Trial · NCT01483963
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Day 92 in Active Forward Flexion | Baseline, Day 92 | Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder |
| Secondary | Change From Baseline to Day 92 in Passive Forward Flexion | Baseline, Day 92 | Passive range of motion (PROM) measurement using a goniometer to assess forward flexion in the affected shoulder |
| Secondary | Change From Baseline to Day 92 in Active Abduction | Baseline, Day 92 | AROM measurement using a goniometer to assess abduction in the affected shoulder |
| Secondary | Change From Baseline to Day 92 in Passive Abduction | Baseline, Day 92 | PROM measurement using a goniometer to assess abduction in the affected shoulder |
| Secondary | Change From Baseline to Day 92 in Active External Rotation | Baseline, Day 92 | AROM measurement using a goniometer to assess external rotation in the affected shoulder |
| Secondary | Change From Baseline to Day 92 in Passive External Rotation | Baseline, Day 92 | PROM measurement using a goniometer to assess external rotation in the affected shoulder |
| Secondary | Change From Baseline to Day 92 in Active Internal Rotation | Baseline, Day 92 | AROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder |
| Secondary | Change From Baseline to Day 92 in Passive Internal Rotation | Baseline, Day 92 | PROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder |
| Secondary | Change From Baseline to Day 92 in American Shoulder and Elbow Surgeons (ASES) Composite Score | Baseline, Day 92 | Composite score ranging from 0-100, with 0 being worst pain and function loss, derived from the sum of the scores from pain subscale (11-point NRS where 0=no pain at all and 10=pain) and function subscale (activity questionnaire where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation |
| Secondary | Change From Baseline to Day 92 in ASES Pain Subscale | Baseline, Day 92 | Pain subscale score ranging from 0-50, with 0 being greatest pain, derived from participant assessment of pain in response to "How bad is the pain in your affected shoulder today?" on an 11-point numerical rating scale (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 |
| Secondary | Change From Baseline to Day 92 in ASES Function Subscale | Baseline, Day 92 | 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 |
| Secondary | Subject Satisfaction With Treatment at Day 92 | Day 92 | Participant assessment of satisfaction with treatment rated as very satisfied, quite satisfied, neither satisfied nor dissatisfied, quite dissatisfied, or very dissatisfied. |
| Secondary | Investigator Assessment of Improvement With Treatment at Day 92 | Day 92 | 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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GET https://conductscience.org/api/trials/v1/NCT01483963/registered