Efficacy and Safety of Subacromial Corticosteroid Injection in Type-2 Diabetic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Glycemia
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Glycemia
时间窗: 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)
次要结局
- Subjective Shoulder Value (SSV)(30 days post-injection, 6 months post-injection)
- Constant Score (CS)(30 days post-injection, 6 months post-injection)
- Oxford Shoulder Score (OSS)(30 days post-injection, 6 months post-injection)
- Subjective Outcomes Determination (SOD) score(30 days post-injection, 6 months post-injection)
研究者
Enrico Bellato
Researcher
University of Turin, Italy