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Trial · NCT02006719

Registered outcomes13

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

ListOutcomeTime frameDescription
PrimaryChange From Baseline to Day 95 in Active Forward FlexionBaseline, day 95Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder
SecondaryChange From Baseline to Day 95 in Adapted American Shoulder and Elbow Surgeons (ASES) Function SubscaleBaseline, day 95
Function subscale score ranging from 0-50, with 0 being most dysfunctional, derived from participant assessment of ability to do 10 activities with affected shoulder/arm where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult, and calculated as (cumulative total score for the 10 activity items) × (5/3); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation (United States adapted version).
SecondaryChange From Baseline to Day 95 in Pain With Movement Using 11-point Numeric Rating Scale (NRS)Baseline, day 95
Participant assessment of pain in response to "How bad is the pain upon movement of your affected shoulder at its worst in the last 24 hours?" using an 11-point NRS where 0=no pain at all and 10=pain as bad as it can be.
SecondaryChange From Baseline to Day 95 in Active AbductionBaseline, day 95AROM measurement using a goniometer to assess abduction in the affected shoulder
SecondaryChange From Baseline to Day 95 in Passive Forward FlexionBaseline, day 95Passive range of motion (PROM) measurement using a goniometer to assess forward flexion in the affected shoulder
SecondaryChange From Baseline to Day 95 in Passive AbductionBaseline, day 95PROM measurement using a goniometer to assess abduction in the affected shoulder
SecondaryChange From Baseline to Day 95 in Active Internal RotationBaseline, day 95AROM measurement using a goniometer to assess internal rotation in the affected shoulder
SecondaryChange From Baseline to Day 95 in Active External RotationBaseline, day 95AROM measurement using a goniometer to assess external rotation in the affected shoulder
SecondaryChange From Baseline to Day 95 in Passive Internal RotationBaseline, day 95PROM measurement using a goniometer to assess internal rotation in the affected shoulder
SecondaryChange From Baseline to Day 95 in Passive External RotationBaseline, day 95PROM measurement using a goniometer to assess external rotation in the affected shoulder
SecondaryChange From Baseline to Day 95 in Adapted ASES Pain SubscaleBaseline, day 95
Pain subscale score ranging from 0-50, with 0 being greatest pain, derived from participant overall assessment of pain in response to "How bad is the pain in your affected shoulder today?" using an 11-point NRS where 0=no pain at all and 10=pain as bad as it can be and calculated as (10 - NRS score) x 5; adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation
SecondarySubject Satisfaction With Treatment at Day 95Day 95Participant assessment of satisfaction with treatment rated as very satisfied, quite satisfied, neither satisfied nor dissatisfied, quite dissatisfied, or very dissatisfied.
SecondaryInvestigator Assessment of Improvement With Treatment at Day 95Day 95
Investigator assessment of degree of improvement in severity of the participant's treated shoulder compared with screening rated as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much 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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