- ICH GCP
- US Clinical Trials Registry
- 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)
July 22, 2022 updated by: Nicolai Maldaner, Cantonal Hospital of St. Gallen
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)
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saint Gallen, Switzerland, 9000
- Kantonsspital St. Gallen / Department of Neurosurgery
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Zürich, Switzerland, 8091
- University Hospital Zürich / Department of Neurosurgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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DDD patients
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Raw Walking distance
Time Frame: 2-6 weeks
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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).
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2-6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Raw Walking distance - day 1
Time Frame: 1 day
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Difference in Six-minute-walking test (6WD, in m) between baseline and 1-day follow-up
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1 day
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Raw Walking distance - day 7
Time Frame: 7 days
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Difference in 6WD (in m) between baseline and 7-day follow-up
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7 days
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TTFS and DTFS - day 1
Time Frame: 1 day
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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
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1 day
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TTFS and DTFS - day 7
Time Frame: 7 days
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Difference in TTFS and DTFS, as measured by the 6WT, between the baseline and 7-days follow-up assessment
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7 days
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TTFS and DTFS - 4 weeks
Time Frame: 4 weeks
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Difference in TTFS and DTFS, as measured by the 6WT, between the baseline and 4 weeks follow-up assessment
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4 weeks
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ODI
Time Frame: 4 weeks
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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
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4 weeks
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COMI
Time Frame: 4 weeks
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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
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4 weeks
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SF -12
Time Frame: 4 weeks
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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
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4 weeks
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NRS Pain
Time Frame: up to 4 weeks
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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
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up to 4 weeks
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Correlation 6WD/ODI
Time Frame: 4 weeks
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Correlation of 6WD with the ODI score at baseline and 4-week follow up
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4 weeks
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Correlation 6WD/COMI
Time Frame: 4 weeks
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Correlation of 6WD with the COMI score at baseline and 4-week follow up
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4 weeks
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Correlation 6WD/SF-12
Time Frame: 4 weeks
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Correlation of 6WD with the SF-12 score at baseline and 4-week follow up
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4 weeks
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Correlation 6WD/NRS Pain
Time Frame: up to 4 weeks
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Correlation of 6WD with the NRS pain score at baseline and 1-day, 7-days and 4-week follow up
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up to 4 weeks
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Correlation 6WD/TUG
Time Frame: 4 weeks
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Correlation of 6WD with the TUG test at baseline and 4-week follow up
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4 weeks
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TUG T-Score
Time Frame: 4 weeks
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Difference in TUG T-score between the baseline (before injection) and 4-week follow-up assessment (after injection)
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4 weeks
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Correlations TUG/PROMS
Time Frame: 4 weeks
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Correlation of TUG T-score with the ODI/COMI/NRS Pain/SF-12 score at baseline and follow up
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicolai Maldaner, MD, Kantonsspital St. Gallen / Department of Neurosurgery
- Principal Investigator: Martin Stienen, MD, Universitätsspital Zürich / Department of Neurosurgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2019
Primary Completion (Actual)
December 20, 2021
Study Completion (Actual)
December 20, 2021
Study Registration Dates
First Submitted
August 17, 2019
First Submitted That Met QC Criteria
August 19, 2019
First Posted (Actual)
August 20, 2019
Study Record Updates
Last Update Posted (Actual)
July 26, 2022
Last Update Submitted That Met QC Criteria
July 22, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OFI INJ - 1.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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