Degenerative Disc Disease5R-STSNCT03303300
The Five-repetition Sit-to-stand Test for Lower Back Pain or Radiculopathy
An observational study of Degenerative Disc Disease and Degenerative Spondylolisthesis, run by Marc Schröder at 1 site in Netherlands.
Trial summary
The five-repetition sit-to-stand test (5R-STS) has been used in many medical disciplines, but has never been correlated with or validated in regard to degenerative spinal diseases. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Herniated Disc
- How many people
- 237 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2017to 3 Dec 2017
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 100 patients with degenerative lumbar spinal diseases that are seen in outpatient consultations will be recruited. All tests and questionnaires are part of the normal clinical assessment of the study center; The patients are thus not required to make any extra efforts. 25 healthy volunteers (the authors and volunteers from the department) will be included to get baseline data for the 5R-STS in healthy people
Who may be able to join
- Degenerative diseases of the lumbar spine (Herniated disc, lumbar stenosis, spondylolisthesis, degenerative disc disease)
- Symptoms of lower back pain, neurogenic claudication, or radiculopathy
- No degenerative spinal or lower extremity complaints
Who cannot join
- Hip or Knee prosthetics
- Walking aides
- This study will also include 25 healthy volunteers:
- Back pain, leg pain, other lower extremity-related complaints
- Knee or hip prosthetics
- Walking aides
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Neurosurgery, Bergman Clinics
Naarden, 1411 GE
About this study
Official title: The Five-repetition Sit-to-stand Test as an Objective Measure of Functional Impairment in Patients With Lower Back Pain or Radiculopathy
The five-repetition sit-to-stand test (5R-STS) has been used in many medical disciplines, but has never been correlated with or validated in regard to degenerative spinal diseases. The investigators aim to assess the possibility of using the standardized 5R-STS as an objective measure of functional impairment and pain severity in patients with degenerative lumbar spinal diseases.
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Herniated Disc, Stenosis, Spinal, Nerve Root Compress;Lumbosac
- Medical subject headings
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
5R-STS
The result of the standardized 5R-STS in seconds. If the patient is unable to complete the test, the results is noted as "not possible".
Measured: 0 weeks
Secondary outcomes (5)
VAS back pain
Validated questionnaire (VAS BP) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.
Measured: 0 weeks
VAS leg pain
Validated questionnaire (VAS LP) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.
Measured: 0 weeks
EQ-5D-3L
Validated questionnaire (EQ-5D-3L) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.
Measured: 0 weeks
Oswestry Disability Index
Validated questionnaire (ODI) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.
Measured: 0 weeks
Roland-Morris-Disability Questionnaire
Validated questionnaire (RMDBQ) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.
Measured: 0 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start1 Oct 2017
- Primary completion1 Dec 2017
- Study completion3 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marc Schröder
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marc Schröder, Bergman Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303300
- Sponsor's protocol ID
- 5RSTS
- Acronym
- 5R-STS
- Status last verified
- Dec 2017
- First submitted
- 23 Sep 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Staartjes VE, Klukowska AM, Stumpo V, Vandertop WP, Schroder ML. Identifying clusters of objective functional impairment in patients with degenerative lumbar spinal disease using unsupervised learning. Eur Spine J. 2024 Apr;33(4):1320-1331. doi: 10.1007/s00586-023-08070-z. Epub 2023 Dec 21.
PubMed 38127138Klukowska AM, Staartjes VE, Vandertop WP, Schroder ML. Predictors of five-repetition sit-to-stand test performance in patients with lumbar degenerative disease. Acta Neurochir (Wien). 2023 Jan;165(1):107-115. doi: 10.1007/s00701-022-05441-1. Epub 2022 Dec 7.
PubMed 36477416Staartjes VE, Klukowska AM, Schroder ML. Association of maximum back and leg pain severity with objective functional impairment as assessed by five-repetition sit-to-stand testing: analysis of two prospective studies. Neurosurg Rev. 2020 Oct;43(5):1331-1338. doi: 10.1007/s10143-019-01168-3. Epub 2019 Aug 26.
PubMed 31451936Staartjes VE, Schroder ML. The five-repetition sit-to-stand test: evaluation of a simple and objective tool for the assessment of degenerative pathologies of the lumbar spine. J Neurosurg Spine. 2018 Oct;29(4):380-387. doi: 10.3171/2018.2.SPINE171416. Epub 2018 Jun 29.
PubMed 29957147
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Five-repetition Sit-to-stand Test as an Objective Measure of Functional Impairment in Patients With Lower Back Pain or Radiculopathy
- ClinicalTrials.gov ID
- NCT03303300
- Acronym / sponsor ID
- 5R-STS / 5RSTS
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Herniated Disc, Stenosis, Spinal, Nerve Root Compress;Lumbosac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Marc SchröderUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 3 Dec 2017 (actual)
- First posted
- 6 Oct 2017 (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.
The five-repetition sit-to-stand test (5R-STS) has been used in many medical disciplines, but has never been correlated with or validated in regard to degenerative spinal diseases. The investigators aim to assess the possibility of using the standardized 5R-STS as an objective measure of functional impairment and pain severity in patients with degenerative lumbar spinal diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 100 patients with degenerative lumbar spinal diseases that are seen in outpatient consultations will be recruited. All tests and questionnaires are part of the normal clinical assessment of the study center; The patients are thus not required to make any extra efforts. 25 healthy volunteers (the authors and volunteers from the department) will be included to get baseline data for the 5R-STS in healthy people
Key inclusion criteria (3 listed)
- Degenerative diseases of the lumbar spine (Herniated disc, lumbar stenosis, spondylolisthesis, degenerative disc disease)
- Symptoms of lower back pain, neurogenic claudication, or radiculopathy
- No degenerative spinal or lower extremity complaints
Key exclusion criteria (6 listed)
- Hip or Knee prosthetics
- Walking aides
- Back pain, leg pain, other lower extremity-related complaints
- Knee or hip prosthetics
- Walking aides
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
5R-STS
Time frame: 0 weeks
The result of the standardized 5R-STS in seconds. If the patient is unable to complete the test, the results is noted as "not possible".
5 secondary outcomes
VAS back pain
Time frame: 0 weeks
VAS leg pain
Time frame: 0 weeks
EQ-5D-3L
Time frame: 0 weeks
Oswestry Disability Index
Time frame: 0 weeks
Roland-Morris-Disability Questionnaire
Time frame: 0 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Derived from this study: PubMed 38127138Staartjes VE, Klukowska AM, Stumpo V, Vandertop WP, Schroder ML. Identifying clusters of objective functional impairment in patients with degenerative lumbar spinal disease using unsupervised learning. Eur Spine J. 2024 Apr;33(4):1320-1331. doi: 10.1007/s00586-023-08070-z. Epub 2023 Dec 21.
- Derived from this study: PubMed 36477416Klukowska AM, Staartjes VE, Vandertop WP, Schroder ML. Predictors of five-repetition sit-to-stand test performance in patients with lumbar degenerative disease. Acta Neurochir (Wien). 2023 Jan;165(1):107-115. doi: 10.1007/s00701-022-05441-1. Epub 2022 Dec 7.
- Derived from this study: PubMed 31451936Staartjes VE, Klukowska AM, Schroder ML. Association of maximum back and leg pain severity with objective functional impairment as assessed by five-repetition sit-to-stand testing: analysis of two prospective studies. Neurosurg Rev. 2020 Oct;43(5):1331-1338. doi: 10.1007/s10143-019-01168-3. Epub 2019 Aug 26.
- Derived from this study: PubMed 29957147Staartjes VE, Schroder ML. The five-repetition sit-to-stand test: evaluation of a simple and objective tool for the assessment of degenerative pathologies of the lumbar spine. J Neurosurg Spine. 2018 Oct;29(4):380-387. doi: 10.3171/2018.2.SPINE171416. Epub 2018 Jun 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Degenerative Spondylolisthesis, run by Marc Schröder at 1 site 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 0 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03303300, which also lists 4 linked publications.
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 5 Dec 2017.