Shoulder Corticosteroid Injection in Diabetic Patients

NCT03652480 | Completed

• 1 other identifier: SHOULDERDM2013
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shoulder Pain; Corticosteroid Injection; Type2 Diabetes Mellitus

Keywords

shoulder pain; type 2 diabetes; subacromial corticosteroid injection; glycemia; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Interventions

MethylPREDNISolone Acetate 40 MG/ML DRUG

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type-2 diabetic patients affected complaining of chronic shoulder pain resistant to at least 6 months of conservative therapy (NSAIDs, painkillers and physiotherapy).

You may qualify if:

• 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

You may not qualify if:

• 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).
• High blood pressure values (systolic blood pressure \>140mmHg, diastolic blood pressure \>80mmHg).
• Glaucoma.

Sponsors & Collaborators

• University of Turin, Italy: lead

Related Publications (1)

• 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.

  PMID: 30327731 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Diabetes Mellitus, Type 2

Interventions

Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: August 25, 2018
• First Posted: August 29, 2018
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: September 30, 2014
• Last Updated: August 31, 2018

Record last verified: 2018-08