Ultrasound-guided Lavage of Calcific Deposits of the Rotator Cuff: The Role of Power Doppler Sonography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PDUS signal intensity
研究概览
简要总结
The primary goal of the study is to assess ultrasonographic Power Doppler signals after ultrasound-guided puncture and lavage of rotator cuff calcific tendinitis of the shoulder. Secondary outcomes are sonographic features like the course of residual calcific material and the course of tendon healing als well as the clinical symptoms of the patient.
详细描述
In our study we investigate the intensity of the power doppler signal after ultrasound-guided puncture and lavage (UGPL) of the rotator cuff calcific tendinitis. We assume that UGPL will lead to intratendinous neovascularisation and that the amount of retrieved calcific material is associated with the PDUS signal. The measurement of the signal will be performed in pre determined time slot for 12 months. Additional we study the correlation between the PDUS signal and the clinical symptoms of the patient and the healing process.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 years and older
- •Pain in the deltoid region worsening with activities above shoulder level and/or at night with a calcific deposit
- •Ultrasound evaluation of the calcific deposit with type I or II characteristics, a solitary conformation, a minimum size of 1.0 x 0.5 x 0.4cm (length x width x depth) and without clear signs of resorption (PDUS grade 0 - I°, see study procedure).
- •In case of multiple calcific deposits, it has to be warranted that the other deposits are smaller than the minimum size of 1.0 x 0.5 x 0.4cm and with no signs of PDUS signals.
- •Qualification for more intensive treatment on account of no clinical improvement after a minimum of 3 months with conservative treatment (physical therapy and oral anti-inflammatory drugs).
- •able to understand the content of the patient information / consent form in German and give consent to take part in the project
排除标准
- •Previous UGPL or surgery of the affected shoulder
- •Treatment with subacromial injection (SAI) or ESWT in the three months before inclusion
- •Other causes of shoulder complaints (e.g. rotator cuff tear, frozen shoulder, inflammatory arthritis, bursitis, ...)
- •Intervention failure (no retrieval of calcific material, leakage of the injected saline, disruption of the calcific rim or distribution of calcific material)
- •Patients with a language barrier hindering questionnaire completion
- •Pregnancy
结局指标
主要结局
PDUS signal intensity
时间窗: One year after intervention
Power doppler ultrasonography (PDUS) signal intensity
次要结局
- Constant Murley Score (CMS)(One year after intervention)
- Shoulder function parameters(One year after intervention)
- Level of improvement(One year after intervention)
- Tendon rupture(One year after intervention)
- Subjective shoulder value (SSV)(One year after intervention)
- Pain level(One year after intervention)
- Residual calcific material(One year after intervention)