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Shoulder Corticosteroid Injection in Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652480
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Enrico Bellato, University of Turin, Italy

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.

Condition or disease Intervention/treatment
Shoulder Pain Corticosteroid Injection Type2 Diabetes Mellitus Drug: MethylPREDNISolone Acetate 40 MG/ML

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy and Safety of Subacromial Corticosteroid Injection in Type-2 Diabetic
Actual Study Start Date : March 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : September 30, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.


  2. 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

  3. 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%

  4. 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



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Enrico Bellato, Researcher, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT03652480    
Other Study ID Numbers: SHOULDERDM2013
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Keywords provided by Enrico Bellato, University of Turin, Italy:
shoulder pain
type 2 diabetes
subacromial corticosteroid injection
glycemia
efficacy
safety
Additional relevant MeSH terms:
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Shoulder Pain
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents