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临床试验/NCT04660656
NCT04660656Unknown不适用

Investigation of the Predictive Value of the Five-repetition Sit-to-stand Test (5R-STS) on the Outcome of Lumbar Back Surgery. The 5R-STS-III Study.

Bergman Clinics2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年11月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
2
主要终点
5R-STS

研究概览

简要总结

Sciatica is a disabling condition that affects many people. This condition has an enormous influence on the social functioning of patients. The clinical determination of the severity of back pain is mainly done with validated questionnaires, which express the subjective pattern of complaints in a score. These usually reflect the severity of the complaints, but there is still a lack of objective and quantitative tests.

In this study, the aim is to investigate whether there is a connection between the duration of the 5R-STS test and the outcome of low back operations after one year. In other words: What is the predictive value of this test on the result of surgery?

The validated five-repetition sit-to-stand test (5R-STS) is a standardized test that has its origin in pneumology and is derived from the 1-minute sit-to-stand test. In this test, the patient stands up and sits down for 1 minute as often as possible from a chair without armrests, counting the number of movements. This not only measures how mobile the patient is, but can also say something about the condition of the heart and lungs. Recently, the 5R-STS has been described, in which the time is measured in which the patient has to stand up straight and sit down again five times from a chair.

详细描述

Sciatica is a disabling condition that affects many people. This condition has an enormous influence on the social functioning of patients. The clinical determination of the severity of back pain is mainly done with validated questionnaires, which express the subjective pattern of complaints in a score. These usually reflect the severity of the complaints, but there is still a lack of objective and quantitative tests.

Objective functional tests are tests in which the patient has to perform a prescribed procedure or movement while the duration of that movement is then registered. Such tests are already widely used in pneumology and cardiology, but not yet in spine surgery. So far, there are only a few objective tests for functional impairment in back pain such as the 6-minute walking test and timed-up-and-go test.

The validated five-repetition sit-to-stand test (5R-STS) is a standardized test that has its origin in pneumology and is derived from the 1-minute sit-to-stand test. In this test, the patient stands up and sits down for 1 minute as often as possible from a chair without armrests, counting the number of movements. This not only measures how mobile the patient is, but can also say something about the condition of the heart and lungs. Recently, the 5R-STS has been described, in which the time is measured in which the patient has to stand up straight and sit down again five times from a chair.

In spine disorders the 5R-STS had not yet been validated. In 2018, a research group formally validated this test for the first time in patients with lumbar hernia, lumbar canal stenosis, and degenerative spondylolisthesis.1 In this study (5R-STS-I)1 it was concluded that the 5R-STS provides additional information that the simple patient-reported outcome measures (PROMs, questionnaires) cannot demonstrate. It became clear that especially in patients with lumbar hernias two different patient groups existed, namely those with objective functional impairment (OFI) and those without OFI. This subdivision into two groups was even maintained after correction for pain levels. In a follow-up study (5R-STS-II)2 it was shown that when patients undergo the test without supervision - prior to surgery - the test results are equal.

In this study, the investigators want to assess whether there is a connection between the duration of the 5R-STS test and the outcome of low back operations after one year. In other words: What is the predictive value of this test on the result of surgery?

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients with lumbar hernias or with 1-level lumbar canal stenoses will be included (consecutive case series).

排除标准

  • Wheelchair-bound patients, and other patients who cannot walk on their own or are bedridden, as well as pregnant patients, are excluded.

结局指标

主要结局

5R-STS

时间窗: 1 year

The test time of the five-repetition sit-to-stand test (5R-STS) measures 12 months after surgery

次要结局

未报告次要终点

研究者

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

Marc Schröder

Dr. M.L.J.F Schröder

Bergman Clinics

研究点 (2)

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