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

Completed

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

• Registration Number: NCT03303300
• Lead Sponsor: Marc Schröder

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-23
• Study Start: 2017-10-01
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-06
• Status Verified: 2017-12
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-03
• Last Update Submitted: 2017-12-03
• Last Update Posted: 2017-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5R-STS	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".

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Neurosurgery, Bergman Clinics; 🇳🇱 Naarden, Netherlands