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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Asbjørn M Drewes, MD, PhD, DMSci | Aalborg University Hospital | Study Chair |
| Anne E Olesen, MSc (Pharm), PhD | Aalborg University Hospital | Study Director |
| Kasper Grosen, MHSc, PhD | Aarhus University / Aarhus University Hospital, Denmark | Study Director |
| Mogens Pfeiffer-Jensen, MD, PhD | Aarhus University Hospital | 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Leuven and the Leuven Centre for Algology & Pain Management | Leuven | Pellenberg | 3212 | Belgium | ||
| Friklinikken |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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:
| Until 14 days post-treatment |
| Give |
| Give |
| 7323 |
| Denmark |
| Department of Rheumatology, Aarhus University Hospital | Aarhus C | 8000 | Denmark |
| Hospitalet Valdemar | Ringsted | 4100 | Denmark |
| Ljubljana University Medical Centre, Department of Anaesthetics and Surgical Intensive Care | Ljubljana | 1000 | Slovenia |