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

• Sponsor: Marc Schröder (Other)
• Overall Status: Completed
• CT.gov ID: NCT03303300
• Collaborator: (none)
• Enrollment: 237
• Location: 1
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 114.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Disc Disease; Degenerative Spondylolisthesis; Herniated Disc; Stenosis, Spinal; Nerve Root Compress;Lumbosac

Study Design

• Study Type: Observational
• Actual Enrollment: 237 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Five-repetition Sit-to-stand Test as an Objective Measure of Functional Impairment in Patients With Lower Back Pain or Radiculopathy
• Actual Study Start Date: Oct 1, 2017
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 3, 2017

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurosurgery, Bergman Clinics	Naarden		Netherlands	1411 GE

Sponsors and Collaborators

• Marc Schröder

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marc Schröder, MD, PhD, Bergman Clinics
• ClinicalTrials.gov Identifier: NCT03303300
• Other Study ID Numbers: 5RSTS
• First Posted: Oct 6, 2017
• Last Update Posted: Dec 5, 2017
• Last Verified: Dec 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intervertebral Disc Degeneration; Spondylolisthesis; Intervertebral Disc Displacement; Spinal Stenosis; Radiculopathy; Back Pain; Low Back Pain

Study Results

No Results Posted as of Dec 5, 2017