Skip to main content
OpenTrials
Completed

NCT Number: 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)

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lumbar Disc Disease Bone Diseases Intervertebral disc disease Lumbar Spinal Stenosis Lumbar Spine Degeneration Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kantonsspital St. Gallen / Department of Neurosurgery, Sankt Gallen, Switzerland

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. Raw Walking distance - day 7

    Time frame: 7 days

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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Correlation 6WD/ODI

    Time frame: 4 weeks

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

  11. Correlation 6WD/COMI

    Time frame: 4 weeks

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

  12. Correlation 6WD/SF-12

    Time frame: 4 weeks

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

  13. 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

  14. Correlation 6WD/TUG

    Time frame: 4 weeks

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

  15. 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)

  16. 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

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Collaborators

  • PD Dr. med. David Bellut, Klinik für Neurochirurgie, Universitätsspital Zürich
  • PD Dr. med. Martin Stienen, Klinik für Neurochirurgie, Universitätsspital Zürich
  • PD Dr. med. Oliver Gautschi, Neuro- und Wirbelsäulen Zentrum Zentralschweiz, Luzern

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2019
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.