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Clinical Trial Details

Trial ID: L4671
Source ID: NCT03319784
Associated Drug: Ketorolac
Title: Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Rotator Cuff Tear|Rotator Cuff Injury|Rotator Cuff Tendinitis|Diabetes Mellitus
Interventions: DRUG: Ketorolac|DRUG: Triamcinolone Acetonide
Outcome Measures: Primary: 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: 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.
Sponsor/Collaborators: Sponsor: Milton S. Hershey Medical Center
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2018-09-05
Completion Date: 2020-10-05
Results First Posted:
Last Update Posted: 2019-02-15
Locations: Penn State College of Medicine, Hershey, Pennsylvania, 17033, United States
URL: https://clinicaltrials.gov/show/NCT03319784