Shoulder Corticosteroid Injection in Diabetic Patients

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652480
• Other study ID #: SHOULDERDM2013
• Status: Completed
• Start date: March 2013
• Est. completion date: September 30, 2014

Study information

• Verified date: August 2018
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corticosteroid Injection
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Shoulder Pain
• Type2 Diabetes Mellitus

Intervention

Drug:
• MethylPREDNISolone Acetate 40 MG/ML

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Constant Score (CS)	The CS is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.; Subjective findings (severity of pain, activities of daily living and working in different positions) of the participants are responsible for 35 points and objective measurements (active range of motion without pain, measurements exo -and endorotation via reference points and measuring muscle strength) are responsible for the remaining 65 points.	30 days post-injection, 6 months post-injection
Secondary	Oxford Shoulder Score (OSS)	The OSS questionnaire contains 12 items, each with five potential answers. Patients are asked to rate their symptoms between 1 (minimal symptoms) and 5 (severe symptoms). The combined total gives a minimum score of 12 and a maximum of 60	30 days post-injection, 6 months post-injection
Secondary	Subjective Shoulder Value (SSV)	The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%	30 days post-injection, 6 months post-injection
Secondary	Subjective Outcomes Determination (SOD) score	The SOD score is a simple tool with a categorical and a numerical component to compare surgical outcomes to both the preoperative status as well as to the preinjury state. Patients are asked to compare how they feel currently to how they felt before their surgery and to state if they overall consider themselves to be better, worse ore they are not sure. If they feel better, they are asked to indicate if they consider the operated part of the body to be Improved, Greatly improved, Almost Normal, or Normal. If they feel worse, the respondent is asked if they are Worse, Profoundly Worse, or As Bad As Dying	30 days post-injection, 6 months post-injection