Clinical trial NCT02308306: Predictive Markers of the Effects of Opioid Therapy
Official title: Predictive Markers of the Effects of Opioid Therapy in Opioid naïve Patients With Chronic Pain: an International, Multi-centre, Observational Cohort Study (ABILITY)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Analgesic Treatment Response
Chronic Pain
Keywords: Chronic pain
Opioid analgesics
Prediction study
Pharmaco-EEG
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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 outcomes:
measure: Reduction of chronic pain assessed by 0-10 numerical rating scale (NRS) scores
timeFrame: After 14-days of opioid treatment
measure: Improvement of health-related quality of life assessed by QLQ-C30 scores
timeFrame: After 14 days of opioid treatment
Secondary outcomes:
measure: BPI worst pain in the past week
timeFrame: Day 14 post-treatment
measure: BPI least pain in the past week
timeFrame: Day 14 post-treatment
measure: BPI current pain in the past week
timeFrame: Day 14 post-treatment
measure: BPI pain severity in the past week
timeFrame: Day 14 post-treatment
measure: BPI pain interference score
timeFrame: Day 14 post-treatment
measure: Improvement score
timeFrame: Day 14 post-treatment
measure: Concomitant and rescue medication
timeFrame: Until 14 days post-treatment
measure: Adverse events
timeFrame: Until 14 days post-treatment
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven and the Leuven Centre for Algology & Pain Management
state: Pellenberg
city: Aarhus C
country: Denmark
facility: Department of Rheumatology, Aarhus University Hospital
city: Give
country: Denmark
facility: Friklinikken
city: Ringsted
country: Denmark
facility: Hospitalet Valdemar
city: Ljubljana
country: Slovenia
facility: Ljubljana University Medical Centre, Department of Anaesthetics and Surgical Intensive Care
Study officials:
affiliation: Aalborg University Hospital, Denmark
name: Asbjørn M Drewes, MD, PhD, DMSci
role: STUDY_CHAIR
affiliation: Aalborg University Hospital, Denmark
name: Anne E Olesen, MSc (Pharm), PhD
role: STUDY_DIRECTOR
affiliation: Aarhus University / Aarhus University Hospital, Denmark
name: Kasper Grosen, MHSc, PhD
role: STUDY_DIRECTOR
affiliation: Aarhus University Hospital, Denmark
name: Mogens Pfeiffer-Jensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospitalet Valdemar, Denmark
name: Michael Kamp-Jensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leuven / University Hospitals Leuven, Belgium
name: Bart Morlion, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ljubljana University Medical Centre, Slovenia
name: Gorazd Pozlep, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospitalet Valdemar, Denmark
name: Torsten Jonsson, MD
role: PRINCIPAL_INVESTIGATOR
References: