Predictive Markers of the Effects of Opioid Therapy (ABILITY)
11 maj 2016 uppdaterad av: University of Aarhus
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
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
62
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Pellenberg
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Leuven, Pellenberg, Belgien, 3212
- KU Leuven and the Leuven Centre for Algology & Pain Management
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Aarhus C, Danmark, 8000
- Department of Rheumatology, Aarhus University Hospital
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Give, Danmark, 7323
- Friklinikken
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Ringsted, Danmark, 4100
- Hospitalet Valdemar
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Ljubljana, Slovenien, 1000
- Ljubljana University Medical Centre, Department of Anaesthetics and Surgical Intensive Care
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Reduction of chronic pain assessed by 0-10 numerical rating scale (NRS) scores
Tidsram: After 14-days of opioid treatment
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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.
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After 14-days of opioid treatment
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Improvement of health-related quality of life assessed by QLQ-C30 scores
Tidsram: After 14 days of opioid treatment
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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.
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After 14 days of opioid treatment
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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BPI worst pain in the past week
Tidsram: Day 14 post-treatment
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Change from baseline
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Day 14 post-treatment
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BPI least pain in the past week
Tidsram: Day 14 post-treatment
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Change from baseline
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Day 14 post-treatment
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BPI current pain in the past week
Tidsram: Day 14 post-treatment
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Change from baseline
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Day 14 post-treatment
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BPI pain severity in the past week
Tidsram: Day 14 post-treatment
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Change from baseline
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Day 14 post-treatment
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BPI pain interference score
Tidsram: Day 14 post-treatment
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Change from baseline
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Day 14 post-treatment
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Improvement score
Tidsram: Day 14 post-treatment
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Proportion with score >4
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Day 14 post-treatment
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Concomitant and rescue medication
Tidsram: Until 14 days post-treatment
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Until 14 days post-treatment
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Adverse events
Tidsram: Until 14 days post-treatment
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Number (%) of the following:
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Until 14 days post-treatment
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Asbjørn M Drewes, MD, PhD, DMSci, Aalborg University Hospital, Denmark
- Studierektor: Anne E Olesen, MSc (Pharm), PhD, Aalborg University Hospital, Denmark
- Studierektor: Kasper Grosen, MHSc, PhD, Aarhus University / Aarhus University Hospital, Denmark
- Huvudutredare: Mogens Pfeiffer-Jensen, MD, PhD, Aarhus University Hospital, Denmark
- Huvudutredare: Michael Kamp-Jensen, MD, PhD, Hospitalet Valdemar, Denmark
- Huvudutredare: Bart Morlion, MD, PhD, University of Leuven / University Hospitals Leuven, Belgium
- Huvudutredare: Gorazd Pozlep, MD, Ljubljana University Medical Centre, Slovenia
- Huvudutredare: Torsten Jonsson, MD, Hospitalet Valdemar, Denmark
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2014
Primärt slutförande (Faktisk)
1 september 2015
Avslutad studie (Faktisk)
1 september 2015
Studieregistreringsdatum
Först inskickad
2 december 2014
Först inskickad som uppfyllde QC-kriterierna
3 december 2014
Första postat (Uppskatta)
4 december 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
12 maj 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 maj 2016
Senast verifierad
1 maj 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ABILITY
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