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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Switzerland
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cantonal Hospital of St. Gallen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Prof. Dr. Astrid Weyerbrock, Klinik für Neurochirurgie, Kantonsspital St. Gallen
PD Dr. med. Martin Stienen, Klinik für Neurochirurgie, Universitätsspital Zürich
med. pract. Markéta Sosnová, Klinik für Neurochirurgie, Kantonsspital St. Gallen
PD Dr. med. David Bellut, Klinik für Neurochirurgie, Universitätsspital Zürich
med. pract. Michal Ziga, Klinik für Neurochirurgie, Kantonsspital St. Gallen
med. pract.Valentin Steinsiepe, Klinik für Neurochirurgie, Kantonsspital St. Gallen
Dr. med. Anna Zeitlberger, Klinik für Neurochirurgie, Kantonsspital St. Gallen
PD Dr. med. Oliver Gautschi, Neuro- und Wirbelsäulen Zentrum Zentralschweiz, Luzern

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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