NCT03303300

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2017

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

2 months

First QC Date

September 23, 2017

Last Update Submit

December 3, 2017

Conditions

Outcome Measures

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".

    0 weeks

Secondary Outcomes (5)

  • VAS back pain

    0 weeks

  • VAS leg pain

    0 weeks

  • EQ-5D-3L

    0 weeks

  • Oswestry Disability Index

    0 weeks

  • Roland-Morris-Disability Questionnaire

    0 weeks

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Hip or Knee prosthetics
  • Walking aides
  • This study will also include 25 healthy volunteers:
  • \- No degenerative spinal or lower extremity complaints
  • Back pain, leg pain, other lower extremity-related complaints
  • Knee or hip prosthetics
  • Walking aides

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Bergman Clinics

Naarden, 1411 GE, Netherlands

Location

Related Publications (3)

  • Klukowska 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Intervertebral Disc DegenerationIntervertebral Disc DisplacementSpinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 23, 2017

First Posted

October 6, 2017

Study Start

October 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 3, 2017

Last Updated

December 5, 2017

Record last verified: 2017-12

Locations