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CompletedNCT033033005R-STSUpdated Dec 5, 2017

The Five-repetition Sit-to-stand Test for Lower Back Pain or Radiculopathy

An observational study in Degenerative Disc Disease, Degenerative Spondylolisthesis and Herniated Disc, sponsored by Marc Schröder. Completed at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2017-12-05.

Sponsored by Marc Schröder · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
237
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Degenerative Disc Disease
  • Degenerative Spondylolisthesis
  • Herniated Disc
  • Stenosis, Spinal
  • Nerve Root Compress;Lumbosac
03

In context

Intervertebral Disc Degeneration

462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.

This study's enrollment of 237 is above the median of 119 across 170 observational studies indexed under Intervertebral Disc Degeneration.

Browse Intervertebral Disc Degeneration studies →

Lead sponsor

Marc Schröder is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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

Eligibility criteria

This study will include 100 Patients:

Inclusion Criteria:

  • Degenerative diseases of the lumbar spine (Herniated disc, lumbar stenosis, spondylolisthesis, degenerative disc disease)
  • Symptoms of lower back pain, neurogenic claudication, or radiculopathy

Exclusion Criteria:

  • Hip or Knee prosthetics
  • Walking aides

This study will also include 25 healthy volunteers:

Inclusion Criteria:

  • No degenerative spinal or lower extremity complaints

Exclusion Criteria:

  • Back pain, leg pain, other lower extremity-related complaints
  • Knee or hip prosthetics
  • Walking aides
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
237 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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".

    Time frame: 0 weeks

Secondary outcomes

  1. 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.

    Time frame: 0 weeks

  2. 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.

    Time frame: 0 weeks

  3. 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.

    Time frame: 0 weeks

  4. Oswestry Disability Index

    Validated questionnaire (ODI) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.

    Time frame: 0 weeks

  5. 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.

    Time frame: 0 weeks

07

Study locations

1 site
  • Department of Neurosurgery, Bergman Clinics
    Naarden, 1411 GE, Netherlands
08

References and documents

Publications

  • Staartjes 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 31451936 ↗
  • Staartjes 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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Dec 2017, 2 months.

Of 80 observational studies under Intervertebral Disc Degeneration, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 84. This study's 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2017
First posted
Oct 6, 2017
StartActual
Oct 1, 2017
Primary completionActual
Dec 1, 2017
CompletionActual
Dec 3, 2017
Last update
Dec 5, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03303300
Lead sponsor
Marc Schröder
Responsible party
Marc Schröder (MD, PhD, Bergman Clinics) — Sponsor-investigator
First posted
Oct 6, 2017
Start date
Oct 1, 2017
Primary completion
Dec 1, 2017
Completion
Dec 3, 2017
Last update
Dec 5, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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