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NCT03319784

Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients

Withdrawn Phase 4 Last updated 15 February 2019
What this trial tests

Phase 4 trial testing Ketorolac in Rotator Cuff Tear. Withdrawn.

Timeline
5 September 2018
Primary endpoint
5 September 2020
5 October 2020

Quick facts

Lead sponsorMilton S. Hershey Medical Center
PhasePhase 4
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Start date5 September 2018
Primary completion5 September 2020
Estimated completion5 October 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Milton S. Hershey Medical Center

Who can join

18 and older, any sex, with Rotator Cuff Tear or Rotator Cuff Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Ketorolac

Trials testing the same drug.

Other recruiting trials for Rotator Cuff Tear

Currently open trials in the same condition.

Other Milton S. Hershey Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing