: 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)
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
Délai: 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).
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 before opioid reduction
Délai: 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
At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Executive function at halfway point
Délai: 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
Délai: 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
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 before reduction
Délai: At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
Morphine equivalents before reduction
At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
Morphine use after reduction
Délai: 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
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 before reduction
Délai: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Use of any other analgesic
At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Use of other analgesics at halfway point
Délai: 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
Délai: 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
Délai: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Quality of life measured by SF36
At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Quality of life at halfway point
Délai: 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
Délai: 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
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 before reduction
Délai: 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
At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Risk of anxiety and depression at halfway point
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Zealand University Hospital

Les enquêteurs

  • Chercheur principal: Stine Estrup, MD, Zealand University Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2018

Achèvement primaire (Réel)

3 mai 2019

Achèvement de l'étude (Réel)

3 mai 2019

Dates d'inscription aux études

Première soumission

10 janvier 2017

Première soumission répondant aux critères de contrôle qualité

25 janvier 2017

Première publication (Estimation)

31 janvier 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 juillet 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 juillet 2019

Dernière vérification

1 juillet 2018

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SE-4-2016

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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