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临床试验/NCT02631486
NCT02631486已完成不适用

Does Early Mobilisation After Surgical Repair of Rotator Cuff Tears Improve Biomechanical and Clinical Outcomes?

University of Central Lancashire2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change from baseline range of motion

研究概览

简要总结

Shoulder pain is among the most common musculoskeletal complaints, leading to high number of General Practioners consultations in the United Kingdom. On the top list of the disorders causing pain and dysfunction of shoulder is rotator cuff tears. The aetiology of rotator cuff tears is multifactorial and is likely to be a combination of age-related degenerative changes and trauma during life. It is present in approximately 25% of individuals in their 60s and 50% of individuals in their 80s and have been shown to start developing during the 40s. To recover functional status of this patients group, surgical repair is often recommended, but for optimal results the rehabilitation is of great importance and must be adequately planned. After surgery a period of movement restriction is followed, however, the optimal time of immobilisation is unknown. As a common practice, patients use a sling for six weeks and avoid any activities with the affected shoulder. This period is important to protect the tendon, allow good healing and to possibly prevent re-tear episodes. Although, the delayed motion may increase the risk of postoperative shoulder stiffness, muscle atrophy and potentially delay improvement of functionality. Based on the available evidence, it is difficult to make a clinical decision for a well-programmed rehabilitation regime and establish the most favourable postoperative time to start it. Moreover, it is not clear if early mobilisation will benefit more severe stages as published studies have methodological flaws that compromises the clinical decision for patients with higher commitments. The question whether early mobilisation application is beneficial is of high importance as the results will not just help improving patients quality of life, but also may reduce costs as further complication may be avoided.

详细描述

The study will be a randomised controlled trial, which means that each participant will have equal chances to be assigned to one of 2 groups.

The first group will start the rehabilitation after 3 weeks post-surgery and the second group will start after 6 weeks.

The rehabilitation stages will start with passive movements, progressing to more active stages phases until full recovery. The whole program will last about 3 months, which is in accordance to what is normally used at the Wrightington Hospital.

Each participant will have 4 assessment sessions: 1 pre-surgery, after 3 months post-surgery, after 6 months and the last after 12 months post-surgery.

The assessment sessions will consist on answering questionnaires and a clinical assessment with equipment, which measures muscle activity and joint angles during clinical tasks.

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

入选标准

  • Age between 40 and 70 years old,
  • Confirmed diagnosis of rotator cuff tear
  • No previous shoulder surgery
  • No other musculoskeletal impairment in the assessed limb or cervical and thoracic spine.

排除标准

  • Previous shoulder surgery
  • Fixation which does not allow early mobilisation
  • Other musculoskeletal impairment in the assessed limb or cervical and thoracic spine,
  • People with special needs who are unable to understand the instructions needed,
  • Non-English or non-Portuguese speakers.

研究组 & 干预措施

Early

Experimental

The first group will use sling for comfort only. Active assisted exercises in closed chain and in safe zone are allowed in the first 4 weeks.

The rehabilitation stages will start from active assisted progressing to more active stages phases until full recovery. The whole program will last about 3 months.

干预措施: Physiotherapy (Other)

Conservative

Active Comparator

The second group will use a sling for 6 weeks. The rehabilitation stages will start with active assisted/closed chain movements with short levers, it will progress to more active stages phases until full recovery. The whole program will last about 3 months.

干预措施: Physiotherapy (Other)

结局指标

主要结局

Change from baseline range of motion

时间窗: Pre-surgery (baseline), change from baseline range of motion at 3 months, change from baseline range of motion at 6 months, change from baseline range of motion at 1 year

次要结局

  • Change from baseline muscle activity in millivolts(Pre-surgery (baseline), change from baseline range of motion at 3 months, change from baseline range of motion at 6 months, change from baseline range of motion at 1 year)
  • Re-tears ratio(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruno Fles Mazuquin

Mr

University of Central Lancashire

研究点 (2)

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