Shoulder Corticosteroid Injection in Diabetic Patients

August 29, 2018 updated by: Enrico Bellato, University of Turin, Italy

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemia
Time Frame: Patients were requested to measure their blood sugar levels 4 times a day for the following 7 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant Score (CS)
Time Frame: 30 days post-injection, 6 months post-injection

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
Oxford Shoulder Score (OSS)
Time Frame: 30 days post-injection, 6 months post-injection
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
Subjective Shoulder Value (SSV)
Time Frame: 30 days post-injection, 6 months post-injection
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
Subjective Outcomes Determination (SOD) score
Time Frame: 30 days post-injection, 6 months post-injection
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

September 30, 2014

Study Registration Dates

First Submitted

August 25, 2018

First Submitted That Met QC Criteria

August 28, 2018

First Posted (Actual)

August 29, 2018

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 29, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHOULDERDM2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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