Diabetes Mellitus Clinical Trial
Official title:
A Randomized Single Blinded Prospective Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
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.
Day 1: Patient will be seen in the clinic. Patient will be provided information about the
study, consented and recruited to the study. Obtain pre-injection HbA1c. If no previous
HbA1c, obtain a new one on the following day in the morning Injection will be administered to
the patient. Pain score will be obtained prior to injection and 5 min after injection. Blood
glucose measurement will be started in an hour of the injection and will last for one week
after the injection.
Day 3: Patients will be contacted by phone for pain score.
1 Week: Patients will be contacted by phone for pain score. 2 Weeks: Patient will be seen at
clinic for a follow up and for pain score. 4 Weeks: Patient will be seen at clinic for pain
score and for range of motion, QuickDASH, and ASES scores.
6 Weeks: Patients will be contacted by phone for pain score. 8 Weeks: Patient will be seen at
clinic for pain score and for range of motion, QuickDASH, and ASES scores.
12 Weeks: Patient will be seen at clinic for pain score and for range of motion, QuickDASH,
and ASES scores.
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