An observational study in Shoulder Pain, Corticosteroid Injection and Type2 Diabetes Mellitus, sponsored by University of Turin, Italy. Completed. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-08-31.
Sponsored by University of Turin, Italy · Observational
In type 2 diabetic patients affected by chronic shoulder pain, subacromial injection with corticosteroid could be an effective treatment. The aim of this study was to measure the risk-benefit ratio of this treatment.Twenty patients with well-controlled diabetes were included in a prospective study. In a first pre-injection phase, patients were asked to measure glycemia for 7 days, before breakfast and dinner, then 2 hours after lunch and dinner. Baseline data including Constant Score (CS), Subjective Shoulder Value (SSV) and Numerical Rating Scale (NRS) for pain were collected. Patients were treated with subacromial injection with 40mg of Methylprednisolone Acetate and 2ml of Lidocaine. At discharge, patients were asked to re-measured glycemia for the following week.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 20 is below the median of 82 across 130 observational studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →University of Turin, Italy is the lead sponsor of 206 studies on the registry; 34 are open to participants now.
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Type-2 diabetic patients affected complaining of chronic shoulder pain resistant to at least 6 months of conservative therapy (NSAIDs, painkillers and physiotherapy).
Well-controlled type-2 diabetes, defined as:
Exclusion Criteria:
Glycemia
Post-injections glucose blood levels (mg/dl)
Time frame: Patients were requested to measure their blood sugar levels 4 times a day for the following 7 days
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.
Time frame: 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
Time frame: 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%
Time frame: 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
Time frame: 30 days post-injection, 6 months post-injection
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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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University of Turin, Italy