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Trial · NCT03026790

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPain Response12 monthsBinary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline
Secondary50% Reduction in Opioid Daily Dose12 monthsBinary response variable defined by reduction of at least 50% in opioid daily dose (morphine-equivalent mg) from baseline
SecondaryComposite Response12 monthsBinary composite response variable defined by achieving at least a 30% reduction in BPI total score and at least 50% reduction in opioid daily dose from baseline.
SecondaryBrief Pain Inventory (BPI) Total Score12 monthsBrief Pain Inventory (BPI) total score calculated as average of 11 items (range 0-10; higher is worse)
OtherVR-12 Physical Component Score12 monthsVeterans RAND 12-item health survey (VR-12) Physical Component Score (range 0-100; higher is better)
OtherSymptom Checklist12 monthsMedication-related adverse symptoms count (0-19; higher is worse)
OtherPODS Problems12 monthsPrescribed Opioids Difficulty Scale (PODS) Problems score (range 0-32; higher is worse)
OtherPHQ-812 monthsPatient Health Questionnaire 8-item (PHQ-8) depression scale score (range 0-24; higher is worse)
OtherGAD-712 monthsGeneral Anxiety Disorders 7-item questionnaire (GAD-7) score (range 0-21; higher is worse)
OtherPROMIS Sleep Disturbance12 months
Patient Reported Outcomes Measurement Information System (PROMIS) sleep disturbance short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean.
OtherPROMIS Fatigue12 months
Patient Reported Outcomes Measurement Information System (PROMIS) fatigue short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean.
OtherHeadache Impact Test12 monthsHeadache Impact Test score (range 36-78; higher is worse)
OtherVR-12 Mental Component Score12 monthsVeterans RAND 12-item health survey (VR-12) Mental Component Score (range 0-100; higher is better)
OtherPODS Concerns12 monthsPrescribed Opioids Difficulty Scale (PODS) Concerns score (range 0-28; higher is worse)

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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