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

Degenerative Disc Disease Clinical Trial

— 5R-STS  

Official title:

The Five-repetition Sit-to-stand Test as an Objective Measure of Functional Impairment in Patients With Lower Back Pain or Radiculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03303300
• Other study ID #: 5RSTS
• Status: Completed
• Phase: N/A
• First received: September 23, 2017
• Last updated: December 3, 2017
• Start date: October 1, 2017
• Est. completion date: December 3, 2017

Study information

• Verified date: December 2017
• Source: Bergman Clinics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: December 3, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Degenerative Disc Disease
• Degenerative Spondylolisthesis
• Herniated Disc
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Low Back Pain
• Nerve Root Compress;Lumbosac
• Radiculopathy
• Spinal Stenosis
• Spondylolisthesis
• Stenosis, Spinal

Locations

Country	Name	City	State
Netherlands	Department of Neurosurgery, Bergman Clinics	Naarden

Sponsors (1)

Lead Sponsor	Collaborator
Marc Schröder

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	0 weeks
Secondary	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.	0 weeks
Secondary	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.	0 weeks
Secondary	Oswestry Disability Index	Validated questionnaire (ODI) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.	0 weeks
Secondary	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.	0 weeks