Predictive Markers of the Effects of Opioid Therapy (ABILITY)
11 de mayo de 2016 actualizado por: 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
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
62
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Pellenberg
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Leuven, Pellenberg, Bélgica, 3212
- KU Leuven and the Leuven Centre for Algology & Pain Management
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Aarhus C, Dinamarca, 8000
- Department of Rheumatology, Aarhus University Hospital
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Give, Dinamarca, 7323
- Friklinikken
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Ringsted, Dinamarca, 4100
- Hospitalet Valdemar
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Ljubljana, Eslovenia, 1000
- Ljubljana University Medical Centre, Department of Anaesthetics and Surgical Intensive Care
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Reduction of chronic pain assessed by 0-10 numerical rating scale (NRS) scores
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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BPI worst pain in the past week
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Until 14 days post-treatment
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Until 14 days post-treatment
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Adverse events
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Asbjørn M Drewes, MD, PhD, DMSci, Aalborg University Hospital, Denmark
- Director de estudio: Anne E Olesen, MSc (Pharm), PhD, Aalborg University Hospital, Denmark
- Director de estudio: Kasper Grosen, MHSc, PhD, Aarhus University / Aarhus University Hospital, Denmark
- Investigador principal: Mogens Pfeiffer-Jensen, MD, PhD, Aarhus University Hospital, Denmark
- Investigador principal: Michael Kamp-Jensen, MD, PhD, Hospitalet Valdemar, Denmark
- Investigador principal: Bart Morlion, MD, PhD, University of Leuven / University Hospitals Leuven, Belgium
- Investigador principal: Gorazd Pozlep, MD, Ljubljana University Medical Centre, Slovenia
- Investigador principal: Torsten Jonsson, MD, Hospitalet Valdemar, Denmark
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2014
Finalización primaria (Actual)
1 de septiembre de 2015
Finalización del estudio (Actual)
1 de septiembre de 2015
Fechas de registro del estudio
Enviado por primera vez
2 de diciembre de 2014
Primero enviado que cumplió con los criterios de control de calidad
3 de diciembre de 2014
Publicado por primera vez (Estimar)
4 de diciembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
12 de mayo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
11 de mayo de 2016
Última verificación
1 de mayo de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ABILITY
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