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)

Lumbar Spinal Stenosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062942
• Other study ID #: OFI INJ - 1.0
• Status: Completed
• Start date: July 15, 2019
• Est. completion date: December 20, 2021

Study information

• Verified date: July 2022
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Disc Disease
• Lumbar Spinal Stenosis
• Lumbar Spine Degeneration
• Spinal Diseases
• Spinal Stenosis

Locations

Country	Name	City	State
Switzerland	Kantonsspital St. Gallen / Department of Neurosurgery	Saint Gallen
Switzerland	University Hospital Zürich / Department of Neurosurgery	Zürich

Sponsors (9)

Lead Sponsor

Collaborator

Cantonal Hospital of St. Gallen

Dr. med. Anna Zeitlberger, Klinik für Neurochirurgie, Kantonsspital St. Gallen, med. pract. Markéta Sosnová, Klinik für Neurochirurgie, Kantonsspital St. Gallen, med. pract. Michal Ziga, Klinik für Neurochirurgie, Kantonsspital St. Gallen, med. pract.Valentin Steinsiepe, Klinik für Neurochirurgie, Kantonsspital St. Gallen, PD Dr. med. David Bellut, Klinik für Neurochirurgie, Universitätsspital Zürich, PD Dr. med. Martin Stienen, Klinik für Neurochirurgie, Universitätsspital Zürich, PD Dr. med. Oliver Gautschi, Neuro- und Wirbelsäulen Zentrum Zentralschweiz, Luzern, Prof. Dr. Astrid Weyerbrock, Klinik für Neurochirurgie, Kantonsspital St. Gallen

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View Citation

Stienen MN, Maldaner N, Joswig H, Corniola MV, Bellut D, Prömmel 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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Raw Walking distance	The difference in 6WD (in m), as measured with the 6WT, between the baseline (before injection) and 4-week (range 2-6 weeks) follow-up assessment (after injection).	2-6 weeks
Secondary	Raw Walking distance - day 1	Difference in Six-minute-walking test (6WD, in m) between baseline and 1-day follow-up	1 day
Secondary	Raw Walking distance - day 7	Difference in 6WD (in m) between baseline and 7-day follow-up	7 days
Secondary	TTFS and DTFS - day 1	Difference in Time to first symptoms (TTFS, in sec) and Distance to First Symptoms (DTFS, in m), as measured by the 6WT, between the baseline and 1-day follow-up assessment	1 day
Secondary	TTFS and DTFS - day 7	Difference in TTFS and DTFS, as measured by the 6WT, between the baseline and 7-days follow-up assessment	7 days
Secondary	TTFS and DTFS - 4 weeks	Difference in TTFS and DTFS, as measured by the 6WT, between the baseline and 4 weeks follow-up assessment	4 weeks
Secondary	ODI	Difference in PROM, as measured by the Oswestry Disability Index (ODI score, range 0% (best) - 100% (worst)), between the baseline- and 4-week follow-up assessment	4 weeks
Secondary	COMI	Difference in PROM, as measured by the Core Outcome Measure Index (COMI score, range 0 (best) - 10 (worst)), between the baseline- and 4-week follow-up assessment	4 weeks
Secondary	SF -12	Difference in in health-related quality of life (hrQoL), as measured by the SF-12 score (SF-12 score, range 0 (worst) - 1 (best)), between the baseline- and 4-week follow-up assessment	4 weeks
Secondary	NRS Pain	Difference in pain intensity, as measured by the NRS pain scale (NRS pain score, range 0 (best) - 10 (worst)), between the baseline- and 1-day, 7-day and 4-week follow-up assess-ments	up to 4 weeks
Secondary	Correlation 6WD/ODI	Correlation of 6WD with the ODI score at baseline and 4-week follow up	4 weeks
Secondary	Correlation 6WD/COMI	Correlation of 6WD with the COMI score at baseline and 4-week follow up	4 weeks
Secondary	Correlation 6WD/SF-12	Correlation of 6WD with the SF-12 score at baseline and 4-week follow up	4 weeks
Secondary	Correlation 6WD/NRS Pain	Correlation of 6WD with the NRS pain score at baseline and 1-day, 7-days and 4-week follow up	up to 4 weeks
Secondary	Correlation 6WD/TUG	Correlation of 6WD with the TUG test at baseline and 4-week follow up	4 weeks
Secondary	TUG T-Score	Difference in TUG T-score between the baseline (before injection) and 4-week follow-up assessment (after injection)	4 weeks
Secondary	Correlations TUG/PROMS	Correlation of TUG T-score with the ODI/COMI/NRS Pain/SF-12 score at baseline and follow up	4 weeks