Predictive Markers of the Effects of Opioid Therapy (ABILITY)
11 mai 2016 mis à jour par: University of Aarhus
Predictive Markers of the Effects of Opioid Therapy in Opioid naïve Patients With Chronic Pain: an International, Multi-centre, Observational Cohort Study (ABILITY)
The overall goal of the ABILITY study is to help improve pain diagnostics and treatment by developing an implementable clinical computerised decision support system based on individual patient characteristics.
The investigators hypothesize that successful pain control with opioids can be predicted before treatment initiation with advanced data analyses of data originating from pre-treatment EEG, QST and pain-related catastrophic thinking.
The primary objective of this study is the identification of markers that can be used to individualize treatment recommendations, i.e. to reliably predict the response of pain to opioids.
Markers are selected among the most promising data and machine-learning methods are used for the prediction. This includes determining the associations between a battery of selected pre-treatment clinical predictive markers and the analgesic effect of opioid treatment in opioid naïve chronic pain patients, including indication and responder identification.
The key secondary objectives are as follows: to investigate pre-treatment clinical predictive markers as predictors of opioid treatment efficacy and effectiveness in terms of the following:
- Pain intensity and unpleasantness
- Use of rescue analgesics
- Physical functioning
- Global improvement and satisfaction with treatment
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Observationnel
Inscription (Réel)
62
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
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Pellenberg
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Leuven, Pellenberg, Belgique, 3212
- KU Leuven and the Leuven Centre for Algology & Pain Management
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Aarhus C, Danemark, 8000
- Department of Rheumatology, Aarhus University Hospital
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Give, Danemark, 7323
- Friklinikken
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Ringsted, Danemark, 4100
- Hospitalet Valdemar
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Ljubljana, Slovénie, 1000
- Ljubljana University Medical Centre, Department of Anaesthetics and Surgical Intensive Care
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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
Subjects with an insufficiently treated chronic pain condition (with non-opioids ± adjuvants), and expected to benefit from the administration of opioids (as necessary) to obtain freedom from pain.
La description
Inclusion Criteria:
- Pain duration ≥ 3 months.
- Minimum baseline pain intensity ≥ 4 on a 0-10 numerical rating scale (over the past week).
- Maximum baseline pain intensity < 9 on a 0-10 numerical rating scale (over the past week).
- Prescribed opioid treatment (ATC: N02)
- Anticipated to stay on prescribed opioid treatment throughout the study, i.e. >14 days.
- Anticipated to stay on any concomitant non-opioid treatment throughout the study, i.e. >14 days.
- Subject may be male or female, age >18 years old.
- Is willing and able to comply with study procedures as judged by the site investigator.
- Subject has voluntarily signed and dated the study-specific informed consent form, approved by an Independent Ethics Committee, after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent form must be signed before any study-specific procedures are performed.
Exclusion Criteria:
- Has a mental incapacity or language barriers precluding adequate understanding of study procedures.
- Is considered by the site investigator unsuitable to participate in the study for any other reason, for instance due to a significant serious underlying condition.
- Recently received opioids on a daily basis (within the last 10 weeks).
- Current alcohol or substance abuse, according to the site investigator's medical judgement.
- Is anticipated to undergo a painful procedure(s) (e.g. surgery) during the study, which can interfere with the experience of the chronic pain condition for which the subject is to receive opioids.
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
Cohortes et interventions
Groupe / Cohorte |
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Opioid analgesics
Opioid treatment is determined, prescribed, modified and discontinued at the sole discretion of the treating physician at each research site; regardless of generic name, manufacturer, constituent components, route of administration, and dosing schedule (including titration and run-in periods).
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Reduction of chronic pain assessed by 0-10 numerical rating scale (NRS) scores
Délai: After 14-days of opioid treatment
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The absolute and percentage change from baseline in ratings of average pain in the past week at Day 14.
Of note, a percentage change of ≥30% is considered clinically significant.
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After 14-days of opioid treatment
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Improvement of health-related quality of life assessed by QLQ-C30 scores
Délai: After 14 days of opioid treatment
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The absolute and percentage change from baseline in ratings of health-related quality of life in the past week at Day 14.
A subjectively significant change in QLQ-C30 scores is one that is ≥10 from baseline.
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After 14 days of opioid treatment
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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BPI worst pain in the past week
Délai: Day 14 post-treatment
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Change from baseline
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Day 14 post-treatment
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BPI least pain in the past week
Délai: Day 14 post-treatment
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Change from baseline
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Day 14 post-treatment
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BPI current pain in the past week
Délai: Day 14 post-treatment
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Change from baseline
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Day 14 post-treatment
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BPI pain severity in the past week
Délai: Day 14 post-treatment
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Change from baseline
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Day 14 post-treatment
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BPI pain interference score
Délai: Day 14 post-treatment
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Change from baseline
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Day 14 post-treatment
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Improvement score
Délai: Day 14 post-treatment
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Proportion with score >4
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Day 14 post-treatment
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Concomitant and rescue medication
Délai: Until 14 days post-treatment
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Until 14 days post-treatment
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Adverse events
Délai: Until 14 days post-treatment
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Number (%) of the following:
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Until 14 days post-treatment
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Asbjørn M Drewes, MD, PhD, DMSci, Aalborg University Hospital, Denmark
- Directeur d'études: Anne E Olesen, MSc (Pharm), PhD, Aalborg University Hospital, Denmark
- Directeur d'études: Kasper Grosen, MHSc, PhD, Aarhus University / Aarhus University Hospital, Denmark
- Chercheur principal: Mogens Pfeiffer-Jensen, MD, PhD, Aarhus University Hospital, Denmark
- Chercheur principal: Michael Kamp-Jensen, MD, PhD, Hospitalet Valdemar, Denmark
- Chercheur principal: Bart Morlion, MD, PhD, University of Leuven / University Hospitals Leuven, Belgium
- Chercheur principal: Gorazd Pozlep, MD, Ljubljana University Medical Centre, Slovenia
- Chercheur principal: Torsten Jonsson, MD, Hospitalet Valdemar, Denmark
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
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
1 octobre 2014
Achèvement primaire (Réel)
1 septembre 2015
Achèvement de l'étude (Réel)
1 septembre 2015
Dates d'inscription aux études
Première soumission
2 décembre 2014
Première soumission répondant aux critères de contrôle qualité
3 décembre 2014
Première publication (Estimation)
4 décembre 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
12 mai 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 mai 2016
Dernière vérification
1 mai 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ABILITY
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