The Five-repetition Sit-to-stand Test for Lower Back Pain or Radiculopathy (5R-STS)

December 3, 2017 updated by: Marc Schröder

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

237

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Naarden, Netherlands, 1411 GE
        • Department of Neurosurgery, Bergman Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
0 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS back pain
Time Frame: 0 weeks
Validated questionnaire (VAS BP) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.
0 weeks
VAS leg pain
Time Frame: 0 weeks
Validated questionnaire (VAS LP) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.
0 weeks
EQ-5D-3L
Time Frame: 0 weeks
Validated questionnaire (EQ-5D-3L) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.
0 weeks
Oswestry Disability Index
Time Frame: 0 weeks
Validated questionnaire (ODI) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.
0 weeks
Roland-Morris-Disability Questionnaire
Time Frame: 0 weeks
Validated questionnaire (RMDBQ) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.
0 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marc Schröder

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 3, 2017

Study Registration Dates

First Submitted

September 23, 2017

First Submitted That Met QC Criteria

October 4, 2017

First Posted (Actual)

October 6, 2017

Study Record Updates

Last Update Posted (Actual)

December 5, 2017

Last Update Submitted That Met QC Criteria

December 3, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5RSTS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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