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临床试验/NCT03779919
NCT03779919Unknown不适用

The Therapeutic Effect of the Extracorporeal Shock Wave Therapy on Shoulder Calcific Tendinitis

Chimei Medical Center1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年11月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
1
主要终点
changes from baseline in the calcium deposits

研究概览

简要总结

Calcific tendinopathy of the shoulder is often self-limited with a relatively benign clinical course. Therefore, first-line therapy should be conservative and focused on symptom relief. However, studies show patients with Large volume deposits (e.g. ≥1500 mm3) and Subacromial extension of the deposits respond poorly to initial treatment such as analgesic medication, glucocorticoid injection, and physical therapy. For those refractory cases, extracorporeal shock wave therapy is introduced and shows resolution of symptoms and improvement in shoulder function in approximately 70 percent of patients.

Extracorporeal shock wave therapy uses acoustic waves to fragment calcific deposits. Variables of the settings include dose (low or high energy), duration (impulses), and the interval of administration. However, an optimum value for the total cumulative dose of energy that should be administered has not yet been defined. Our study thus aim to find out the dosage effect of ESWT on the calcific debris sizes, pain, daily living functions, and shoulder range of motions in the calcific tendinitis patients.

详细描述

Calcific tendinopathy of the shoulder is caused by unknown etiology characterized by the formation of calcific deposits in on or several tendons of the rotator cuff muscles: supraspinatus, infraspinatus, teres minor, and subscapularis muscles. The calcific deposits is often composed of poorly crystallized hydroxyapatite, an inorganic component of bone tissue, but the pathogenesis of rotator cuff disorders is still incomplete.

The clinical presentations of calcific tendinopathy typically involve shoulder pain similar to that experienced by patients with rotator cuff tendinopathy or shoulder impingement syndrome. Pain is the cardinal symptom and is localized on the top or lateral aspect of the shoulder or both, often with radiation towards the insertion of the deltoid. The onset of pain is gradual and unassociated with trauma. Daily activities involving overhead motions, such as putting on a shirt or brushing hair, can be painful, thus decreasing quality of life immensely.

Calcific tendinopathy of the shoulder is often self-limited with a relatively benign clinical course. Therefore, first-line therapy should be conservative and focused on symptom relief. However, some remain ineffective to the initial treatment. For those refractory cases, extracorporeal shock wave therapy (ESWT) is introduced and shows resolution of symptoms and improvement in shoulder function in approximately 70 percent of patients.

ESWT uses acoustic waves to fragment calcific deposits. Variables of the settings include dose (low or high energy), duration (impulses), and the interval of administration. However, an optimum value for the total cumulative dose of energy that should be administered has not yet been defined. Our study thus aim to find out the dosage effect of ESWT on the calcific debris sizes, pain, daily living functions, and shoulder range of motions in the calcific tendinitis patients.

The study will be a prospective assessor-blinded randomized controlled trial. Patients who have calcific tendinitis diagnosed by shoulder sonography or X-ray, fail to improve despite appropriate conservative treatment for three months will be recruited. The subjects will be randomized distributed in 3 groups: High Energy, Low Energy, and Sham groups, and each group has 30 patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •.age 20-70 with calcific tendinitis via sonography or x-ray in rotator cuff

排除标准

  • •.no shoulder fracture, no abnormality, gout or autoimmune disease

研究组 & 干预措施

High Energy

Experimental

Extracorporeal shock wave therapy with 0.3 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.

干预措施: extracorporeal shock wave (Device)

Low Energy

Experimental

Extracorporeal shock wave therapy with 0.05 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.

干预措施: extracorporeal shock wave (Device)

Sham

Placebo Comparator

Extracorporeal shock wave therapy with 0 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.

干预措施: extracorporeal shock wave (Device)

结局指标

主要结局

changes from baseline in the calcium deposits

时间窗: one month and 3 months after shock wave

Calcium deposits will be measured via X-ray or sonography.

次要结局

  • pain score(one month and 3 months after shock wave)
  • functional score(one month and 3 months after shock wave)

研究者

发起方
Chimei Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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