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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03303300
Other study ID # 5RSTS
Secondary ID
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
Health authority
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

Study Design


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
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