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 Type
OBSERVATIONAL
Enrollment
62
KU Leuven and the Leuven Centre for Algology & Pain Management
Leuven, Pellenberg, Belgium
Friklinikken
Give, Give, Denmark
Department of Rheumatology, Aarhus University Hospital
Aarhus C, Denmark
Hospitalet Valdemar
Ringsted, Denmark
Ljubljana University Medical Centre, Department of Anaesthetics and Surgical Intensive Care
Ljubljana, Slovenia
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.
Time frame: 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.
Time frame: After 14 days of opioid treatment
BPI worst pain in the past week
Change from baseline
Time frame: Day 14 post-treatment
BPI least pain in the past week
Change from baseline
Time frame: Day 14 post-treatment
BPI current pain in the past week
Change from baseline
Time frame: Day 14 post-treatment
BPI pain severity in the past week
Change from baseline
Time frame: Day 14 post-treatment
BPI pain interference score
Change from baseline
Time frame: Day 14 post-treatment
Improvement score
Proportion with score \>4
Time frame: Day 14 post-treatment
Concomitant and rescue medication
Time frame: Until 14 days post-treatment
Adverse events
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
Time frame: Until 14 days post-treatment
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