Predictive Markers of the Effects of Opioid Therapy (ABILITY)
11. mai 2016 oppdatert 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
Studieoversikt
Status
Fullført
Studietype
Observasjonsmessig
Registrering (Faktiske)
62
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pellenberg
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Leuven, Pellenberg, Belgia, 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, Slovenia, 1000
- Ljubljana University Medical Centre, Department of Anaesthetics and Surgical Intensive Care
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Reduction of chronic pain assessed by 0-10 numerical rating scale (NRS) scores
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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BPI worst pain in the past week
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Until 14 days post-treatment
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Until 14 days post-treatment
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Adverse events
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Asbjørn M Drewes, MD, PhD, DMSci, Aalborg University Hospital, Denmark
- Studieleder: Anne E Olesen, MSc (Pharm), PhD, Aalborg University Hospital, Denmark
- Studieleder: Kasper Grosen, MHSc, PhD, Aarhus University / Aarhus University Hospital, Denmark
- Hovedetterforsker: Mogens Pfeiffer-Jensen, MD, PhD, Aarhus University Hospital, Denmark
- Hovedetterforsker: Michael Kamp-Jensen, MD, PhD, Hospitalet Valdemar, Denmark
- Hovedetterforsker: Bart Morlion, MD, PhD, University of Leuven / University Hospitals Leuven, Belgium
- Hovedetterforsker: Gorazd Pozlep, MD, Ljubljana University Medical Centre, Slovenia
- Hovedetterforsker: Torsten Jonsson, MD, Hospitalet Valdemar, Denmark
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2014
Primær fullføring (Faktiske)
1. september 2015
Studiet fullført (Faktiske)
1. september 2015
Datoer for studieregistrering
Først innsendt
2. desember 2014
Først innsendt som oppfylte QC-kriteriene
3. desember 2014
Først lagt ut (Anslag)
4. desember 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
12. mai 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mai 2016
Sist bekreftet
1. mai 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ABILITY
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