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Completed

NCT Number: NCT03652480

Shoulder Corticosteroid Injection in Diabetic Patients

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.

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Key information

Conditions

Shoulder Pain Arthralgia Corticosteroid Injection Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Joint Diseases Metabolic Diseases Musculoskeletal Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Type2 Diabetes Mellitus

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MethylPREDNISolone Acetate 40 MG/ML

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 29, 2018
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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