Predictive Markers of the Effects of Opioid Therapy (ABILITY)

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Opioid Analgesic Treatment Response

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Belgium
  • Pellenberg
    • Leuven, Pellenberg, Belgium, 3212
      • KU Leuven and the Leuven Centre for Algology & Pain Management
• Denmark
  • Aarhus C, Denmark, 8000
    • Department of Rheumatology, Aarhus University Hospital
  • Give, Denmark, 7323
    • Friklinikken
  • Ringsted, Denmark, 4100
    • Hospitalet Valdemar
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Ljubljana University Medical Centre, Department of Anaesthetics and Surgical Intensive Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of chronic pain assessed by 0-10 numerical rating scale (NRS) scores	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.	After 14-days of opioid treatment
Improvement of health-related quality of life assessed by QLQ-C30 scores	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.	After 14 days of opioid treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BPI worst pain in the past week	Change from baseline	Day 14 post-treatment
BPI least pain in the past week	Change from baseline	Day 14 post-treatment
BPI current pain in the past week	Change from baseline	Day 14 post-treatment
BPI pain severity in the past week	Change from baseline	Day 14 post-treatment
BPI pain interference score	Change from baseline	Day 14 post-treatment
Improvement score	Proportion with score >4	Day 14 post-treatment
Concomitant and rescue medication		Until 14 days post-treatment
Adverse events	Number (%) of the following: Constipation; Dry mouth; Nausea/Vomiting; Sedation; Sweats; Bad dreams; Dysphoria/Delirium; Myoclonus/Seizures; Pruritus/Urticaria; Urinary retention	Until 14 days post-treatment

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Study Chair: Asbjørn M Drewes, MD, PhD, DMSci, Aalborg University Hospital, Denmark; Study Director: Anne E Olesen, MSc (Pharm), PhD, Aalborg University Hospital, Denmark; Study Director: Kasper Grosen, MHSc, PhD, Aarhus University / Aarhus University Hospital, Denmark; Principal Investigator: Mogens Pfeiffer-Jensen, MD, PhD, Aarhus University Hospital, Denmark; Principal Investigator: Michael Kamp-Jensen, MD, PhD, Hospitalet Valdemar, Denmark; Principal Investigator: Bart Morlion, MD, PhD, University of Leuven / University Hospitals Leuven, Belgium; Principal Investigator: Gorazd Pozlep, MD, Ljubljana University Medical Centre, Slovenia; Principal Investigator: Torsten Jonsson, MD, Hospitalet Valdemar, Denmark

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: December 2, 2014
• First Submitted That Met QC Criteria: December 3, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Chronic pain; Opioid analgesics; Prediction study; Pharmaco-EEG
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: ABILITY