Shoulder Corticosteroid Injection in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Efficacy and Safety of Subacromial Corticosteroid Injection in Type-2 Diabetic

Conditions
-----------------
Shoulder Pain, Corticosteroid Injection, Type2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: MethylPREDNISolone Acetate 40 MG/ML


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consent to participate in the study. Severe overall pain and night pain: Numerical Rating Scale (NRS) for pain[8] above or equal to 60/100; the scale was modified from 0-10 to 0-100 (0 = no pain 100 = unbearable pain). No significant improvement after at least 2 courses of physiotherapy (including direct assistance from a physical therapist with specific exercises, manual therapy, and physical agents in order to reduce inflammation and pain). Clinical signs of subacromial tendinobursitis, with or without signs of rotator cuff tear, defined as positive Neer, Yocum and Hawkins tests[9-15]. Pain experienced during the execution of these tests needed to reproduce the type of pain that patients complained the most. No indication for surgery due to the age, concomitant comorbidities or patient's refusal to undergo surgery. Well-controlled type-2 diabetes, defined as: Fasting and pre-prandial blood glucose levels in the range of 90- 150mg/dL. Hb1Ac <64mmol/mol (corresponding to 8%) measured within 6 months. A device for self-measurement of blood sugar levels at home Patients need to have a recent (within 6 months) x-ray and an MRI or ultrasound of the affected shoulder Exclusion Criteria: Corticosteroid treatment in the past 3 months. Complaints of shoulder stiffness more than shoulder pain. Symptomatic glenohumeral arthritis defined as shoulder stiffness plus moderate radiographic signs of arthritis (grade >2 according to Hamada classification and grade >1 according to Samilson-Prieto classification for eccentric and concentric arthritis respectively). Shoulder trauma within 3 months of inclusion evaluation for in this study. High blood pressure values (systolic blood pressure >140mmHg, diastolic blood pressure >80mmHg). Glaucoma.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MethylPREDNISolone Acetate 40 MG/ML|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shoulder pain, type 2 diabetes, subacromial corticosteroid injection, glycemia, efficacy, safety