Trial Outcomes & Findings for Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint (NCT NCT03232749)

Results Overview

ASES (American Shoulder \& Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months

Results posted on

2021-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Symptomatic Primary Osteoarthritis of the Shoulder Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder Ultrasound: ultrasound-guided IACSI
Overall Study STARTED	25
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Symptomatic Primary Osteoarthritis of the Shoulder n=25 Participants Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder Ultrasound: ultrasound-guided IACSI
Age, Categorical <=18 years	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=25 Participants
Age, Categorical >=65 years	17 Participants n=25 Participants
Sex: Female, Male Female	11 Participants n=25 Participants
Sex: Female, Male Male	14 Participants n=25 Participants
Region of Enrollment United States	25 participants n=25 Participants

PRIMARY outcome

Timeframe: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months

Population: All participants did not return for all outcome measure time points

ASES (American Shoulder \& Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better).

Outcome measures

Outcome measures
Measure	Symptomatic Primary Osteoarthritis of the Shoulder n=25 Participants Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder Ultrasound: ultrasound-guided IACSI
ASES Scores at Each Time Point Baseline ASES score	48.52 score on a scale Standard Deviation 13.18
ASES Scores at Each Time Point 2 Week ASES score	79.72 score on a scale Standard Deviation 23.32
ASES Scores at Each Time Point 1 Month ASES scrore	73.86 score on a scale Standard Deviation 28.24
ASES Scores at Each Time Point 2 Month ASES score	28.60 score on a scale Standard Deviation 28.57
ASES Scores at Each Time Point 3 Month ASES score	71.78 score on a scale Standard Deviation 22.34
ASES Scores at Each Time Point 6 Month ASES score	61.48 score on a scale Standard Deviation 25.78

PRIMARY outcome

Timeframe: Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months

Population: All participants did not return for all outcome measure time points

VAS (Visual Analog Scale) pain score improvement \> 1.4 points (The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0=no pain and 10=worst pain). The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0=no pain and 10=worst pain.

Outcome measures

Outcome measures
Measure	Symptomatic Primary Osteoarthritis of the Shoulder n=25 Participants Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder Ultrasound: ultrasound-guided IACSI
Visual Analog Scale Scores at Each Time Point. Post-injection VAS score	1.86 score on a scale Standard Deviation 1.80
Visual Analog Scale Scores at Each Time Point. Baseline VAS score	4.54 score on a scale Standard Deviation 2.62
Visual Analog Scale Scores at Each Time Point. 2 Weeks VAS score	1.18 score on a scale Standard Deviation 1.59
Visual Analog Scale Scores at Each Time Point. 1 Month VAS score	2.05 score on a scale Standard Deviation 2.06
Visual Analog Scale Scores at Each Time Point. 2 Month VAS score	2.56 score on a scale Standard Deviation 2.97
Visual Analog Scale Scores at Each Time Point. 3 Month VAS score	2.50 score on a scale Standard Deviation 2.38
Visual Analog Scale Scores at Each Time Point. 6 Month VAS score	2.44 score on a scale Standard Deviation 3.05

PRIMARY outcome

Timeframe: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months

Population: All participants did not return for all outcome measure time points

SST (Simple Shoulder Test) score improvement \> 2.4 points. 12 items that are answered yes/no (measures functional limitations of the affected shoulder): Scored: 0-12 (Higher score is better)

Outcome measures

Outcome measures
Measure	Symptomatic Primary Osteoarthritis of the Shoulder n=25 Participants Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder Ultrasound: ultrasound-guided IACSI
SST (Simple Shoulder Test) Scores at Each Time Point 1 Month SST Score	7.32 score on a scale Standard Deviation 3.82
SST (Simple Shoulder Test) Scores at Each Time Point 2 Month SST Score	5.92 score on a scale Standard Deviation 3.43
SST (Simple Shoulder Test) Scores at Each Time Point 3 Month SST Score	6.73 score on a scale Standard Deviation 3.32
SST (Simple Shoulder Test) Scores at Each Time Point Baseline SST Score	5.29 score on a scale Standard Deviation 2.46
SST (Simple Shoulder Test) Scores at Each Time Point 2 Week SST Score	8.40 score on a scale Standard Deviation 2.36
SST (Simple Shoulder Test) Scores at Each Time Point 6 Month SST Score	7.00 score on a scale Standard Deviation 2.73

Adverse Events

Symptomatic Primary Osteoarthritis of the Shoulder

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

MaryBeth Horodyski, Ed.D., ATC, LAT, FNATA

University of Florida

Phone: 352-273-7074

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place