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Trial · NCT06359665

Registered outcomes33

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

ListOutcomeTime frameDescription
PrimaryChange from Baseline in Pain on the Visual Analog Pain (VAS) ScoreBaseline and Week 4, Week 6
The Visual Analog Pain (VAS) Score is a validated, self-reported subjective measure for measuring acute and chronic pain. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change = (Week (4 or 6) Score - Baseline Score).a validated, self-report
PrimaryChange from Baseline in Pain on the Visual Analog Pain (VAS) Score - crossover conditionBaseline and Week 10, Week 12
The Visual Analog Pain (VAS) Score is a validated, self-reported subjective measure for measuring acute and chronic pain. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change = (Week Change = (Week (10 or 12) Score - Baseline Score).
SecondaryChange from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) ScoreBaseline and Week 4, Week 6
The SANE Score is a self-reported subjective measure for measuring percentage of normal function. Possible scores range from 0 (most abnormal) to 100 (normal). Change = (Week (4 or 6) Score - Baseline Score)
SecondaryChange from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - crossover conditionBaseline and Week 10, Week 12
The SANE Score is a self-reported subjective measure for measuring percentage of normal function. Possible scores range from 0 (most abnormal) to 100 (normal). Change = (Week 10, Week 12 Score - Baseline Score)
SecondaryChange from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 ScoreBaseline and Week 4, Week 6
The PROMIS Global Health-10 is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (most severe impairment) to 20 (best health). Change = (Week (4 or 6) Score - Baseline Score)
SecondaryChange from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score - crossover conditionBaseline and Week 10, Week 12
The PROMIS Global Health-10 is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (most severe impairment) to 20 (best health). Change = (Week (10 or 12) Score - Baseline Score)
SecondaryChange from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference ScoreBaseline and Week 4, Week 6
The PROMIS Pain Interference is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (does not interfere) to 10 (completely interferes). Change = (Week (4, 6) Score - Baseline Score)
SecondaryChange from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score - crossover conditionBaseline and Week 10, Week 12
The PROMIS Pain Interference is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (does not interfere) to 10 (completely interferes). Change = (Week (10, 12) Score - Baseline Score)
SecondaryChange from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) ScoreBaseline and Week 4, Week 6The PROMIS UE computer adaptive test is a validated computer adaptive test to assess upper extremity functional status. Change = (Week (4, 6) Score - Baseline Score)
SecondaryChange from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) ScoreBaseline and Week 10, Week 12The PROMIS UE computer adaptive test is a validated computer adaptive test to assess upper extremity functional status. Change = (Week (10, 12) Score - Baseline Score)
SecondaryChange from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) IndexBaseline and Week 4, Week 6
The AUSCAN Index is a 15-item scale measuring pain (5 items), stiffness (1 item) and function (9 items) during the preceding 48 hours. Possible scores range from 0 (none) to 4 (extreme). Change = (Week (4, 6) Score - Baseline Score)
SecondaryChange from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) IndexBaseline and Week 10, Week 12
The AUSCAN Index is a 15-item scale measuring pain (5 items), stiffness (1 item) and function (9 items) during the preceding 48 hours. Possible scores range from 0 (none) to 4 (extreme). Change = (Week (10, 12) Score - Baseline Score)
SecondaryChange from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH).Baseline and Week 4The QuickDASH is a validated, self-reported 11-item scale measuring disability. Possible scores range from 0 (no disability) to 100 (most severe disability. Change = (Week 4 Score - Baseline Score)
SecondaryChange from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH) - crossover conditionBaseline and Week 10The QuickDASH is a validated, self-reported 11-item scale measuring disability. Possible scores range from 0 (no disability) to 100 (most severe disability. Change = (Week 10 Score - Baseline Score)
SecondaryChange from Baseline in perseverance on the Brief Resilience Index (BRI)Baseline and Week 4, Week 6
The BRI is a validated, self-reported 6-item validated tool to assess for resilience. Possible scores range from 1 (low resilience) to 5 (high resilience). Change = (Week (4, 6) Score - Baseline Score)
SecondaryChange from Baseline in perseverance on the Brief Resilience Index (BRI) - crossover conditionBaseline and Week 10, Week 12
The BRI is a validated, self-reported 6-item validated tool to assess for resilience. Possible scores range from 1 (low resilience) to 5 (high resilience). Change = (Week (10, 12) Score - Baseline Score)
SecondaryNumber of Participants With Treatment-Related Adverse EventsThrough study completion, an average of 12 weeksTreatment-related adverse events will be reported throughout the study by self-report and clinician-driven questions at each visit
SecondaryChange from Baseline in the Mean Seated Trough Cuff Systolic Blood PressureBaseline and Week 4Blood pressure (SBP and DBP) in mmHg using Sphygmomanometer will be assessed by the researchers at baseline and follow-up
SecondaryChange from Baseline in heart rateBaseline and Week 4Heartbeats per minute (BPM) will be assessed by the researchers at baseline and follow-up
SecondaryChange from Baseline in the Mean Seated Trough Cuff Systolic Blood PressureWeek 4 and Week 6Blood pressure (SBP and DBP) in mmHg using Sphygmomanometer will be assessed by the researchers at baseline and follow-up

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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