Predictive Markers of the Effects of Opioid Therapy

Completed

Brief 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

Recruitment & Eligibility

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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
BPI current pain in the past week	Day 14 post-treatment	Change from baseline
BPI pain severity in the past week	Day 14 post-treatment	Change from baseline
BPI worst pain in the past week	Day 14 post-treatment	Change from baseline
BPI least pain in the past week	Day 14 post-treatment	Change from baseline
BPI pain interference score	Day 14 post-treatment	Change from baseline
Improvement score	Day 14 post-treatment	Proportion with score \>4
Concomitant and rescue medication	Until 14 days post-treatment
Adverse events	Until 14 days post-treatment	Number (%) of the following: 1. Constipation 2. Dry mouth 3. Nausea/Vomiting 4. Sedation 5. Sweats 6. Bad dreams 7. Dysphoria/Delirium 8. Myoclonus/Seizures 9. Pruritus/Urticaria 10. Urinary retention

Locations (5): Ljubljana University Medical Centre, Department of Anaesthetics and Surgical Intensive Care
🇸🇮
Ljubljana, Slovenia
KU Leuven and the Leuven Centre for Algology & Pain Management
🇧🇪
Leuven, Pellenberg, Belgium
Department of Rheumatology, Aarhus University Hospital
🇩🇰
Aarhus C, Denmark
Friklinikken
🇩🇰
Give, Denmark
Hospitalet Valdemar
🇩🇰
Ringsted, Denmark