Clinical trial NCT03652480: Shoulder Corticosteroid Injection in Diabetic Patients
Official title: Efficacy and Safety of Subacromial Corticosteroid Injection in Type-2 Diabetic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Pain
Corticosteroid Injection
Type2 Diabetes Mellitus
Keywords: shoulder pain
type 2 diabetes
subacromial corticosteroid injection
glycemia
efficacy
safety
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


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.

Primary outcomes:
measure: Glycemia
timeFrame: Patients were requested to measure their blood sugar levels 4 times a day for the following 7 days
Secondary outcomes:
measure: Constant Score (CS)
timeFrame: 30 days post-injection, 6 months post-injection
measure: Oxford Shoulder Score (OSS)
timeFrame: 30 days post-injection, 6 months post-injection
measure: Subjective Shoulder Value (SSV)
timeFrame: 30 days post-injection, 6 months post-injection
measure: Subjective Outcomes Determination (SOD) score
timeFrame: 30 days post-injection, 6 months post-injection
Other outcomes:
Locations:
Study officials:
References:
citation: 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.