Trial Outcomes & Findings for Osteoarthritis Shoulder Injection Study (NCT NCT03586687)

NCT ID: NCT03586687

Last Updated: 2022-03-02

Results Overview

The Shoulder Pain and Disability Index (SPADI) measures current shoulder pain and disability using a 13 item assessment. Scores range from 0-100 with higher scores indicating greater impairment or disability

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 19 participants
• Primary outcome timeframe: baseline, 2, 4, and 6 months. Baseline SPADI score was collected prior to injection.
• Results posted on: 2022-03-02

Participant Flow

Participant milestones

Measure	20 mg Triamcinolone With 3cc of 1% Lidocaine 20mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	40 mg Triamcinolone With 3cc of 1% Lidocaine 40mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	80 mg Triamcinolone With 3cc of 1% Lidocaine 80mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection
Overall Study NOT COMPLETED	0	0	0
Overall Study STARTED	6	9	4
Overall Study COMPLETED	6	9	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	20 mg n=6 Participants 20mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	40 mg n=9 Participants 40mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	80 mg n=4 Participants 80mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	Total n=19 Participants Total of all reporting groups
Age, Continuous	63.67 years STANDARD_DEVIATION 12.26 • n=6 Participants	69.33 years STANDARD_DEVIATION 6.93 • n=9 Participants	64.50 years STANDARD_DEVIATION 12.29 • n=4 Participants	66.53 years STANDARD_DEVIATION 9.79 • n=19 Participants
Sex: Female, Male Female	2 Participants n=6 Participants	4 Participants n=9 Participants	3 Participants n=4 Participants	9 Participants n=19 Participants
Sex: Female, Male Male	4 Participants n=6 Participants	5 Participants n=9 Participants	1 Participants n=4 Participants	10 Participants n=19 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: baseline, 2, 4, and 6 months. Baseline SPADI score was collected prior to injection.

Population: Difference in subjects analyzed for all arms was due to the need of subsequent treatment

The Shoulder Pain and Disability Index (SPADI) measures current shoulder pain and disability using a 13 item assessment. Scores range from 0-100 with higher scores indicating greater impairment or disability

Outcome measures

Measure	20 mg Triamcinolone With 3cc of 1% Lidocaine n=6 Participants 20mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	40 mg Triamcinolone With 3cc of 1% Lidocaine n=9 Participants 40mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	80 mg Triamcinolone With 3cc of 1% Lidocaine n=4 Participants 80mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection
Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. Baseline SPADI Score	58.17 score on a scale Standard Deviation 17.88	60.67 score on a scale Standard Deviation 17.91	44.50 score on a scale Standard Deviation 18.34
Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. 2 month SPADI Score	30.60 score on a scale Standard Deviation 22.60	48.67 score on a scale Standard Deviation 22.01	22.25 score on a scale Standard Deviation 19.97
Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. 4 month SPADI Score	44.80 score on a scale Standard Deviation 30.11	51.12 score on a scale Standard Deviation 27.53	35.67 score on a scale Standard Deviation 34.43
Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. 6 month SPADI Score	44.60 score on a scale Standard Deviation 25.60	57.71 score on a scale Standard Deviation 18.62	26.00 score on a scale Standard Deviation 7.07

PRIMARY outcome

Timeframe: baseline, 2, 4, and 6 months. Baseline data was collected at 2wks post injection phone call.

Adverse events will only include those that are determined to be related to steroid Adverse Reactions to the Steroid are reported as combined for all the participants and not at the per-participant level.

Outcome measures

Measure	20 mg Triamcinolone With 3cc of 1% Lidocaine n=6 Participants 20mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	40 mg Triamcinolone With 3cc of 1% Lidocaine n=9 Participants 40mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	80 mg Triamcinolone With 3cc of 1% Lidocaine n=4 Participants 80mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection
Assess Reactions to the Steroid Baseline	1 Reactions	2 Reactions	0 Reactions
Assess Reactions to the Steroid 2 month follow up	0 Reactions	0 Reactions	0 Reactions
Assess Reactions to the Steroid 4 month follow up	0 Reactions	0 Reactions	0 Reactions
Assess Reactions to the Steroid 6 month follow up	0 Reactions	0 Reactions	0 Reactions

SECONDARY outcome

Timeframe: 12 months

Shoulder arthroplasty is defined as total shoulder replacement

Outcome measures

Measure	20 mg Triamcinolone With 3cc of 1% Lidocaine n=6 Participants 20mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	40 mg Triamcinolone With 3cc of 1% Lidocaine n=9 Participants 40mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	80 mg Triamcinolone With 3cc of 1% Lidocaine n=4 Participants 80mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection
Rate of Shoulder Arthroplasty Following Injection	3 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Subjects who underwent shoulder arthroplasty by/at 12 months

The Shoulder Pain and Disability Index (SPADI) measures current shoulder pain and disability using a 13 item assessment. Scores range from 0-100 with higher scores indicating greater impairment or disability

Outcome measures

Measure	20 mg Triamcinolone With 3cc of 1% Lidocaine n=1 Participants 20mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	40 mg Triamcinolone With 3cc of 1% Lidocaine n=1 Participants 40mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	80 mg Triamcinolone With 3cc of 1% Lidocaine n=1 Participants 80mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection
Change in Overall SPADI Scores for Those Receiving Shoulder Arthroplasty at 1 Year	2 score on a scale Standard Deviation NA Standard Deviation is not calculable for 1 participant	12 score on a scale Standard Deviation NA Standard Deviation is not calculable for 1 participant	4 score on a scale Standard Deviation NA Standard Deviation is not calculable for 1 participant

Adverse Events

20 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

40 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

80 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	20 mg n=6 participants at risk 20mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	40 mg n=9 participants at risk 40mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	80 mg n=4 participants at risk 80mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection
General disorders Steroid flare	0.00% 0/6 • Adverse events were collected for 6 months	11.1% 1/9 • Number of events 1 • Adverse events were collected for 6 months	0.00% 0/4 • Adverse events were collected for 6 months
Nervous system disorders Headaches	0.00% 0/6 • Adverse events were collected for 6 months	11.1% 1/9 • Number of events 1 • Adverse events were collected for 6 months	0.00% 0/4 • Adverse events were collected for 6 months
General disorders Facial flushing	16.7% 1/6 • Number of events 1 • Adverse events were collected for 6 months	0.00% 0/9 • Adverse events were collected for 6 months	0.00% 0/4 • Adverse events were collected for 6 months

Additional Information

Cayce Onks, DO

Penn State Hershey Medical Center

Phone: 7175317127

Email: conks@pennstatehealth.psu.edu

Results disclosure agreements

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