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Shoulder Corticosteroid Injection in Diabetic Patients | Clinical Trials | Clareo Health

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Shoulder Corticosteroid Injection in Diabetic Patients

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

NCT03652480•University of Turin, Italy

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.

Eligibility

Age

40 - 85 years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

March 1, 2013

Primary Completion Date

March 1, 2014

Completion Date

September 30, 2014

Last Updated

August 31, 2018

Enrollment

ACTUAL participants

Conditions

Shoulder PainCorticosteroid InjectionType2 Diabetes Mellitus

Interventions

MethylPREDNISolone Acetate 40 MG/ML

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 31, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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