Clinical trial NCT04062942: 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)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Disc Disease
Lumbar Spine Degeneration
Lumbar Spinal Stenosis
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
Collaborators: name: Prof. Dr. Astrid Weyerbrock, Klinik für Neurochirurgie, Kantonsspital St. Gallen
name: PD Dr. med. Martin Stienen, Klinik für Neurochirurgie, Universitätsspital Zürich
name: PD Dr. med. David Bellut, Klinik für Neurochirurgie, Universitätsspital Zürich
name: med. pract. Markéta Sosnová, Klinik für Neurochirurgie, Kantonsspital St. Gallen
name: med. pract. Michal Ziga, Klinik für Neurochirurgie, Kantonsspital St. Gallen
name: med. pract.Valentin Steinsiepe, Klinik für Neurochirurgie, Kantonsspital St. Gallen
name: Dr. med. Anna Zeitlberger, Klinik für Neurochirurgie, Kantonsspital St. Gallen
name: PD Dr. med. Oliver Gautschi, Neuro- und Wirbelsäulen Zentrum Zentralschweiz, Luzern
First posted: 2019-08-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting to the neurosurgical department of the Kantonsspital St. Gallen (KSSG) or the Univesity Hospital Zürich (USZ) with DDD fulfilling the inclusion criteria and scheduled for ESI or TFESI will be considered for this study.

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 interlaminar epidural steroid injection (ESI) or transforaminal epidural steroid injections (TFESI) for lumbar degenerative disc disease (DDD)

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 already established subjective patient reported outcome measures (PROMs)in patients treated with either interlaminar epidural steroid injection (ESI) or transforaminal epidural steroid injections (TFESI) for lumbar degenerative disc disease (DDD). No research has so far determined its validity to determine OFI in a cohort of patients managed conservatively. We want to use an existing smartphone-applications for the 6WT and TUG test. Applying self-measurement of the 6WT within the context of a two center observational study will determine OFI in patients before and after (TF)ESI. The results of this study add to the understanding of achievable objective outcomes after steroid injection applied to patients with DDD.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.).

Primary outcomes:
measure: Raw Walking distance
timeFrame: 2-6 weeks
Secondary outcomes:
measure: Raw Walking distance - day 1
timeFrame: 1 day
measure: Raw Walking distance - day 7
timeFrame: 7 days
measure: TTFS and DTFS - day 1
timeFrame: 1 day
measure: TTFS and DTFS - day 7
timeFrame: 7 days
measure: TTFS and DTFS - 4 weeks
timeFrame: 4 weeks
measure: ODI
timeFrame: 4 weeks
measure: COMI
timeFrame: 4 weeks
measure: SF -12
timeFrame: 4 weeks
measure: NRS Pain
timeFrame: up to 4 weeks
measure: Correlation 6WD/ODI
timeFrame: 4 weeks
measure: Correlation 6WD/COMI
timeFrame: 4 weeks
measure: Correlation 6WD/SF-12
timeFrame: 4 weeks
measure: Correlation 6WD/NRS Pain
timeFrame: up to 4 weeks
measure: Correlation 6WD/TUG
timeFrame: 4 weeks
measure: TUG T-Score
timeFrame: 4 weeks
measure: Correlations TUG/PROMS
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St. Gallen / Department of Neurosurgery
city: Zürich
country: Switzerland
facility: University Hospital Zürich / Department of Neurosurgery
Study officials:
affiliation: Kantonsspital St. Gallen / Department of Neurosurgery
name: Nicolai Maldaner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsspital Zürich / Department of Neurosurgery
name: Martin Stienen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stienen MN, Ho AL, Staartjes VE, Maldaner N, Veeravagu A, Desai A, Gautschi OP, Bellut D, Regli L, Ratliff JK, Park J. Objective measures of functional impairment for degenerative diseases of the lumbar spine: a systematic review of the literature. Spine J. 2019 Jul;19(7):1276-1293. doi: 10.1016/j.spinee.2019.02.014. Epub 2019 Mar 2.
citation: Stienen MN, Maldaner N, Joswig H, Corniola MV, Bellut D, Prommel P, Regli L, Weyerbrock A, Schaller K, Gautschi OP. Objective functional assessment using the "Timed Up and Go" test in patients with lumbar spinal stenosis. Neurosurg Focus. 2019 May 1;46(5):E4. doi: 10.3171/2019.2.FOCUS18618.