Clinical trial NCT03303300: The Five-repetition Sit-to-stand Test for Lower Back Pain or Radiculopathy
Official title: The Five-repetition Sit-to-stand Test as an Objective Measure of Functional Impairment in Patients With Lower Back Pain or Radiculopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Degenerative Spondylolisthesis
Herniated Disc
Stenosis, Spinal
Nerve Root Compress;Lumbosac
Lead sponsor: Bergman Clinics
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 237
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.


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

Primary outcomes:
measure: 5R-STS
timeFrame: 0 weeks
Secondary outcomes:
measure: VAS back pain
timeFrame: 0 weeks
measure: VAS leg pain
timeFrame: 0 weeks
measure: EQ-5D-3L
timeFrame: 0 weeks
measure: Oswestry Disability Index
timeFrame: 0 weeks
measure: Roland-Morris-Disability Questionnaire
timeFrame: 0 weeks
Other outcomes:
Locations:
city: Naarden
country: Netherlands
facility: Department of Neurosurgery, Bergman Clinics
Study officials:
References:
citation: 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.
citation: 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.