Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients

NCT03319784 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STUDY00008014
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in blood glucose level

  The peak and average glucose levels, and duration of the increase will be used as the surrogates of the primary outcome. The peak and average glucose levels will both share the same unit of measure (mg/dL). The duration of the increase will measure the number of hours that the patient experienced an increasing level of glucose.

  Participants' blood glucose will be measured 5 minutes after injection and three times daily for one week following injection; Alternatively, using Continuous Glucose Monitoring sensors, blood glucose will be monitored for 1 week following injection.

Secondary Outcomes (5)

• Visual Analog Scale

  Pain scores 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

  Shoulder range of motion will be measured in clinic 4, 8, and 12 weeks after injection.

• Patient Satisfaction

  Patient satisfaction will be measured in clinic 4, 8, and 12 weeks after injection.

• QuickDASH

  QuickDash score will be measured in clinic 4, 8, and 12 weeks after injection.

• American Shoulder and Elbow Surgeon (ASES) Shoulder Score

  ASES survey score will be measured in clinic 4, 8, and 12 weeks after injection.

Study Arms (2)

Ketorolac (Toradol) Injection Group

ACTIVE COMPARATOR

Patients will be randomized into two patient groups: Ketorolac (Toradol) injection group (n=30) and or Steroid injection group (n=30). Patients assigned to Ketorolac group will receive a single dose of 60mg of Ketorolac (Toradol) 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.

Drug: Ketorolac

Steroid Injection Group

ACTIVE COMPARATOR

Patients will be randomized into two patient groups: Ketorolac (Toradol) injection group (n=30) and or Steroid injection group (n=30). Patients assigned to Steroid group will receive a single dose of 80mg of Triamcinolone Acetonide (Kenalog) 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.

Drug: Triamcinolone Acetonide

Interventions

Ketorolac DRUG

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.

Also known as: Toradol

Ketorolac (Toradol) Injection Group

Triamcinolone Acetonide DRUG

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

Also known as: Kenalog

Steroid Injection Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Diabetes Mellitus

Interventions

Ketorolac; Ketorolac Tromethamine; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• H. Mike Kim, MD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedics

Study Record Dates

• First Submitted: September 16, 2017
• First Posted: October 24, 2017
• Study Start: September 5, 2018
• Primary Completion: September 5, 2020
• Study Completion: October 5, 2020
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

US (1)