Lumbar Disc Disease, Lumbar Spinal Stenosis, Lumbar Spine Degeneration
Conditions
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.
Interventions
None listed
Sponsors
PD Dr. med. Martin Stienen, Klinik für Neurochirurgie, Universitätsspital Zürich
PD Dr. med. David Bellut, Klinik für Neurochirurgie, Universitätsspital Zürich
PD Dr. med. Oliver Gautschi, Neuro- und Wirbelsäulen Zentrum Zentralschweiz, Luzern
Cantonal Hospital of St. Gallen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Raw Walking distance | 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
| Measure | Time frame | Description |
|---|---|---|
| Raw Walking distance - day 7 | 7 days | Difference in 6WD (in m) between baseline and 7-day follow-up |
| TTFS and DTFS - day 1 | 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 |
| TTFS and DTFS - day 7 | 7 days | Difference in TTFS and DTFS, as measured by the 6WT, between the baseline and 7-days follow-up assessment |
| TTFS and DTFS - 4 weeks | 4 weeks | Difference in TTFS and DTFS, as measured by the 6WT, between the baseline and 4 weeks follow-up assessment |
| ODI | 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 |
| COMI | 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 |
| SF -12 | 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 |
| Raw Walking distance - day 1 | 1 day | Difference in Six-minute-walking test (6WD, in m) between baseline and 1-day follow-up |
| Correlation 6WD/ODI | 4 weeks | Correlation of 6WD with the ODI score at baseline and 4-week follow up |
| Correlation 6WD/COMI | 4 weeks | Correlation of 6WD with the COMI score at baseline and 4-week follow up |
| Correlation 6WD/SF-12 | 4 weeks | Correlation of 6WD with the SF-12 score at baseline and 4-week follow up |
| Correlation 6WD/NRS Pain | up to 4 weeks | Correlation of 6WD with the NRS pain score at baseline and 1-day, 7-days and 4-week follow up |
| Correlation 6WD/TUG | 4 weeks | Correlation of 6WD with the TUG test at baseline and 4-week follow up |
| TUG T-Score | 4 weeks | Difference in TUG T-score between the baseline (before injection) and 4-week follow-up assessment (after injection) |
| Correlations TUG/PROMS | 4 weeks | Correlation of TUG T-score with the ODI/COMI/NRS Pain/SF-12 score at baseline and follow up |
| NRS Pain | 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 |
Countries
Switzerland
Outcome results
None listed