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Osteoarthritis Shoulder Injection Study

Clinical Outcomes Following Randomization of Steroid Concentration in Patients With Glenohumeral Osteoarthritis

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03586687
Enrollment
19
Registered
2018-07-13
Start date
2018-07-13
Completion date
2021-09-28
Last updated
2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glenohumeral Osteoarthritis

Keywords

Ultrasound guided injection

Brief summary

The purpose of this study is to determine the most effective intraarticular steroid dose for the treatment of glenohumeral osteoarthritis. The investigators aim to randomize patients into low, medium, and high dose groups of injectable corticosteroids as these doses are typically used in the standard of care for our patients. To date there has been no study to evaluate which dose is most efficient with the fewest side effects for glenohumeral osteoarthritis. The investigators objective will be to provide ultrasound guided intraarticular glenohumeral injections of these randomized concentrations and to evaluate pain and function before and following injection with the Shoulder Pain and Disability Index (SPADI). The investigators hypothesize that the low dose steroid will provide equivalent improvement of the pain and function to the medium and high doses, while minimizing side effects.

Detailed description

Osteoarthritis (OA) affects 54.4 million US adults and 23.7 million (43.5%) have arthritis-attributable activity limitation. As the condition progresses, pain and functional disability increase. Patients usually begin treatment with conservative measures including physical therapy and administration of nonsteroidal anti-inflammatory drugs before obtaining a corticosteroid injection. Corticosteroid injections have a patient-specific duration that often provide relief for a month before the effects begin to taper with most individuals returning to baseline by 2-3 months post injection. Unfortunately, data on intraarticular injections is not robust and primarily focused on hip, knee, and disease processes rather than the glenohumeral joint. For example, steroid concentrations have been studied in adhesive capsulitis, where 20 and 40mg of triamcinolone acenotide were used with no statistical significance between the two. When a placebo was added, both doses were better than the placebo, but once again no difference was seen between the two steroid concentrations. Another study, looking at knee osteoarthritis, found that high dose steroids had a larger effect on duration, but other studies have shown no difference in duration between the 40mg and 80mg concentration of triamcinolone acetonide. Intraarticular injections do have adverse effects. Similar to steroids taken orally or intravenously, intraarticular injections have a similar side effect profile. Fortunately, intraarticular injections are localized, by the nature of the procedure, and the chances of experiencing a significant side effect is rare. The most common side effects are steroid flare, allergic reaction, facial erythema, hypo-pigmentation, fat pad necrosis, cutaneous atrophy, and a transient increase in blood glucose. Some of the rare side effects have been seen in case reports include idiopathic central serous chorioretinopathy, decrease in breast milk production, sepsis, tendon rupture, and cataracts. In addition, the administration of steroid injections are limited to being done every three months due to risk of weakening tendons, and acceleration of cartilage loss. There is a void of literature for understating the ideal injectable steroid concentrations in glenohumeral osteoarthritis. Because of this, providers who perform intraarticular injections tend to perform them based on prior training experience or anecdotal evidence. We aim to evaluate the ideal steroid concentration that will maximize treatment effect for glenohumeral osteoarthritis, but at the same time minimize side effects, and better train our future providers.

Interventions

DRUGTriamcinolone

Ultrasound guided glenohumeral shoulder joint injection

Sponsors

Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* An X-ray within a year with Radiographic evidence of OA * 18 years of age or older * Clinical diagnosis established due to symptoms that will include pain attributed to glenohumeral osteoarthritis, pain with range of motion, and/or functional limitations longer than 3 months.

Exclusion criteria

* Previous guided steroid injection of the glenohumeral joint within 3 months * Previous diagnosis of inflammatory arthritis, rotator cuff tear, or immunocompromised * Previous shoulder surgery * Allergy to steroid or lidocaine * A Kellgren and Lawrence classification of 1 or less on radiograph * Non-English Speaking * Inability to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months.baseline, 2, 4, and 6 months. Baseline SPADI score was collected prior to injection.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
Assess Reactions to the Steroidbaseline, 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.

Secondary

MeasureTime frameDescription
Rate of Shoulder Arthroplasty Following Injection12 monthsShoulder arthroplasty is defined as total shoulder replacement
Change in Overall SPADI Scores for Those Receiving Shoulder Arthroplasty at 1 Year12 monthsThe 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

Countries

United States

Participant flow

Participants by arm

ArmCount
20 mg
20mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection
6
40 mg
40mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection
9
80 mg
80mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection
4
Total19

Baseline characteristics

Characteristic20 mg40 mg80 mgTotal
Age, Continuous63.67 years
STANDARD_DEVIATION 12.26
69.33 years
STANDARD_DEVIATION 6.93
64.50 years
STANDARD_DEVIATION 12.29
66.53 years
STANDARD_DEVIATION 9.79
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
2 Participants4 Participants3 Participants9 Participants
Sex: Female, Male
Male
4 Participants5 Participants1 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 90 / 4
other
Total, other adverse events
1 / 62 / 90 / 4
serious
Total, serious adverse events
0 / 60 / 90 / 4

Outcome results

Primary

Assess Reactions to the Steroid

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.

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

ArmMeasureGroupValue (NUMBER)
20 mg Triamcinolone With 3cc of 1% LidocaineAssess Reactions to the Steroid6 month follow up0 Reactions
20 mg Triamcinolone With 3cc of 1% LidocaineAssess Reactions to the Steroid4 month follow up0 Reactions
20 mg Triamcinolone With 3cc of 1% LidocaineAssess Reactions to the Steroid2 month follow up0 Reactions
20 mg Triamcinolone With 3cc of 1% LidocaineAssess Reactions to the SteroidBaseline1 Reactions
40 mg Triamcinolone With 3cc of 1% LidocaineAssess Reactions to the Steroid2 month follow up0 Reactions
40 mg Triamcinolone With 3cc of 1% LidocaineAssess Reactions to the Steroid6 month follow up0 Reactions
40 mg Triamcinolone With 3cc of 1% LidocaineAssess Reactions to the SteroidBaseline2 Reactions
40 mg Triamcinolone With 3cc of 1% LidocaineAssess Reactions to the Steroid4 month follow up0 Reactions
80 mg Triamcinolone With 3cc of 1% LidocaineAssess Reactions to the Steroid6 month follow up0 Reactions
80 mg Triamcinolone With 3cc of 1% LidocaineAssess Reactions to the SteroidBaseline0 Reactions
80 mg Triamcinolone With 3cc of 1% LidocaineAssess Reactions to the Steroid4 month follow up0 Reactions
80 mg Triamcinolone With 3cc of 1% LidocaineAssess Reactions to the Steroid2 month follow up0 Reactions
Primary

Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 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

Time frame: 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

ArmMeasureGroupValue (MEAN)Dispersion
20 mg Triamcinolone With 3cc of 1% LidocaineChange in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months.Baseline SPADI Score58.17 score on a scaleStandard Deviation 17.88
20 mg Triamcinolone With 3cc of 1% LidocaineChange in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months.2 month SPADI Score30.60 score on a scaleStandard Deviation 22.6
20 mg Triamcinolone With 3cc of 1% LidocaineChange in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months.4 month SPADI Score44.80 score on a scaleStandard Deviation 30.11
20 mg Triamcinolone With 3cc of 1% LidocaineChange in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months.6 month SPADI Score44.60 score on a scaleStandard Deviation 25.6
40 mg Triamcinolone With 3cc of 1% LidocaineChange in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months.6 month SPADI Score57.71 score on a scaleStandard Deviation 18.62
40 mg Triamcinolone With 3cc of 1% LidocaineChange in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months.Baseline SPADI Score60.67 score on a scaleStandard Deviation 17.91
40 mg Triamcinolone With 3cc of 1% LidocaineChange in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months.4 month SPADI Score51.12 score on a scaleStandard Deviation 27.53
40 mg Triamcinolone With 3cc of 1% LidocaineChange in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months.2 month SPADI Score48.67 score on a scaleStandard Deviation 22.01
80 mg Triamcinolone With 3cc of 1% LidocaineChange in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months.6 month SPADI Score26.00 score on a scaleStandard Deviation 7.07
80 mg Triamcinolone With 3cc of 1% LidocaineChange in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months.2 month SPADI Score22.25 score on a scaleStandard Deviation 19.97
80 mg Triamcinolone With 3cc of 1% LidocaineChange in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months.4 month SPADI Score35.67 score on a scaleStandard Deviation 34.43
80 mg Triamcinolone With 3cc of 1% LidocaineChange in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months.Baseline SPADI Score44.50 score on a scaleStandard Deviation 18.34
Secondary

Change in Overall SPADI Scores for Those Receiving Shoulder Arthroplasty at 1 Year

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

Time frame: 12 months

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

ArmMeasureValue (MEAN)
20 mg Triamcinolone With 3cc of 1% LidocaineChange in Overall SPADI Scores for Those Receiving Shoulder Arthroplasty at 1 Year2 score on a scale
40 mg Triamcinolone With 3cc of 1% LidocaineChange in Overall SPADI Scores for Those Receiving Shoulder Arthroplasty at 1 Year12 score on a scale
80 mg Triamcinolone With 3cc of 1% LidocaineChange in Overall SPADI Scores for Those Receiving Shoulder Arthroplasty at 1 Year4 score on a scale
Secondary

Rate of Shoulder Arthroplasty Following Injection

Shoulder arthroplasty is defined as total shoulder replacement

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
20 mg Triamcinolone With 3cc of 1% LidocaineRate of Shoulder Arthroplasty Following Injection3 Participants
40 mg Triamcinolone With 3cc of 1% LidocaineRate of Shoulder Arthroplasty Following Injection1 Participants
80 mg Triamcinolone With 3cc of 1% LidocaineRate of Shoulder Arthroplasty Following Injection1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026