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Predictive Markers of the Effects of Opioid Therapy

NCT02308306 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2016-05-12

No results posted yet for this study

Summary

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

Conditions

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Asbjørn M Drewes, MD, PhD, DMSci · Aalborg University Hospital, Denmark

  • Anne E Olesen, MSc (Pharm), PhD · Aalborg University Hospital, Denmark

  • Kasper Grosen, MHSc, PhD · Aarhus University / Aarhus University Hospital, Denmark

  • Mogens Pfeiffer-Jensen, MD, PhD · Aarhus University Hospital, Denmark

  • Michael Kamp-Jensen, MD, PhD · Hospitalet Valdemar, Denmark

  • Bart Morlion, MD, PhD · University of Leuven / University Hospitals Leuven, Belgium

  • Gorazd Pozlep, MD · Ljubljana University Medical Centre, Slovenia

  • Torsten Jonsson, MD · Hospitalet Valdemar, Denmark

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Belgium
  • Denmark
  • Slovenia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02308306 on ClinicalTrials.gov