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)

Completed

• Conditions: Lumbar Spine Degeneration; Lumbar Spinal Stenosis; Lumbar Disc Disease

• Registration Number: NCT04062942
• Lead Sponsor: Cantonal Hospital of St. Gallen

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.

Study Timeline

• Study Start: 2019-07-15
• Study First Submitted: 2019-08-17
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-20
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Raw Walking distance	2-6 weeks	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).

Secondary Outcome Measures

Name	Time	Method
SF -12	4 weeks	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
Correlation 6WD/ODI	4 weeks	Correlation of 6WD with the ODI score at baseline and 4-week follow up
TTFS and DTFS - 4 weeks	4 weeks	Difference in TTFS and DTFS, as measured by the 6WT, between the baseline and 4 weeks follow-up assessment
Raw Walking distance - day 1	1 day	Difference in Six-minute-walking test (6WD, in m) between baseline and 1-day follow-up
TTFS and DTFS - day 1	1 day	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
TTFS and DTFS - day 7	7 days	Difference in TTFS and DTFS, as measured by the 6WT, between the baseline and 7-days follow-up assessment
Raw Walking distance - day 7	7 days	Difference in 6WD (in m) between baseline and 7-day follow-up
ODI	4 weeks	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
NRS Pain	up to 4 weeks	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
TUG T-Score	4 weeks	Difference in TUG T-score between the baseline (before injection) and 4-week follow-up assessment (after injection)
COMI	4 weeks	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
Correlation 6WD/COMI	4 weeks	Correlation of 6WD with the COMI score at baseline and 4-week follow up
Correlation 6WD/NRS Pain	up to 4 weeks	Correlation of 6WD with the NRS pain score at baseline and 1-day, 7-days and 4-week follow up
Correlations TUG/PROMS	4 weeks	Correlation of TUG T-score with the ODI/COMI/NRS Pain/SF-12 score at baseline and follow up
Correlation 6WD/SF-12	4 weeks	Correlation of 6WD with the SF-12 score at baseline and 4-week follow up
Correlation 6WD/TUG	4 weeks	Correlation of 6WD with the TUG test at baseline and 4-week follow up

Trial Locations

Locations (2)

Kantonsspital St. Gallen / Department of Neurosurgery; 🇨🇭 Saint Gallen, Switzerland

University Hospital Zürich / Department of Neurosurgery; 🇨🇭 Zürich, Switzerland