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Trial · NCT04230577

Registered outcomes92

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

ListOutcomeTime frameDescription
SecondaryShort Form, McGill Pain Questionnaire 1Change from Pre-Treatment Baseline to 1-Week after Series 1Pain Rating (for the last 30 days) Min 0 and max 45; lower = better outcome Participant rates 15 categories of pain type (None = 0, mild = 1, moderate = 2, severe = 3). Sum totaled for all categories
SecondaryShort Form, McGill Pain Questionnaire 2Change from Pre-Treatment Baseline to 1-Month after Series 1Pain Rating (for the last 30 days) Min 0 and max 45; lower = better outcome Participant rates 15 categories of pain type (None = 0, mild = 1, moderate = 2, severe = 3). Sum totaled for all categories
SecondaryShort Form, McGill Pain Questionnaire 3Change from 1-Week to 1-Month after Series 1Pain Rating (for the last 30 days) Min 0 and max 45; lower = better outcome Participant rates 15 categories of pain type (None = 0, mild = 1, moderate = 2, severe = 3). Sum totaled for all categories
SecondaryShort Form, McGill Pain Questionnaire 4Change from Pre-Treatment Baseline to 1-Week after Series 2Pain Rating (for the last 30 days) Min 0 and max 45; lower = better outcome Participant rates 15 categories of pain type (None = 0, mild = 1, moderate = 2, severe = 3). Sum totaled for all categories
SecondaryPittsburgh Sleep Quality Index (PSQI) 1Change from Pre-Treatment Baseline to 1-Week after Series 1
9 item questionnaire- made up of 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction) Min of 0 and max of 3 per component. Global Sleep Score is total of 7 components Min score of 0 and max score of 21; lower score = better outcome
SecondaryPittsburgh Sleep Quality Index (PSQI) 2Change from Pre-Treatment Baseline to 1-Month after Series 1
9 item questionnaire- made up of 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction) Min of 0 and max of 3 per component. Global Sleep Score is total of 7 components Min score of 0 and max score of 21; lower score = better outcome
SecondaryPittsburgh Sleep Quality Index (PSQI) 3Change from 1-Week to 1-Month after Series
9 item questionnaire- made up of 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction) Min of 0 and max of 3 per component. Global Sleep Score is total of 7 components Min score of 0 and max score of 21; lower score = better outcome
SecondaryPittsburgh Sleep Quality Index (PSQI) 4Change from Pre-Treatment Baseline to 1-Week after Series 2
9 item questionnaire- made up of 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction) Min of 0 and max of 3 per component. Global Sleep Score is total of 7 components Min score of 0 and max score of 21; lower score = better outcome
SecondaryQuality of Community Integration Questionnaire Total CIQ Score 1Change from Pre-Treatment Baseline to 1-Week after Series 1
CIQ Cognitive Integration Score: 22 Questions Higher Score = better outcome Participant self-report of Current Level of Functional independence and satisfaction level of that ability on various cognitive and social/work/family interactions. Score 0-2 points for each item Composite Score: Sum of Home Integration 5 items, Social Integration 6 items and Productivity Scores 2 items; Range 0-29
SecondaryQuality of Community Integration Questionnaire Total CIQ Score 2Change from Pre-Treatment Baseline to 1-Month after Series 1
CIQ Cognitive Integration Score: 22 Questions Higher Score = better outcome Participant self-report of Current Level of Functional independence and satisfaction level of that ability on various cognitive and social/work/family interactions. Score 0-2 points for each item Composite Score: Sum of Home Integration 5 items, Social Integration 6 items and Productivity Scores 2 items; Range 0-29
SecondaryQuality of Community Integration Questionnaire Total CIQ Score 3Change from 1-Week to 1-Month after Series
CIQ Cognitive Integration Score: 22 Questions Higher Score = better outcome Participant self-report of Current Level of Functional independence and satisfaction level of that ability on various cognitive and social/work/family interactions. Score 0-2 points for each item Composite Score: Sum of Home Integration 5 items, Social Integration 6 items and Productivity Scores 2 items; Range 0-29
SecondaryQuality of Community Integration Questionnaire Total CIQ Score 4Change from Pre-Treatment Baseline to 1-Week after Series 2
CIQ Cognitive Integration Score: 22 Questions Higher Score = better outcome Participant self-report of Current Level of Functional independence and satisfaction level of that ability on various cognitive and social/work/family interactions. Score 0-2 points for each item Composite Score: Sum of Home Integration 5 items, Social Integration 6 items and Productivity Scores 2 items; Range 0-29
SecondaryQuality of Community Integration Questionnaire (QCIQ) Score 1Change from Pre-Treatment Baseline to 1-Week after Series 1
Quality of Community Integration (QCIQ) Score (Patient Satisfaction Level) 0-4 for satisfaction level on each item Range: 9 - 36 (Self-Report of satisfaction of home and social integration and productivity Higher Score = better outcome
SecondaryQuality of Community Integration Questionnaire (QCIQ) Score 2Change from Pre-Treatment Baseline to 1-Month after Series 1
Quality of Community Integration (QCIQ) Score (Patient Satisfaction Level) 0-4 for satisfaction level on each item Range: 9 - 36 (Self-Report of satisfaction of home and social integration and productivity Higher Score = better outcome
SecondaryQuality of Community Integration Questionnaire (QCIQ) Score 3Change from 1-Week to 1-Month after Series
Quality of Community Integration (QCIQ) Score (Patient Satisfaction Level) 0-4 for satisfaction level on each item Range: 9 - 36 (Self-Report of satisfaction of home and social integration and productivity Higher Score = better outcome
SecondaryQuality of Community Integration Questionnaire (QCIQ) Score 4Change from Pre-Treatment Baseline to 1-Week after Series 2
Quality of Community Integration (QCIQ) Score (Patient Satisfaction Level) 0-4 for satisfaction level on each item Range: 9 - 36 (Self-Report of satisfaction of home and social integration and productivity Higher Score = better outcome
SecondaryQuality of Community Integration Questionnaire Cognitive Satisfaction Score 1Change from Pre-Treatment Baseline to 1-Week after Series 1Cognitive Satisfaction Score: Sum of 6 items related to cognitive satisfaction Range 6 - 24
SecondaryQuality of Community Integration Questionnaire Cognitive Satisfaction Score 2Change from Pre-Treatment Baseline to 1-Month after Series 1Cognitive Satisfaction Score: Sum of 6 items related to cognitive satisfaction Range 6 - 24
SecondaryQuality of Community Integration Questionnaire Cognitive Satisfaction Score 3Change from 1-Week to 1-Month after SeriesCognitive Satisfaction Score: Sum of 6 items related to cognitive satisfaction Range 6 - 24
SecondaryQuality of Community Integration Questionnaire Cognitive Satisfaction Score 4Change from Pre-Treatment Baseline to 1-Week after Series 2Cognitive Satisfaction Score: Sum of 6 items related to cognitive satisfaction Range 6 - 24

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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