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

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

      • Saint Gallen, Switzerland, 9000
        • Kantonsspital St. Gallen / Department of Neurosurgery
      • Zürich, Switzerland, 8091
        • University Hospital Zürich / Department of Neurosurgery

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Raw Walking distance
Time Frame: 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).
2-6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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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