Influence of Pre-operative Back Muscle Exercise on Post-operative Outcomes After Spine Surgery
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:
- Pre-habilitation treatment arm
- 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
- 否
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
Bahar Shahidi
Associate Professor
University of California, San Diego
