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Clinical Trial Details

Trial ID: L2521
Source ID: NCT03652480
Associated Drug: Methylprednisolone Acetate 40 Mg/Ml
Title: Shoulder Corticosteroid Injection in Diabetic Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Shoulder Pain|Corticosteroid Injection|Type2 Diabetes Mellitus
Interventions: DRUG: MethylPREDNISolone Acetate 40 MG/ML
Outcome Measures: Primary: Glycemia, Post-injections glucose blood levels (mg/dl), Patients were requested to measure their blood sugar levels 4 times a day for the following 7 days | Secondary: Constant Score (CS), The CS is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. Subjective findings (severity of pain, activities of daily living and working in different positions) of the participants are responsible for 35 points and objective measurements (active range of motion without pain, measurements exo -and endorotation via reference points and measuring muscle strength) are responsible for the remaining 65 points., 30 days post-injection, 6 months post-injection|Oxford Shoulder Score (OSS), The OSS questionnaire contains 12 items, each with five potential answers. Patients are asked to rate their symptoms between 1 (minimal symptoms) and 5 (severe symptoms). The combined total gives a minimum score of 12 and a maximum of 60, 30 days post-injection, 6 months post-injection|Subjective Shoulder Value (SSV), The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%, 30 days post-injection, 6 months post-injection|Subjective Outcomes Determination (SOD) score, The SOD score is a simple tool with a categorical and a numerical component to compare surgical outcomes to both the preoperative status as well as to the preinjury state. Patients are asked to compare how they feel currently to how they felt before their surgery and to state if they overall consider themselves to be better, worse ore they are not sure. If they feel better, they are asked to indicate if they consider the operated part of the body to be Improved, Greatly improved, Almost Normal, or Normal. If they feel worse, the respondent is asked if they are Worse, Profoundly Worse, or As Bad As Dying, 30 days post-injection, 6 months post-injection
Sponsor/Collaborators: Sponsor: University of Turin, Italy
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 20
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2013-03
Completion Date: 2014-09-30
Results First Posted:
Last Update Posted: 2018-08-31
Locations:
URL: https://clinicaltrials.gov/show/NCT03652480