Back Pain5R-STS-IIINCT04660656
Predictive Value of the Five-repetition Sit-to-stand Test After Lumbar Spine surgerySTS-3 Study.
An observational study of Back Pain and Sciatica, run by Bergman Clinics at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- 5 repetition sit-to-stand test
- How many people
- 120 participants
- Where
- 2 sitesNetherlands
- Study dates
- 25 Nov 2020to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: In this study we will collect and analyze the data of 120 patients. Men and woman, all ages.
Who may be able to join
- All patients with lumbar hernias or with 1-level lumbar canal stenoses will be included (consecutive case series).
Who cannot join
- Wheelchair-bound patients, and other patients who cannot walk on their own or are bedridden, as well as pregnant patients, are excluded.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Department of Neurosurgery, Bergman Clinics
Naarden, 1411 GE
Bergman Clinics
Naarden, GE
About this study
Official title: 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.
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.
Read the detailed 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?
- Being tested
- 5 repetition sit-to-stand test
- Medical subject headings
- Back Pain, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 repetition sit-to-stand testDiagnostic test
The sit-to-stand test with five repetitive movements is used as standard in our clinical routine to determine the patient's mobility objectively. The first measurement is performed preoperatively during surgery (baseline). The follow-up measurement is performed six weeks after the operation and one year after the operation in the clinic.
A stool with a fixed height is used for this purpose. The patient should cross his arms over the chest and then slowly stand up until the knees are full of space. Then the patient sits down again, of course without support of the arms. The duration of the five movements is recorded using a stopwatch. The complete movement starts after the "Go" command and ends when the patient is fully upright after the fifth movement. This duration is written down as the patient's score.
What is being measured
The primary outcome is the main question the study is designed to answer.
5R-STS
The test time of the five-repetition sit-to-stand test (5R-STS) measures 12 months after surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start25 Nov 2020
- Primary completion1 Apr 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bergman Clinics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Schröder, Bergman Clinics
- Investigators
- Marc L Schröder, MD, Principal investigator, Bergman Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660656
- Sponsor's protocol ID
- W20.272
- Acronym
- 5R-STS-III
- Status last verified
- Dec 2020
- First submitted
- 1 Dec 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04660656
- Acronym / sponsor ID
- 5R-STS-III / W20.272
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bergman ClinicsUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- In this study we will collect and analyze the data of 120 patients. Men and woman, all ages.
Key inclusion criteria (1 listed)
- All patients with lumbar hernias or with 1-level lumbar canal stenoses will be included (consecutive case series).
Key exclusion criteria (1 listed)
- Wheelchair-bound patients, and other patients who cannot walk on their own or are bedridden, as well as pregnant patients, are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 repetition sit-to-stand testThe sit-to-stand test with five repetitive movements is used as standard in our clinical routine to determine the patient's mobility objectively. The first measurement is performed preoperatively during surgery (baseline). The follow-up measurement is performed six weeks after the operation and one year after the operation in the clinic. A stool with a fixed height is used for this purpose. The patient should cross his arms over the chest and then slowly stand up until the knees are full of space. Then the patient sits down again, of course without support of the arms. The duration of the five movements is recorded using a stopwatch. The complete movement starts after the "Go" command and ends when the patient is fully upright after the fifth movement. This duration is written down as the patient's score. | Diagnostic test | – |
Primary outcome
5R-STS
Time frame: 1 year
The test time of the five-repetition sit-to-stand test (5R-STS) measures 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- The five-repetition sit-to-stand test: evaluation of a simple and objective tool for the assessment of degenerative pathologies of the lumbar spine.Link provided by the sponsor.
- Can objective functional impairment in lumbar degenerative disease be reliably assessed at home using the five-repetition sit-to-stand test?Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc L Schröder, MD principal investigator
Bergman Clinics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain and Sciatica, run by Bergman Clinics at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5R-STS (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.