Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients

Summary

Sixty patients will be identified in the clinic with rotator cuff tendonitis or a low-grade partial-thickness tear of the rotator cuff that are either insulin-dependent or insulin-independent diabetics. Patients will be informed about the current prospective study and written consent will be obtained. Patient information about kidney function, current diabetic medication type, dose and frequency will be obtained in clinic. If there is a diagnosed kidney function abnormality, the patient will be excluded from the study. Patients will be asked about their most recent HbA1C. If HbA1C has not been checked within the past 3 months, the patient will have HbA1C checked in the lab either same day as the injection or the following day. Patients will be randomized into two patient groups: Toradol (Ketorolac) injection group (n=30) and or Steroid injection group (n=30). The randomization will be done using an online randomization tool: http://www.graphpad.com/quickcalcs/index.cfm.

Patients assigned to Toradol group will receive 60mg of Toradol (Ketorolac) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000. Those assigned to Steroid group will receive 80mg of Kenalog (Triamcinolone Acetonide) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000.

Patients will be blinded to the kind of injection they receive, but the physicians who perform the injection will not be blinded for the medical record purposes. The injection will be done under ultrasound guidance to the subacromial space. Continuous blood glucose measurement will be started in an hour within the injection. An instructional session about continuous glucose monitoring will be given to the patients by our research team immediately following the injection. The blood glucose levels will be monitored for 1 week following the injection. The data will be collected on the patient's return to clinic in 2 weeks. Pain score based on a visual analog scale will be obtained prior to injection, 5 min, 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after injection. Shoulder range of motion, patient satisfaction, QuickDash score, and ASES survey score will be measured in clinic 4, 8, and 12 weeks after injection.

Conditions

• Rotator Cuff Tear
• Rotator Cuff Injury
• Rotator Cuff Tendinitis
• Diabetes Mellitus

Interventions

DRUG

Ketorolac

Patients assigned to Toradol group will receive a single dose of 60mg of Ketorolac (Toradol) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000.

DRUG

Triamcinolone Acetonide

Patients assigned to Steroid group will receive 80mg of Triamcinolone Acetonide (Kenalog) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000.

Sponsors & Collaborators

• Milton S. Hershey Medical Center

  lead OTHER

Principal Investigators

• H. Mike Kim, MD · Penn State College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-05

Primary Completion

2020-09-05

Completion

2020-10-05

FDA Drug

Yes

Countries

• United States

Study Locations