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)

NCT ID: NCT04062942

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2021-12-20

Brief 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 degenerative disc disease (DDD)

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.

Conditions

Lumbar Disc Disease; Lumbar Spine Degeneration; Lumbar Spinal Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Dr. Astrid Weyerbrock, Klinik für Neurochirurgie, Kantonsspital St. Gallen

UNKNOWN

Sponsor Role: collaborator

PD Dr. med. Martin Stienen, Klinik für Neurochirurgie, Universitätsspital Zürich

UNKNOWN

Sponsor Role: collaborator

PD Dr. med. David Bellut, Klinik für Neurochirurgie, Universitätsspital Zürich

UNKNOWN

Sponsor Role: collaborator

med. pract. Markéta Sosnová, Klinik für Neurochirurgie, Kantonsspital St. Gallen

UNKNOWN

Sponsor Role: collaborator

med. pract. Michal Ziga, Klinik für Neurochirurgie, Kantonsspital St. Gallen

UNKNOWN

Sponsor Role: collaborator

med. pract.Valentin Steinsiepe, Klinik für Neurochirurgie, Kantonsspital St. Gallen

UNKNOWN

Sponsor Role: collaborator

Dr. med. Anna Zeitlberger, Klinik für Neurochirurgie, Kantonsspital St. Gallen

UNKNOWN

Sponsor Role: collaborator

PD Dr. med. Oliver Gautschi, Neuro- und Wirbelsäulen Zentrum Zentralschweiz, Luzern

UNKNOWN

Sponsor Role: collaborator

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: lead

Responsible Party

Nicolai Maldaner

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicolai Maldaner, MD

Role: PRINCIPAL_INVESTIGATOR

Kantonsspital St. Gallen / Department of Neurosurgery

Martin Stienen, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsspital Zürich / Department of Neurosurgery

Locations

Kantonsspital St. Gallen / Department of Neurosurgery

Sankt Gallen, , Switzerland

University Hospital Zürich / Department of Neurosurgery

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 30831316 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31042663 (View on PubMed)

Other Identifiers

OFI INJ - 1.0

Identifier Type: -

Identifier Source: org_study_id