跳至主要内容
临床试验/NCT07135375
NCT07135375进行中(未招募)不适用

"Prehabilitation as a Predictor of Functional Success Following Rotator Cuff Repair: A Pilot Randomized Controlled Trial".

LAURA CASTILLO VEJAR2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
试验地点
2
主要终点
Functionality

研究概览

简要总结

Rotator cuff injuries are the third leasing cause of pain and disability, accounting for 16% of all musculoskeletal injuries. Following surgical intervention, patients typically undergo a 4 to 6 week immobilization period before starting physical therapy. This rehabilitation phase can last between 4 to 6 months. Despite this, there is currently a lack of clear guidelines regarding specific physical therapy protocols or the expected post surgical recovery for patients who have undergone rotator cuff repair.

详细描述

Objective

Evaluate the impact of a PNE-based prehabilitation program on early and medium-term functional recovery trajectories, pain intensity, and psychosocial factors following RCR. Additionally, it investigates the role of baseline psychosocial variables and prehabilitation exposure as independent predictors of post-operative functional success at 12 weeks.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • •People over 50 years of age
  • •People have undergone arthroscopic rotator cuff of one or more tendons.
  • •Patients must sign informed consent and undergo physical therapy center (up to week 12 postoperatively).

排除标准

  • •Patients who develop postoperative stiffness or adhesive capsulitis during the rehabilitation process.
  • •Patients with symptoms of cervical radiculopathy or previously diagnosed sleep disorders.
  • •Patients with neurological or cognitive disorders who have difficulty following instructions

研究组 & 干预措施

Prehabilitation

Experimental

Prehabilitation + standart rehabilitation

干预措施: Rehabilitation protocol (Other)

Standard protocol

Active Comparator

According American Society of Shoulder and elbow therapist

干预措施: Rehabilitation protocol (Other)

结局指标

主要结局

Functionality

时间窗: 3,6,9 and 12 weeks postoperatively

QuickDash questionnaire will be administered, which provides information on the level of shoulder disability. The results of this questionnaire are reported as a percentage ranging from 0 to 100%. The higher the score, the greater the level of disability.

Pain nocturnal, dynamic and static

时间窗: 3,6,9 and 12 weeks postoperatively

Numeric visual scale, considering 0 as no pian and 10 as the maximum perceived pain. The patient will be asked about his pain at rest, movement, and at night.

Sleep quality

时间窗: 3,6,9 and 12 weeks postoperatively

Subjective perception of sleep quality was assessed through questions regarding hours of sleep, number of times awakened due to pain, and use of medication to control nigth time sleep.

次要结局

  • Range of movility(3,6,9 and 12 weeks postoperatively)

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

Sponsor- Principal investigador, Physiotherapist

TRIMEDKINE

研究点 (2)

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