Arthritis Trial Finder

Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients that are 18 years old or older that have rotator cuff tendinitis and a low-grade partial thickness tear of the rotator cuff confirmed with an imaging study (ultrasound or MRI) with either insulin dependent or insulin independent diabetes.

Exclusion Criteria:

  • - Patients whom are younger than 18 years old, pregnant women, and prisoners will be excluded.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03319784

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 4

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Milton S. Hershey Medical Center

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
H. Mike Kim, MD
Principal Investigator Affiliation Penn State College of Medicine

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Not yet recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Rotator Cuff Tear, Rotator Cuff Injury, Rotator Cuff Tendinitis, Diabetes Mellitus
Additional Details

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.

Contact a Trial Team

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Penn State College of Medicine, Hershey, Pennsylvania

Status

Not yet recruiting

Address

Penn State College of Medicine

Hershey, Pennsylvania, 17033

Site Contact

H. MIke Kim, MD

717-531-4826

Nearest Location

Site Contact

H. MIke Kim, MD

717-531-4826

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