Status:
COMPLETED
The Six-Minute Walking Test (6WT) and Timed-Up-and-Go (TUG) Test as Measures of Objective Functional Impairment in Patients Undergoing Interlaminar or Transforaminal Epidural Steroid Injection for Lumbar Degenerative Disc Disease (DDD)
Lead Sponsor:
Cantonal Hospital of St. Gallen
Collaborating Sponsors:
PD Dr. med. Martin Stienen, Klinik für Neurochirurgie, Universitätsspital Zürich
PD Dr. med. David Bellut, Klinik für Neurochirurgie, Universitätsspital Zürich
Conditions:
Lumbar Disc Disease
Lumbar Spine Degeneration
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective is to determine the validity of the Six-Minute-Walking Test (6WT) and Timed-Up and Go (TUG) test to measure objective functional impairment (OFI) in patients undergoing either in...
Detailed Description
The purposes of the project are to assess the ability of the Six-Minute-Walking Test (6WT) and Timed-Up and Go (TUG) test to measure and classify the disease burden, and to determine their relation to...
Eligibility Criteria
Inclusion
- Patient with symptomatic lumbar Degenerate Disc Disease (DDD), scheduled for either either interlaminar epidural steroid injection (ESI) or transforaminal epidural steroid injections (TFESI)
- Male and Female subjects ≥ 18 years
- Written informed consent
Exclusion
- Pregnancy
- Inability to walk (extreme pain or severe neurological deficits)
- Severe Chronic Obstructive Lung Disease (COPD) corresponding to ≥ Gold III
- Severe heart failure corresponding to ≥ New York Heart Association (NYHA) III
- Lung cancer and diffuse parenchymal lung disease
- Other medical reasons interfering with the patient's ability to walk and perform the 6WT/TUG (e.g., osteoarthritis disease of the lower extremities, Parkinson's disease, heart failure, hip or knee prosthesis etc.)
- Unavailability for follow up and/or inability to complete assessment (planning to move, no smartphone, etc.).
Key Trial Info
Start Date :
July 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 20 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04062942
Start Date
July 15 2019
End Date
December 20 2021
Last Update
July 26 2022
Active Locations (2)
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1
Kantonsspital St. Gallen / Department of Neurosurgery
Sankt Gallen, Switzerland, 9000
2
University Hospital Zürich / Department of Neurosurgery
Zurich, Switzerland, 8091