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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Raw Walking distance
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.).
结局指标
主要结局
Raw Walking distance
时间窗: 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).
次要结局
- SF -12(4 weeks)
- Correlation 6WD/ODI(4 weeks)
- TTFS and DTFS - 4 weeks(4 weeks)
- Raw Walking distance - day 1(1 day)
- TTFS and DTFS - day 1(1 day)
- TTFS and DTFS - day 7(7 days)
- Raw Walking distance - day 7(7 days)
- ODI(4 weeks)
- NRS Pain(up to 4 weeks)
- TUG T-Score(4 weeks)
- COMI(4 weeks)
- Correlation 6WD/COMI(4 weeks)
- Correlation 6WD/NRS Pain(up to 4 weeks)
- Correlations TUG/PROMS(4 weeks)
- Correlation 6WD/SF-12(4 weeks)
- Correlation 6WD/TUG(4 weeks)
研究者
Nicolai Maldaner
Principal Investigator
Cantonal Hospital of St. Gallen