跳至主要内容
临床试验/NCT01623011
NCT01623011已完成不适用

What is the Clinical and Cost Effectiveness of Arthroscopic Sub-acromial Decompression Surgery?

University of Oxford2 个研究点 分布在 1 个国家目标入组 313 人开始时间: 2012年9月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
313
试验地点
2
主要终点
Oxford Shoulder Score

研究概览

简要总结

Shoulder problems causing pain and decreased function are very common. Many of these problems are related to the rotator cuff tendons. Shoulder arthroscopy surgery (keyhole surgery) is a common treatment for this pain. This can involve an Arthroscopic Subacromial Decompression (ASAD) an operation used to remove bony spurs which may be the cause of the pain. This procedure is widely used despite limited evidence of any effectiveness. This is a randomised controlled trial that will compare ASAD against an investigational shoulder arthroscopy (without spur removal/decompression) to indicate whether spur removal is really necessary and in turn, assessing the effectiveness of the ASAD procedure. Both surgical interventions are routine and will mirror each other except for the spur removal element. Both treatments will be compared against a control (non operative management with specialist reassessment) group to indicate whether surgery in general is effective for patients with subacromial pain. Patients randomised to either of the surgical options will be blinded to the type of surgery they have. This is a multicentre trial taking place in 10 centres in England and Wales. Two satellite studies will also take place. One will involve a subset of patients undergoing MRI scans to examine the effects of their shoulder pain on their brain transmissions. The other will involve collecting tissue samples from patients undergoing surgery.

详细描述

The prevalence of shoulder complaints in the UK is estimated to be 14%, with 1-2% of adults consulting their general practitioner annually regarding new-onset shoulder pain. Rotator cuff pathology, including rotator cuff tears and sub-acromial pain, reportedly accounts for up to 70% of shoulder pain problems. Other common causes of shoulder pain include frozen shoulder, calcific tendonitis and osteoarthritis (OA).

Painful shoulders pose a substantial socioeconomic burden. Disability of the shoulder can impair ability to work or perform household tasks and can result in time off work. Shoulder problems account for 2.4% of all general practitioner consultations in the UK and 4.5 million visits to physicians annually in the USA. With the exception of fractures and traumatic rotator cuff tears, most shoulder pain problems are treated initially with conservative care. In some patients with persistent symptoms, surgery might be required. More than 300,000 surgical repairs for rotator cuff pathologies are performed annually in the USA, and the annual financial burden of shoulder pain management in the USA has been estimated to be US$3 billion.

Sub-acromial pain is the most frequent cause of shoulder problems in the general population. An anatomical etiology has been proposed, whereby mechanical contact occurs between the rotator cuff tendons and the overlying acromion and coracohumeral ligament. Sub-acromial pain and rotator cuff tears are associated with progressive change in the shape of the acromion, with 'spurs' forming at its antero-inferior margin. Evidence suggests spurs develop which narrow the sub-acromial space, thereby making physical contact more likely, particularly in certain positions of the arm (for example, painful arc), and resulting in inflammation. This is sometimes referred to as "impingement". However this term suggests a definitive mechanism of the pain and conflicting theories indicate such mechanisms are not definitive. For the purposes of this study we will continue to refer to this as "sub-acromial pain".

A high proportion of patients with sub-acromial pain will respond to conservative treatment. The most frequent indications for surgery are persistent and severe pain combined with functional restrictions that are resistant to conservative measures. Despite surgery being considered at this point, some reports show that surgery can be no more effective than physiotherapy in the relief of pain when used in patients at this stage. Surgical intervention can, however, achieve good results and its judicious use seems valid. The most common surgical intervention for sub-acromial pain is a sub-acromial decompression (SAD), which can be performed through an arthroscopic (ASAD) approach. An assessment of the cost of treatment of impingement also suggested that the addition of surgery, in comparison to exercise treatment alone, is not cost-effective.

Further research might identify whether the source of pain is the tendon, the acromion or the bursa, and hence help to rationalize surgical treatment.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sub-acromial pain of at least 3 month (tendinopathy and partial tear only).
  • Diagnosed by a Consultant of tendinopathic pain or partial thickness rotator cuff tear
  • Has had an MRI or Ultrasound Scan to rule out alternative pathology
  • Eligible for surgery.
  • Completed a conservative management programme previously including:
  • physiotherapy that includes a remedial exercise regimen and
  • at least x1 cortisone injection but not more than 3 injections.

排除标准

  • Full thickness tear of the rotator cuff tendons evident on MRI or Ultrasound imaging
  • Undergone previous surgery on affected shoulder
  • Have RA or other inflammatory disorder
  • Symptomatic cervical spine pathology
  • Previous septic arthritis
  • History of radiotherapy on same side as affected shoulder
  • Patients who have a strong preference for one treatment over another to an extent that they would not participate if allocated to their non- preferred group.

结局指标

主要结局

Oxford Shoulder Score

时间窗: 6 months post randomisation

Patient reported outcome measure of shoulder pain and function.

次要结局

  • Constant Murley Shoulder Score(6 and 12 months post randomisation)
  • Pain DeTECT(6 and 12 months post randomisation)
  • Quantitative Sensory Testing(6 and 12 months post randomisation)
  • Health Economics - EQ5D(6 and 12 months post randomisation)
  • Complications(6 and 12 months post randomisation)
  • Oxford Shoulder Score(12 months post randomisation)
  • Treatment Expectations and Satisfaction(6 and 12 months post randomisation)
  • Hospital Anxiety and Depression Scale(6 and 12 months post randomisation)
  • Patient Response Shift(12 months post randomisation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验