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Trial · NCT04571619

Outcomes26

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPain InterferenceThe primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions.Participants withdrew at various points during the trial. Some participants were not able to complete the PRO assessments.score on a scaleMEAN
SECONDARYPain IntensityWeeks 12, 24, and 36Participants withdrew at various points during the study. Some participants were not able to complete the PRO assessments.score on a scaleMEAN
SECONDARYPain CatastrophizingWeeks 12, 24, and 36Participants withdrew at various points throughout the study, and some participants were unable to complete the PRO assessments.score on a scaleMEAN
SECONDARYOpioid UseWeeks 12, 24, and 36
Not all participants reported opioid use, as this was not an inclusion criterion but rather a subset of the study population. This outcome was assessed only for those participants reporting opioid use at the time of enrollment.
morphine milliequivalentsMEAN
SECONDARYNumber of FallsThroughout the 36-week follow-upnumber of fallsNUMBER
SECONDARYRate of FallsThough Week 36 follow-upfalls/patient yearNUMBER
SECONDARYNumber of HospitalizationsThrough 36-week follow-uphospitalizationsNUMBER
SECONDARYRate of HospitalizationsThrough Week 36 follow-uphospitalizations/patient yearNUMBER
SECONDARYNumber of DeathsThrough the 36-week follow-updeathsNUMBER
SECONDARYRate of DeathsThrough Week 36 follow-updeaths/patient yearNUMBER
SECONDARYBuprenorphine AcceptabilityThrough Week 36proportion of participantsNUMBER
SECONDARYBuprenorphine TolerabilityThrough Week 36proportion of participantsNUMBER
SECONDARYOverall Sense of Quality of LifeWeeks 12, 24, and 36Participants withdrew at various points throughout the study, and some participants were unable to complete the PRO assessments.score on a scaleMEAN
SECONDARYPhysical FunctioningWeeks 12, 24, and 36Participants withdrew at various points during the study, and some participants were unable to complete the PRO assessments.T-scoreMEAN
SECONDARYDepressionWeeks 12, 24, and 36Participants withdrew at various points during the study, and some participants were unable to complete the PRO assessments.score on a scaleMEAN
SECONDARYAnxietyWeeks 12, 24, and 36Participants withdrew at various points throughout the trial, and some participants were unable to complete the PRO assessments.score on a scaleMEAN
SECONDARYCopingWeeks 12, 24, and 36Participants withdrew at various points throughout the trial, and some participants were unable to complete the PRO assessments.score on a scaleMEAN
SECONDARYSleep QualityWeeks 12, 24, and 36Participants withdrew at various times during the study, and some participants were unable to complete the PRO assessments.t-scoreMEAN
SECONDARYFatigueWeeks 12, 24, and 36Participants withdrew at various times during the study, and some participants were unable to complete the PRO assessments.t-scoreMEAN
SECONDARYSatisfaction With TreatmentWeeks 12, 24, and 36Participants withdrew at various times throughout the trial, and some participants were unable to complete the PRO assessments.score on a scaleMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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