Trial Outcomes & Findings for Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions (NCT NCT04278833)
NCT ID: NCT04278833
Last Updated: 2025-02-12
Results Overview
Mean change in pain averaged over last 7 days compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
165 participants
Primary outcome timeframe
Baseline and at 2 weeks, 3 months, and 6 months post intervention
Results posted on
2025-02-12
Participant Flow
165 participants signed informed consent, 96 were allocated to treatment
Participant milestones
| Measure |
Particulate Corticosteroid Injection - Shoulder Injection Site
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Particulate Corticosteroid Injection - Hip Injection Site
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Shoulder Injection Site
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Hip Injection Site
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
13
|
41
|
9
|
|
Overall Study
COMPLETED
|
33
|
13
|
41
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions
Baseline characteristics by cohort
| Measure |
Particulate Corticosteroid Injection - Shoulder Injection Site
n=33 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Particulate Corticosteroid Injection - Hip Injection Site
n=13 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Shoulder Injection Site
n=41 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Hip Injection Site
n=9 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 15.9 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
67.5 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
58.7 years
STANDARD_DEVIATION 12.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and at 2 weeks, 3 months, and 6 months post interventionMean change in pain averaged over last 7 days compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes.
Outcome measures
| Measure |
Particulate Corticosteroid Injection - Shoulder Injection Site
n=33 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Particulate Corticosteroid Injection - Hip Injection Site
n=13 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Shoulder Injection Site
n=41 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Hip Injection Site
n=9 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
|---|---|---|---|---|
|
Mean Change in Average Pain From Baseline
6 months
|
-1.6 score on a scale
Standard Deviation 2.7
|
-0.9 score on a scale
Standard Deviation 3.1
|
-2.1 score on a scale
Standard Deviation 2.7
|
-0.5 score on a scale
Standard Deviation 0.7
|
|
Mean Change in Average Pain From Baseline
Baseline
|
6.0 score on a scale
Standard Deviation 2.1
|
5.1 score on a scale
Standard Deviation 3.1
|
5.9 score on a scale
Standard Deviation 2.2
|
5.0 score on a scale
Standard Deviation 3.3
|
|
Mean Change in Average Pain From Baseline
2 weeks
|
-2.9 score on a scale
Standard Deviation 2.0
|
-2.0 score on a scale
Standard Deviation 2.5
|
-1.5 score on a scale
Standard Deviation 2.0
|
-1.8 score on a scale
Standard Deviation 2.3
|
|
Mean Change in Average Pain From Baseline
3 months
|
-1.8 score on a scale
Standard Deviation 2.6
|
-1.8 score on a scale
Standard Deviation 3.3
|
-2.2 score on a scale
Standard Deviation 2.3
|
0.5 score on a scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Baseline and at 2 weeks, 3 months, and 6 months post interventionDecrease in pain compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes.
Outcome measures
| Measure |
Particulate Corticosteroid Injection - Shoulder Injection Site
n=33 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Particulate Corticosteroid Injection - Hip Injection Site
n=13 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Shoulder Injection Site
n=41 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Hip Injection Site
n=9 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
|---|---|---|---|---|
|
Number of Participants With ≥50% Decrease in Pain From Baseline
2 weeks
|
4 Participants
|
3 Participants
|
13 Participants
|
3 Participants
|
|
Number of Participants With ≥50% Decrease in Pain From Baseline
3 months
|
6 Participants
|
3 Participants
|
18 Participants
|
0 Participants
|
|
Number of Participants With ≥50% Decrease in Pain From Baseline
6 months
|
8 Participants
|
2 Participants
|
13 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and at 2 weeks, 3 months, and 6 months post interventionPopulation: Data collected for participants with hip injections only.
The WOMAC questionnaire will be used for participants who underwent hip injection. The outcome of interest is the mean change in score compared to baseline. The WOMAC is a 24 item scale with scores ranging from 0 to 96, with higher scores indicating worse outcomes.
Outcome measures
| Measure |
Particulate Corticosteroid Injection - Shoulder Injection Site
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Particulate Corticosteroid Injection - Hip Injection Site
n=13 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Shoulder Injection Site
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Hip Injection Site
n=9 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
|---|---|---|---|---|
|
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Baseline
|
—
|
64.3 score on a scale
Standard Deviation 24.8
|
—
|
62.3 score on a scale
Standard Deviation 15.5
|
|
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Change at 2 weeks
|
—
|
-18.6 score on a scale
Standard Deviation 15.3
|
—
|
-10.3 score on a scale
Standard Deviation 12.1
|
|
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Change at 3 months
|
—
|
-14.4 score on a scale
Standard Deviation 16.8
|
—
|
-4.0 score on a scale
Standard Deviation 10.1
|
|
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Change at 6 months
|
—
|
-14.1 score on a scale
Standard Deviation 15.1
|
—
|
-1.0 score on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: Baseline and at 2 weeks, 3 months, and 6 months post interventionPopulation: Data collected for participants for shoulder injections only.
The QDASH questionnaire will be used for participants who underwent glenohumeral joint, subdeltoid bursa, or peritendinous biceps injection. The outcome of interest is the mean change in score compared to baseline. The QDASH is an 11 item scale with scores ranging from 0 to 100, with higher scores indicating worse outcomes.
Outcome measures
| Measure |
Particulate Corticosteroid Injection - Shoulder Injection Site
n=33 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Particulate Corticosteroid Injection - Hip Injection Site
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Shoulder Injection Site
n=41 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Hip Injection Site
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
|---|---|---|---|---|
|
Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH)
Change at 6 months
|
-15.5 score on a scale
Standard Deviation 16.4
|
—
|
-21.0 score on a scale
Standard Deviation 21.5
|
—
|
|
Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH)
Baseline
|
41.9 score on a scale
Standard Deviation 22.8
|
—
|
49.0 score on a scale
Standard Deviation 21.8
|
—
|
|
Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH)
Change at 2 weeks
|
-15.7 score on a scale
Standard Deviation 12.2
|
—
|
-11.4 score on a scale
Standard Deviation 13.2
|
—
|
|
Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH)
Change at 3 months
|
-9.1 score on a scale
Standard Deviation 12.3
|
—
|
-17.1 score on a scale
Standard Deviation 16.6
|
—
|
SECONDARY outcome
Timeframe: Baseline and at 2 weeks, 3 months, and 6 months post interventionPopulation: Data collected for participants for shoulder injections only.
The ASES questionnaire will be used for participants who underwent glenohumeral joint, subdeltoid bursa, or peritendinous biceps injection. The outcome of interest is the mean change in score compared to baseline. The ASES is an 11 item scale with scores ranging from 0 to 100, with higher scores indicating better outcomes.
Outcome measures
| Measure |
Particulate Corticosteroid Injection - Shoulder Injection Site
n=33 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Particulate Corticosteroid Injection - Hip Injection Site
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Shoulder Injection Site
n=41 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Hip Injection Site
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
|---|---|---|---|---|
|
Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form
Baseline
|
62.9 score on a scale
Standard Deviation 19.7
|
—
|
61.5 score on a scale
Standard Deviation 19.2
|
—
|
|
Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form
Change at 2 weeks
|
18.0 score on a scale
Standard Deviation 12.7
|
—
|
12.8 score on a scale
Standard Deviation 14.5
|
—
|
|
Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form
Change at 3 months
|
14.1 score on a scale
Standard Deviation 18.1
|
—
|
20.3 score on a scale
Standard Deviation 20.8
|
—
|
|
Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form
Change at 6 months
|
18.1 score on a scale
Standard Deviation 22.1
|
—
|
23.9 score on a scale
Standard Deviation 26.2
|
—
|
SECONDARY outcome
Timeframe: 6 months post initial interventionPopulation: Participants with available data.
Total number of corticosteroid injections to the specific anatomical site during the study period. The study protocol allows for a maximum of 3 injections during the 6 month study period based on the treating physician's discretion.
Outcome measures
| Measure |
Particulate Corticosteroid Injection - Shoulder Injection Site
n=33 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Particulate Corticosteroid Injection - Hip Injection Site
n=11 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Shoulder Injection Site
n=41 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Hip Injection Site
n=8 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
|---|---|---|---|---|
|
Number of Participants With Repeat Corticosteroid Injections
|
6 participants
|
2 participants
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 months post initial interventionNumber (%) of participants who were referred for surgical intervention on the specific anatomical site during the study follow up period.
Outcome measures
| Measure |
Particulate Corticosteroid Injection - Shoulder Injection Site
n=33 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Particulate Corticosteroid Injection - Hip Injection Site
n=13 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Shoulder Injection Site
n=41 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
Non-particulate Corticosteroid Injection - Hip Injection Site
n=9 Participants
Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
|
|---|---|---|---|---|
|
Number of Participants Referred for Surgical Intervention (Conversion to Surgery)
|
6 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
Particulate Corticosteroid Injection - Shoulder Injection Site
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Particulate Corticosteroid Injection - Hip Injection Site
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-particulate Corticosteroid Injection - Shoulder Injection Site
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-particulate Corticosteroid Injection - Hip Injection Site
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