跳至主要内容
临床试验/NCT05886296
NCT05886296招募中不适用

Evaluation of the Impact of a Pre-surgical Information Session for People Who Must Undergo Shoulder Rotator Cuff Surgery on Empowerment for Their Functional Rehabilitation Process.

Consorci Sanitari de Terrassa1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
54
试验地点
1
主要终点
Shoulder Functionality

研究概览

简要总结

The shoulder is the most mobile joint in the human body. Movements are carried out in most of the activities we participate in, such as work, sports, household tasks, shopping and leisure activities. Shoulder diseases affect 21% of the western population and is one of the most frequent reasons for consultation in orthopedics and rehabilitation consultations.

Shoulder pain is in a large majority of cases related to the slope of the acromion and rotator cuff pathology, which would include the slope of the acromion syndrome. The degree of involvement can range from bursitis, tendinitis, to tendinous ruptures.

Initial treatment is usually conservative and may consist of anti-inflammatory medication and rehabilitation. When the pain is not relieved, surgery is usually recommended. Surgery for rotator cuff tears is increasingly performed minimally invasive, using arthroscopy.

Hospital admission days are currently being reduced, so many of the scheduled shoulder surgeries are performed via the Outpatient Surgery Unit. Often, users are not seen again by the surgeon until a week after the intervention. The affected person must empower themselves and participate actively and progressively in their recovery process. This process begins right after the surgical intervention. Therefore, it is very important that the person has all the necessary information about the surgical procedure that has been performed. Patient education is crucial to reduce anxiety and optimize surgical outcomes.

详细描述

This is a randomized clinical trial with an intervention group (IG) and a control group (CG). As participants are visited by orthopedic surgery, they are referred to rehabilitation. Once in rehabilitation and in order of arrival of the rehabilitation requests, the participants will be randomized into groups of 8 people/week in the IG and the CG. The first group of 8 people will be IG and the following week the second group of 8 people will be CG and so on until reaching the required sample.

The intervention will take place at the Rehabilitation Unit of the Consorci Sanitari de Terrassa

Participants will be anonymized and randomized into two groups: IG and CG. All participants will receive detailed information about the surgical procedure to which they will be subjected during the pre-surgical visit, carried out by the doctor specializing in orthopedic surgery. The information received will include risks and benefits and all participants will be able to ask any questions they may have. The IG will participate in an informational session prior to shoulder surgery. The session aims to: (1) Know the anatomy and functionality of the shoulder, (2) Understand why pain and functional disability appear, (3) Learn what to do to reduce symptoms, (4) Empower people to face the rehabilitation process. The CG will receive the usual rehabilitation protocol at the Consorci Sanitari de Terrassa, which begins three weeks after the surgical intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • People who need shoulder surgery for shoulder rotator cuff pathology
  • Over 18 years old
  • Understand Spanish or Catalan
  • Acceptance of informed consent

排除标准

  • People who have already received previous surgery on the same shoulder
  • People who have had previous infections in the same shoulder
  • Neurological deficits and/or presence of tumors
  • People with visual or cognitive deficits that prevent them from following the information session

结局指标

主要结局

Shoulder Functionality

时间窗: baseline and 12 week

Change of shoulder function from baseline to 12 weeks assessed with Constant Test (Maximum Score is 100 and it means the best function of the shoulder. Minimum Score is 0 and it means the worse function of the shoulder)

次要结局

  • Empowerment(baseline)
  • Participant's satisfaction(12 week)
  • Participants' Quality of Life perception(baseline and 12 week)
  • Shoulder Function(baseline and 12 week)

研究者

发起方
Consorci Sanitari de Terrassa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Montserrat Grau-Pellicer

PhD

Consorci Sanitari de Terrassa

研究点 (1)

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