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| Name | Class |
|---|---|
| PD Dr. med. Martin Stienen, Klinik für Neurochirurgie, Universitätsspital Zürich | UNKNOWN |
| PD Dr. med. David Bellut, Klinik für Neurochirurgie, Universitätsspital Zürich | UNKNOWN |
| PD Dr. med. Oliver Gautschi, Neuro- und Wirbelsäulen Zentrum Zentralschweiz, Luzern |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2-6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Raw Walking distance - day 1 | Difference in Six-minute-walking test (6WD, in m) between baseline and 1-day follow-up | 1 day |
| Raw Walking distance - day 7 | Difference in 6WD (in m) between baseline and 7-day follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Nicolai Maldaner, MD | Kantonsspital St. Gallen / Department of Neurosurgery | Principal Investigator |
| Martin Stienen, MD | Universitätsspital Zürich / Department of Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital St. Gallen / Department of Neurosurgery | Sankt Gallen | 9000 | Switzerland | |||
| University Hospital Zürich / Department of Neurosurgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30831316 | Background | 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. | |
| 31042663 |
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| UNKNOWN |
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| 7 days |
| 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 | 1 day |
| TTFS and DTFS - day 7 | 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 | Difference in TTFS and DTFS, as measured by the 6WT, between the baseline and 4 weeks follow-up assessment | 4 weeks |
| 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 | 4 weeks |
| 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 | 4 weeks |
| 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 | 4 weeks |
| 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 | up to 4 weeks |
| Correlation 6WD/ODI | Correlation of 6WD with the ODI score at baseline and 4-week follow up | 4 weeks |
| Correlation 6WD/COMI | Correlation of 6WD with the COMI score at baseline and 4-week follow up | 4 weeks |
| Correlation 6WD/SF-12 | Correlation of 6WD with the SF-12 score at baseline and 4-week follow up | 4 weeks |
| Correlation 6WD/NRS Pain | 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 | Correlation of 6WD with the TUG test at baseline and 4-week follow up | 4 weeks |
| TUG T-Score | Difference in TUG T-score between the baseline (before injection) and 4-week follow-up assessment (after injection) | 4 weeks |
| Correlations TUG/PROMS | Correlation of TUG T-score with the ODI/COMI/NRS Pain/SF-12 score at baseline and follow up | 4 weeks |
| Zurich |
| 8091 |
| Switzerland |
| 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. |
| ID | Term |
|---|---|
| C535531 | Intervertebral disc disease |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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