Shoulder Corticosteroid Injection in Diabetic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Shoulder Pain Corticosteroid Injection Type2 Diabetes Mellitus

Keywords

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shoulder pain type 2 diabetes subacromial corticosteroid injection glycemia efficacy safety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MethylPREDNISolone Acetate 40 MG/ML

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Enrico Bellato

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Blonna D, Bonasia DE, Mattei L, Bellato E, Greco V, Rossi R. Efficacy and Safety of Subacromial Corticosteroid Injection in Type 2 Diabetic Patients. Pain Res Treat. 2018 Sep 20;2018:9279343. doi: 10.1155/2018/9279343. eCollection 2018.

Reference Type DERIVED

PMID: 30327731 (View on PubMed)

Other Identifiers

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SHOULDERDM2013

Identifier Type: -

Identifier Source: org_study_id