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临床试验/NCT01506804
NCT01506804已完成不适用

The Efficacy of Exercise Therapy Followed by Ultrasound Guided Injection in Patients With a Painful Shoulder - a Randomised Controlled Study With Blinded Observer

Frederiksberg University Hospital1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2010年11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
99
试验地点
1
主要终点
Pain in the shoulder in both rest and motion (VAS)

研究概览

简要总结

Many patients experience an effect of steroid injection, however the effect is often short lasting and recurrence of symptoms is common. The short term effect of injection has been shown to be much better than exercise therapy; however over time the superior effect of injection compared to exercise does not last. Injection in combination with exercise therapy might be a more sufficient therapy than injection alone. The aim of this study is to investigate a combination of steroid injection and a 10 week exercise program. In addition, the study tests the validity of clinical impingement tests using ultrasound verified impingement as gold standard.

详细描述

For many patients unspecific pain and reduced motion in the shoulder is a common complaint. It is believed that the main reason for shoulder pain comes from inflammation of the bursa.

Many patients experience an effect of steroid injection, however the effect is often short lasting and recurrence of symptoms is common. Exercise therapy for the muscles around the shoulder joint is also common treatment for shoulder pain. The short term effect of injection has been shown to be much better than exercise therapy; however over time the superior effect of injection compared to exercise does not last. The anti-inflammatory and pain releasing effect of steroid injection in combination with exercise therapy increasing the strength and control of the muscles around the shoulder joint, might be a more sufficient therapy than injection alone. Thus, the aim of this study is to investigate a combination of steroid injection and a 10 week exercise program in patients with a painful shoulder.

Many different clinical tests are used to examine the pathological compression of the bursa during motion in the shoulder joint (impingement). However, it is actually not known if the pain in motion is caused by compression of the bursa. Part of this study therefore is to test the validity of clinical impingement tests using ultrasound verified impingement as gold standard.

Studies comparing injection given guided by ultrasound to blind injections have shown that the ultrasound guided injections are more likely to place the active stuff correctly in the swollen bursa. In this study all injections will be given ultrasound guided. In the ultrasound examination the thickness of the bursa will be measured in all patients in order to investigate if swollenness of the bursa can explained the pain and dysfunction of the shoulder joint

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Pain and reduced motion in the shoulder for more than four weeks
  • •Ultrasound verified swollenness of the bursa.

排除标准

  • •Bilateral pain in the shoulder joints
  • •Rupture of the rotator cuff or biceps tendons
  • •Generalised disease which can explain the shoulder pain
  • •OA in the shoulder joint
  • •Positive compression test of the cervical spine

研究组 & 干预措施

Contralateral training

Placebo Comparator

Steroid injection X 2 and 10 weeks exercise program of asymptomatic shoulder

干预措施: methylprednisolone (Other)

Training of painful shoulder

Experimental

Steroid injection X 2 and 10 weeks exercise program of painful shoulder

干预措施: methylprednisolone (Other)

结局指标

主要结局

Pain in the shoulder in both rest and motion (VAS)

时间窗: 6 months

次要结局

  • Ultrasound(6 months)
  • Strength(6 months)
  • Clinical impingement(6 months)
  • Shoulder function(6 months)

研究者

发起方
Frederiksberg University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Henning Bliddal

Professor

Frederiksberg University Hospital

研究点 (1)

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