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

Shoulder Corticosteroid Injection in Diabetic Patients

Sponsors

Lead sponsor: University of Turin, Italy

Source University of Turin, Italy
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.

Overall Status Completed
Start Date March 2013
Completion Date September 30, 2014
Primary Completion Date March 2014
Study Type Observational
Primary Outcome
Measure Time Frame
Glycemia Patients were requested to measure their blood sugar levels 4 times a day for the following 7 days
Secondary Outcome
Measure Time Frame
Constant Score (CS) 30 days post-injection, 6 months post-injection
Oxford Shoulder Score (OSS) 30 days post-injection, 6 months post-injection
Subjective Shoulder Value (SSV) 30 days post-injection, 6 months post-injection
Subjective Outcomes Determination (SOD) score 30 days post-injection, 6 months post-injection
Enrollment 20
Condition
Intervention

Intervention type: Drug

Intervention name: MethylPREDNISolone Acetate 40 MG/ML

Eligibility

Sampling method: Non-Probability Sample

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.

Gender: All

Minimum age: 40 Years

Maximum age: 85 Years

Healthy volunteers: No

Verification Date

August 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Turin, Italy

Investigator full name: Enrico Bellato

Investigator title: Researcher

Keywords
Has Expanded Access No
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Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov