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AzTrials

Lumbar Disc DiseaseNCT04062942

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)

An observational study of Lumbar Disc Disease and Lumbar Spine Degeneration, run by Cantonal Hospital of St. Gallen at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
50 participants
Where
2 sitesSwitzerland
Study dates
15 Jul 2019to 20 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.).

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

  • Kantonsspital St. Gallen / Department of Neurosurgery

    Sankt Gallen, 9000

  • University Hospital Zürich / Department of Neurosurgery

    Zurich, 8091

Other trials in Switzerland

About this study

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)

Read the 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.

Medical subject headings
Intervertebral disc disease, Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04062942
Study groupRoleWhat they receive
DDD patientsAll 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 2-6 weeks

Secondary outcomes (16)

  1. Raw Walking distance - day 1

    Difference in Six-minute-walking test (6WD, in m) between baseline and 1-day follow-up

    Measured: 1 day

  2. Raw Walking distance - day 7

    Difference in 6WD (in m) between baseline and 7-day follow-up

    Measured: 7 days

  3. 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

    Measured: 1 day

  4. TTFS and DTFS - day 7

    Difference in TTFS and DTFS, as measured by the 6WT, between the baseline and 7-days follow-up assessment

    Measured: 7 days

  5. TTFS and DTFS - 4 weeks

    Difference in TTFS and DTFS, as measured by the 6WT, between the baseline and 4 weeks follow-up assessment

    Measured: 4 weeks

  6. 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

    Measured: 4 weeks

  7. 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

    Measured: 4 weeks

  8. 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

    Measured: 4 weeks

  9. 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

    Measured: up to 4 weeks

  10. Correlation 6WD/ODI

    Correlation of 6WD with the ODI score at baseline and 4-week follow up

    Measured: 4 weeks

  11. Correlation 6WD/COMI

    Correlation of 6WD with the COMI score at baseline and 4-week follow up

    Measured: 4 weeks

  12. Correlation 6WD/SF-12

    Correlation of 6WD with the SF-12 score at baseline and 4-week follow up

    Measured: 4 weeks

  13. Correlation 6WD/NRS Pain

    Correlation of 6WD with the NRS pain score at baseline and 1-day, 7-days and 4-week follow up

    Measured: up to 4 weeks

  14. Correlation 6WD/TUG

    Correlation of 6WD with the TUG test at baseline and 4-week follow up

    Measured: 4 weeks

  15. TUG T-Score

    Difference in TUG T-score between the baseline (before injection) and 4-week follow-up assessment (after injection)

    Measured: 4 weeks

  16. Correlations TUG/PROMS

    Correlation of TUG T-score with the ODI/COMI/NRS Pain/SF-12 score at baseline and follow up

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2019
  2. Study start15 Jul 2019
  3. Primary completion20 Dec 2021
  4. Study completion20 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04062942
Sponsor's protocol ID
OFI INJ - 1.0
Status last verified
Jul 2022
First submitted
17 Aug 2019
Last updated
26 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 30831316

  • 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.

    PubMed 31042663

Questions about this trial

What is this clinical trial studying?

An observational study of Lumbar Disc Disease and Lumbar Spine Degeneration, run by Cantonal Hospital of St. Gallen at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Raw Walking distance (time frame: 2-6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04062942, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.

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