跳至主要内容
临床试验/NCT02275689
NCT02275689已完成不适用

Alternative Treatment of Rotator Cuff Tendinopathy

University Hospital of North Norway2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2015年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
2
主要终点
Change from baseline in VAS for pain

研究概览

简要总结

This study compare the outcome (pain, function) after Radiofrequency microtenotomy (group I) and acromioplasty (group II) for treatment of rotator cuff tendinosis in the shoulder.

The outcome of both methods will be compared to the physical therapy treatment (groupIII)

详细描述

Rotator cuff tendinosis cause pain and disability of the shoulder. Tendinosis, sometimes complicated by partial rupture, appears to be the major lesion in chronic rotator cuff tendinopathy. Important features is a poor intrinsic ability to heal.

Several patients receive treatment for shoulder tendinosis each year. Conservative treatments options include rest, stretching, strengthening, ice and/or physical therapy are used with difference results. A traditional surgical treatments (acromioplasty) have been reported with variable results..

The aim of this study is to evaluate improvement of VAS and functionality using Constant score before and after treatment of rotator cuff tendinosis using radiofrequency-plasma based microtenotomy in comparison to traditional acromioplasty and physical therapy.

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
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Impingement pain in the shoulder at least 3 months
  • MRI of shoulder reveal tendinosis
  • Classification of Acromion morphology by RTG and or MRI
  • daily pain

排除标准

  • inflammatory joint disease
  • Other comorbidity in the shoulder as instability, osteoarthritis or rotator cuff tear
  • serious illness

研究组 & 干预措施

Arthrocopic acromioplasty

Active Comparator

Surgical intervention with arthroscopic acromioplasty, bursectomy and subacromial decompression

干预措施: Arthroscopic acromioplasty (Procedure)

Radiofrequency microtenotomy

Active Comparator

Surgical intervention With arthroscopic radiofrequency microtenotomy

干预措施: Microtenotomy (Procedure)

Physical therapy

No Intervention

Muscle strength training, home trainings programme

结局指标

主要结局

Change from baseline in VAS for pain

时间窗: every 2 weeks. during 6 months

The patients will have a clinical control 6,12 weeks and 6 months postoperatively. The VAS will be registered every 2 weeks via SMS during 6 months

Change from baseline in VAS for pain,

时间窗: 6 weeks, 6 months, and 12 months

次要结局

  • Change from baseline in functionality measured by constant score(6 weeks, 6 months and 12 months)

研究者

发起方
University Hospital of North Norway
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验