Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus; Rotator Cuff Tear; Rotator Cuff Tendinitis; Rotator Cuff Injury
• Intervention / Treatment: Drug: Ketorolac; Drug: Triamcinolone Acetonide

Detailed Description

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ketorolac (Toradol) Injection Group; 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; 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.; Other Names: Toradol
ACTIVE_COMPARATOR: Steroid Injection Group; 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; Patients assigned to Steroid group will receive 80mg of Triamcinolone Acetonide (Kenalog) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000.; Other Names: Kenalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	Pain scores will be measured using the Visual Analog Scale. Scale: 0 - 10 0 - No pain; 5- Moderate pain; 10 - Extreme pain Lower values = better outcome No subscales will be used	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	Patients will be asked to fill out a questionnaire asking their satisfaction level regarding the treatment.	Patient satisfaction will be measured in clinic 4, 8, and 12 weeks after injection.
QuickDASH	The QuickDASH is a shortened version of the DASH (Disabilities of the Arm, Shoulder, and Hand) Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.	QuickDash score will be measured in clinic 4, 8, and 12 weeks after injection.
American Shoulder and Elbow Surgeon (ASES) Shoulder Score	The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. For this study, we will not be using the physician-rated questionnaire and no subscales will be used. ASES Patient-rated questionnaire Total of 100 maximum points (Weighted 50% for pain and 50% for function) -Higher the score, better the outcome Pain portion: -The final pain score (maximum 50 points) is calculated by subtracting the Visual Analog Scale (VAS) from 10 and multiplying by five. Functional portion: 10 questions rated on a 4-point ordinal scale (from 0-3); Maximum of 30 points. The raw score is multiplied by 5/3 to make the maximal functional score out of 50 possible points. The pain and functional portions are then summed to obtain the final ASES score.	ASES survey score will be measured in clinic 4, 8, and 12 weeks after injection.

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: H. Mike Kim, MD, Penn State College of Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 5, 2018
• Primary Completion (ANTICIPATED): September 5, 2020
• Study Completion (ANTICIPATED): October 5, 2020

Study Registration Dates

• First Submitted: September 16, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (ACTUAL): October 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 11, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Tendinopathy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Ketorolac; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: STUDY00008014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No