Trial Outcomes & Findings for Glenohumeral Cortisone Injection (NCT NCT04216017)

NCT ID: NCT04216017

Last Updated: 2023-09-26

Results Overview

Outcome Instrument high is good low is bad 0-100 The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2023-09-26

Participant Flow

Participant milestones

Measure	Controls Patients receiving lidocaine Lidocaine: Lidocaine injection into shoulder	Cases Patients receiving Kenalog kenalog: Cortisone injection into shoulder
Overall Study STARTED	5	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Glenohumeral Cortisone Injection

Baseline characteristics by cohort

Measure	Controls n=5 Participants Patients receiving lidocaine Lidocaine: Lidocaine injection into shoulder	Cases n=4 Participants Patients receiving Kenalog kenalog: Cortisone injection into shoulder	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
ASES	43.4 units on a scale STANDARD_DEVIATION 19.3 • n=5 Participants	51.3 units on a scale STANDARD_DEVIATION 5.4 • n=7 Participants	46.9 units on a scale STANDARD_DEVIATION 14.9 • n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome Instrument high is good low is bad 0-100 The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder.

Outcome measures

Measure	Controls n=4 Participants Patients receiving lidocaine Lidocaine: Lidocaine injection into shoulder	Cases n=4 Participants Patients receiving Kenalog kenalog: Cortisone injection into shoulder
American Shoulder Elbow Society Score	46 score on a scale Standard Deviation 20	87 score on a scale Standard Deviation 8

SECONDARY outcome

Timeframe: 24 weeks

Population: Population at 24 weeks

pain scale - high is bad - low is good 0-100

Outcome measures

Measure	Controls n=4 Participants Patients receiving lidocaine Lidocaine: Lidocaine injection into shoulder	Cases n=4 Participants Patients receiving Kenalog kenalog: Cortisone injection into shoulder
Visual Analogue Scale	4 units on a scale Standard Deviation 3.7	1 units on a scale Standard Deviation 0.8

Adverse Events

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cases

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

Dr. Jonah Hebert-Davies

University of Washington

Phone: 2067443466

Email: jdavies2@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place