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临床试验/NCT06808022
NCT06808022Enrolling By Invitation不适用

Influence of Pre-operative Back Muscle Exercise on Post-operative Outcomes After Spine Surgery

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年2月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
70
试验地点
2
主要终点
Surgical Revision

研究概览

简要总结

The purpose of this research study is to gather more information about how improving back muscle function before surgery might influence what happens to the spine and function after surgery. This may assist in developing ways to improve surgical outcomes and determine the benefit of pre-operative exercise, if any.

详细描述

The investigators intend to enroll patients from UCSD spine clinic. The investigators will include patients who are indicated for a spine surgery. Once participants are identified to be surgical candidates, and have an estimated surgical date that is 4-6 weeks from identification, the participants may undergo pre-operative procedures including a pre-operative evaluation and treatment by a physical therapist, data collection (demographics, medical history, etc.), and filling out relevant questionnaires. Patients will undergo their surgery as scheduled with the spine surgeon as part of their planned standard care unless the surgeon decides that the surgery is no longer necessary. Participation in research does not influence the surgeon's decision. Post-operatively, participants may be asked to undergo a post-operative evaluation and fill out questionnaires.

Upon identification of eligibility, participants may be randomized to one of two study arms using a random number generator. If group characteristics are observed to be unbalanced using this approach, participants may be matched according to demographic or surgical features:

  1. Pre-habilitation treatment arm
  2. Standard of Care arm Participants in the standard of care arm will undergo all pre-operative activities recommended by their surgeon as per standard care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • - Individuals undergoing spinal surgery
  • Individuals who have been deemed medically safe to participate in an exercise-based physical therapy program

排除标准

  • - Individuals with comorbid conditions or spinal injury inappropriate for participating in an exercise-based physical therapy program as determined by the surgeon (e.g. unstable vertebral fracture)
  • Individuals that do not have the ability to commit to the therapy schedule either in-clinic or using the web-based interface
  • Non-english speaking individuals (some questionnaires are validated only in English)

结局指标

主要结局

Surgical Revision

时间窗: 1 year

Patient requires surgical revision within 1 year of index surgery

次要结局

  • Length of stay(3 months)
  • Numeric Pain Rating Scale(1 year)
  • Disability(1 year)

研究者

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

Bahar Shahidi

Associate Professor

University of California, San Diego

研究点 (2)

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