Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04660656 |
| Other study ID # |
W20.272 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 25, 2020 |
| Est. completion date |
May 1, 2022 |
Study information
| Verified date |
December 2020 |
| Source |
Bergman Clinics |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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?
