CSI: Effect of Corticosteroid Injections on Blood Glucose

Sponsor

Duke University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05048264

Collaborator

(none)

124

Enrollment

Location

Arms

20.5

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to measure the effect of various corticosteroid formulations administered to the glenohumeral joint in diabetic patients on resultant blood glucose readings. In addition, the investigator is looking to quantify the effect of various corticosteroid formulations administered to the glenohumeral joint via ultrasound-guided injection on WORC and ASES scores in study patients.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Steroid Diabetes Shoulder Pain	Drug: Kenalog 40 MG Drug: Dexamethasone 4mg Drug: Celestone Drug: Depo-medrol	Phase 2

Detailed Description

The purpose of this study is to measure the effect of various corticosteroid formulations administered to the glenohumeral joint in diabetic patients on resultant blood glucose readings. The investigator also aim to quantify the effect of various corticosteroid formulations administered to the glenohumeral joint via ultrasound-guided injection on WORC and ASES scores in study patients.

Corticosteroid injections (CSI) are frequently used in orthopedic settings in order to treat a wide array of orthopedic issues, including osteoarthritis, bursitis, tendinitis, and many others. The effect of diabetes on the musculoskeletal system and its role in orthopedic disease has been well-documented. Current evidence demonstrates that corticosteroids, even when administered through a local musculoskeletal injection, can lead to temporary increases in blood glucose. Ultrasound guidance was not explicitly used in any of the studies examining the impact of steroids on blood glucose. The utilization of ultrasound guidance has been shown to increase accuracy when performing injections into the subacromial space as well as the glenohumeral joint when compared to palpation/landmark-guided injections.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Corticosteroid Injections Administered Under Ultrasound Guidance to Diabetic Patients and the Effect on Blood Glucose

Anticipated Study Start Date :

Oct 3, 2022

Anticipated Primary Completion Date :

Apr 2, 2024

Anticipated Study Completion Date :

Jun 17, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Kenalog 40 mg Thirty-one subjects will be randomized to this arm. Each subject randomized to this arm will receive one 40 mg corticosteroid injection of Kenalog in the index shoulder.	Drug: Kenalog 40 MG 40 MG/ML Injectable Suspension Other Names: Triamcinolone acetonide
Active Comparator: Dexamethasone 4 mg Thirty-one subjects will be randomized to this arm. Each subject randomized to this arm will receive one 4 mg corticosteroid injection of Dexamethasone in the index shoulder.	Drug: Dexamethasone 4mg 4 Mg/mL Injectable Solution
Active Comparator: Celestone 6 mg Thirty-one subjects will be randomized to this arm. Each subject randomized to this arm will receive one 6 mg corticosteroid injection of Celestone in the index shoulder.	Drug: Celestone 6 MG/ML Injectable Suspension Other Names: Betamethasone
Active Comparator: Depo-medrol 40 mg Thirty-one subjects will be randomized to this arm. Each subject randomized to this arm will receive one 40 mg corticosteroid injection of Depo-Medrol in the index shoulder.	Drug: Depo-medrol 40 MG/ML Injectable Suspension Other Names: Methylprednisolone

Outcome Measures

Primary Outcome Measures

Change in blood glucose measures [Baseline & 2 weeks]
Reported daily glucose measures from baseline to subjects two-week appointment

Secondary Outcome Measures

Change in patient reported outcomes [Baseline, 2 weeks, 6 weeks, 3 months]
Results of patient reported outcomes via WORC scores
Change in patient reported outcomes [Baseline, 2 weeks, 6 weeks, 3 months]
Results of patient reported outcomes via ASES scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Known diabetic patients ages 40-75 undergoing clinically indicated standard of care corticosteroid glenohumeral joint injection
Ability to perform daily blood glucose testing
Can receive and send text messages

Exclusion Criteria:

Previous joint arthroplasty
Corticosteroid injection at other sites in the body or in the shoulder within the past month
Systemic corticosteroid within the last month other than asthma inhaler
Anyone who are unable to read and/or understand English
Pregnant women (self-report)
Any clinical reason why any of the four medication options would not be safe or equally efficacious as the others