Trial Outcomes & Findings for Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections (NCT NCT02591953)
NCT ID: NCT02591953
Last Updated: 2022-07-18
Results Overview
12 question assessment of shoulder function with yes or no answers
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
1 year
Results posted on
2022-07-18
Participant Flow
Participant milestones
| Measure |
Ultrasound-guided Injection
Injection performed with ultrasound-guidance
Ultrasound-guidance: Using ultrasound-guidance to perform a corticosteroid injection
Methylprednisolone: Corticosteroid used in injection (40 mg)
Lidocaine 1%: Anesthesic used in injection
|
Landmark-guided Injection
Injection performed at point of maximal tenderness along biceps tendon
Landmark-guidance: Using landmark-guidance to perform a corticosteroid injection
Methylprednisolone: Corticosteroid used in injection (40 mg)
Lidocaine 1%: Anesthesic used in injection
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Ultrasound-guided Injection
Injection performed with ultrasound-guidance
Ultrasound-guidance: Using ultrasound-guidance to perform a corticosteroid injection
Methylprednisolone: Corticosteroid used in injection (40 mg)
Lidocaine 1%: Anesthesic used in injection
|
Landmark-guided Injection
Injection performed at point of maximal tenderness along biceps tendon
Landmark-guidance: Using landmark-guidance to perform a corticosteroid injection
Methylprednisolone: Corticosteroid used in injection (40 mg)
Lidocaine 1%: Anesthesic used in injection
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ultrasound-guided Injection
n=12 Participants
Injection performed with ultrasound-guidance
Ultrasound-guidance: Using ultrasound-guidance to perform a corticosteroid injection
Methylprednisolone: Corticosteroid used in injection (40 mg)
Lidocaine 1%: Anesthesic used in injection
|
Landmark-guided Injection
n=10 Participants
Injection performed at point of maximal tenderness along biceps tendon
Landmark-guidance: Using landmark-guidance to perform a corticosteroid injection
Methylprednisolone: Corticosteroid used in injection (40 mg)
Lidocaine 1%: Anesthesic used in injection
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=22 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=12 Participants
|
10 Participants
n=10 Participants
|
22 Participants
n=22 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=22 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=12 Participants
|
3 Participants
n=10 Participants
|
7 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=12 Participants
|
7 Participants
n=10 Participants
|
15 Participants
n=22 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
10 participants
n=10 Participants
|
22 participants
n=22 Participants
|
|
Pain and Function Scores
|
NA units on a scale
STANDARD_DEVIATION NA • n=12 Participants
|
NA units on a scale
STANDARD_DEVIATION NA • n=10 Participants
|
NA units on a scale
STANDARD_DEVIATION NA • n=22 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The study was terminated and data could not be analyzed as the department switched PRO companies. Access to the data was lost at that time.
12 question assessment of shoulder function with yes or no answers
Outcome measures
Outcome data not reported
Adverse Events
Ultrasound-guided Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Landmark-guided Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place