Trial · NCT04496167
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Adapted American Shoulder and Elbow Surgeons Shoulder Assessment Form (ASES) Composite Score for the Affected Shoulder at Day 95 | Baseline, Day 95 | Adapted ASES is a self-administered participant reported outcome measure, divided into 2 sections: pain and function. Pain subscale is a single item, 11-point numeric rating scale, ranging from 0 (no pain at all) to 10 (worst pain), calculated as 10 - pain raw score and multiplying by 5, score ranging from 0 (worst pain) to 50 (no pain). Function subscale consists of 10 activities, 4-point ordinal scale about their ability to do the activity with the affected arm, ranging from 0 (unable to do) to 3 (not difficult), calculated by multiplying total score for 10 items by 5 and then dividing it by 3, score range of 0 (no function) to 50 (full function). Adapted ASES composite score is the sum of the pain subscale score (50% of the composite score) and function subscale score (50% of the composite score), score range of 0 (worst pain) to 100 (least pain). Positive change from Baseline score means an improvement in pain and/or shoulder function. |
| Secondary | Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | PROM for forward flexion was measured using a goniometer. Positive change from Baseline means an improvement. |
| Secondary | Change From Baseline in PROM for Internal Rotation in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | PROM for internal rotation was measured using a goniometer and a spinal level. Positive change from Baseline means an improvement. |
| Secondary | Change From Baseline in PROM for External Rotation in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | PROM for external rotation was measured using a goniometer. Positive change from Baseline means an improvement. |
| Secondary | Change From Baseline in PROM for Abduction in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | PROM for abduction was measured using a goniometer. Positive change from Baseline means an improvement. |
| Secondary | Change From Baseline in PROM for Shoulder Extension in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | PROM for shoulder extension was measured using a goniometer. Positive change from Baseline means an improvement. |
| Secondary | Change From Baseline in PROM for Forward Flexion in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | PROM for forward flexion was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95. Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder Change from baseline was calculated as: (Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value |
| Secondary | Change From Baseline in PROM for Internal Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | PROM for internal rotation was measured using a goniometer and a spinal level. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95. Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder Change from baseline was calculated as: (Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value |
| Secondary | Change From Baseline in PROM for External Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | PROM for external rotation was measured using a goniometer PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95. Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder Change from baseline was calculated as: (Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value |
| Secondary | Change From Baseline in PROM for Abduction in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | PROM for abduction was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95. Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder Change from baseline was calculated as: (Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value |
| Secondary | Change From Baseline in PROM for Shoulder Extension in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | PROM for shoulder extension was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95. Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder Change from baseline was calculated as: (Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value |
| Secondary | Change From Baseline in Active Range of Motion (AROM) for Forward Flexion in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | AROM for forward flexion was measured using a goniometer. Positive change from Baseline means an improvement. |
| Secondary | Change From Baseline in AROM for Internal Rotation in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | AROM for internal rotation was measured using a goniometer and a spinal level. Positive change from Baseline means an improvement. |
| Secondary | Change From Baseline in AROM for External Rotation in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | AROM for external rotation was measured using a goniometer. Positive change from Baseline means an improvement. |
| Secondary | Change From Baseline in AROM for Abduction in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | AROM for abduction was measured using a goniometer. Positive change from Baseline means an improvement. |
| Secondary | Change From Baseline in AROM for Shoulder Extension in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | AROM for shoulder extension was measured using a goniometer. Positive change from Baseline means an improvement. |
| Secondary | Change From Baseline in AROM for Forward Flexion in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | AROM for forward flexion was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95. Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder Change from baseline was calculated as: (Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value |
| Secondary | Change From Baseline in AROM for Internal Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | AROM for internal rotation was measured using a goniometer and a spinal level. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95. Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder Change from baseline was calculated as: (Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value |
| Secondary | Change From Baseline in AROM for External Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | AROM for external rotation was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95. Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder Change from baseline was calculated as: (Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value |
| Secondary | Change From Baseline in AROM for Abduction in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | AROM for abduction was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95. Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder Change from baseline was calculated as: (Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value |
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.
For software
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