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临床试验/NCT05937997
NCT05937997已完成不适用

Evaluation and Timing in an ERAS-like Structured Rehabilitation Program After Lumbar Spine Surgery

Median1 个研究点 分布在 1 个国家目标入组 245 人开始时间: 2014年12月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
245
试验地点
1
主要终点
Change of Oswestry Disability Index

研究概览

简要总结

The goal of this clinical trial is to investigate the safety of early inpatient rehabilitation after lumbar spine surgery.

Participants are assigned to therapy groups C (low) - A (high) intensity and receive standardized multimodal rehabilitation for 3 weeks. Groups are compared in terms of safety, disability impairment as well as pain. Timing of rehabilitation is considered.

详细描述

Purpose Literature on early rehabilitation after lumbar spine surgery trends towards a structurized program beginning in the post-acute phase, but publications are rare. Therefore, this study was conducted to investigate the safety of early rehabilitation according to ERAS® principles after different lumbar spine surgeries with regard to training intensity and timing of rehabilitation.

Methods Study design was prospective, non-randomized, and multicentric (3 inpatient rehabilitation facilities in Germany). Based on the senior rehabilitation physician's assessment for patient's physical capacity, patients were assigned to therapy groups C - A (low - high intensity). For statistical analysis patients were also grouped in 3 different time intervals depending on days past surgery until rehabilitation start and. Safety (recurrence rates), disability (Oswestry Disability Index (ODI)), and pain (Visual Analogue Scale (VAS)), were measured at the beginning and at the end of rehabilitation stay. Scores were compared between 3 therapy groups and 3 time intervals for within- and between-group differences. Analgesics and back orthesis use was assessed and analysed as well.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • all patients admitted to inpatient rehabilitation facility after lumbar spine surgery

排除标准

  • non-German speakers

结局指标

主要结局

Change of Oswestry Disability Index

时间窗: at admission to rehabilitation clinic and at about 3 weeks at discharge

Questionnaire with 10 items to evaluate the disability from back pain, results presented in precentage with 0 % experiencing no disability because of back issues and with 100 % experiencing the most disability because of back issues

次要结局

  • Change of Visual Analogue Scale(at admission to rehabilitation clinic and at about 3 weeks at discharge)
  • Recurrence rate(at admission to rehabilitation clinic and at about 3 weeks at discharge)

研究者

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

Johannes Schroeter

Dr. med. Johannes Schroeter

Median

研究点 (1)

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