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Completed

NCT Number: NCT03303300

The Five-repetition Sit-to-stand Test for 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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Degenerative Spondylolisthesis Hernia Herniated Disc Intervertebral Disc Degeneration Intervertebral Disc Displacement Musculoskeletal Diseases Nerve Root Compress;Lumbosac Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases Spinal Stenosis Stenosis, Spinal

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurosurgery, Bergman Clinics

Naarden, 1411 GE, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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".

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Marc Schröder

Other

Registry information

Official study title

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

Acronym: 5R-STS

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 6, 2017
Registry last updated
Dec 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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