Osteoarthritis Shoulder Injection Study

Phase 4

Terminated

Conditions: Glenohumeral Osteoarthritis

Interventions: Drug: Triamcinolone

Registration Number: NCT03586687

Lead Sponsor: Milton S. Hershey Medical Center

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 19

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20 mg Triamcinolone with 3cc of 1% Lidocaine	Triamcinolone	20mg Triamcinolone with 3cc of 1% Lidocaine
40 mg Triamcinolone with 3cc of 1% Lidocaine	Triamcinolone	40mg Triamcinolone with 3cc of 1% Lidocaine
80 mg Triamcinolone with 3cc of 1% Lidocaine	Triamcinolone	80mg Triamcinolone with 3cc of 1% Lidocaine

Primary Outcome Measures

Name	Time	Method
Assess Reactions to the Steroid	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.
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

Secondary Outcome Measures

Name	Time	Method
Change in Overall SPADI Scores for Those Receiving Shoulder Arthroplasty at 1 Year	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
Rate of Shoulder Arthroplasty Following Injection	12 months	Shoulder arthroplasty is defined as total shoulder replacement