跳至主要内容
临床试验/NCT07820592
NCT07820592Enrolling By Invitation不适用

Prehabilitation Before Surgery: A Strategy To Accelerate Recovery After Rotator Cuff Repair? A Randomized Pilot Clinical Trial

Laura Castillo Vejar1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年9月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
1
主要终点
Western Ontario Rotator Cuff (WORC)

研究概览

简要总结

A rotator cuff tear is a structural injury to one or more tendons of the rotator cuff, ranging from degenerative changes to partial or complete tears. Rotator cuff tears are among the most common causes of shoulder pain and disability, particularly in middle-aged and older adults, and their prevalence increases with age. Population studies report a prevalence of complete tears around 20% to 22%, while in cohorts of individuals over 70 years of age, it can exceed 50%. The risk of tearing is associated with advanced age, dominant arm involvement, trauma, heavy labor, and male sex.

详细描述

Physiological stress and adverse psychological factors can negatively interfere with postoperative recovery. To address this challenge, prehabilitation emerges as a comprehensive strategy that actively prepares patients before surgery, aiming to improve physical condition, optimize nutritional status, and implement cognitive interventions to reduce stress and anxiety. However, the application of prehabilitation in musculoskeletal injuries remains controversial. The main interventions in musculoskeletal injuries are based on strengthening exercises, balance and proprioceptive work, combined to a lesser extent with preoperative education and the use of neuromuscular electrical stimulation.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men or women
  • Over 50 years of age
  • Awaiting arthroscopic surgery for rotator cuff repair of one or more tendons
  • Signed informed consent.

排除标准

  • Patients with a history of previous shoulder surgery ( in the contralateral shoulder)
  • Patients with a massive irreparable rotator cuff tears
  • Patientes with a history of infiltration in an injured shoulder
  • Uncontrolled or undiagnosed sleep disorders
  • The presence of mental or neurological illness, inability to read or follow instructions.

研究组 & 干预措施

Prehabilitation

Experimental

2 prehabilitation sessions before surgery + standard postoperative ohysiotherapy rehabilitation

干预措施: Prehabilitation (Other)

Control group

No Intervention

Received a standard ohysical therapy program alone, Following arthroscopic surgery, all participants were immobilized with a sling and abduction cushion for 3 weeks. Participants attended physical therapy 2 to 3 times per week, with each session consisting of 60 minutes of intervention. The same exercise protocol based on the consensus guidelines of The American Society of Shoulder and Elbow Therapists was followed.

结局指标

主要结局

Western Ontario Rotator Cuff (WORC)

时间窗: 4,8 and 12 week

It consists of 21 questions, addressing physical symptoms, sports and recreation, work and recreation, work, life studies and emotions. All dimensions were calculated and will be reported as a percentage. The WORC (Western Ontario Rotator Cuff Index) has an absolute maximum score of 2100 points, representing the worst possible symptoms or the highest level of shoulder disability.

次要结局

  • Grip Strength(4,8 and 12 week)
  • Pain intensity(4,8 and 12 week)
  • Kinesiophobia (TSK-11)(4,8 and 12 week)
  • Catastrophizing (PCS)(4,8 and 12 week)
  • Disability (QUICKDASH)(4,8 and 12 week)
  • Mobility (ROM)(4,8 and 12 week)
  • Sleep quality (PSQI)(4,8 and 12 week)

研究者

发起方
Laura Castillo Vejar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Laura Castillo Vejar

Msc

Clinica Redsalud

研究点 (1)

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