Lumbosacral spinal stenosis (LSS) is a leading cause of limited mobility, reduced independence, and poor
health outcomes in older adults; and is especially prevalent in older adult Veterans. Several years ago, major
randomized clinical trials indicated that surgical intervention for LSS was more effective than usual (medical)
management. Nonetheless, there are many patients for whom surgery is not the ideal therapy. In some cases,
patients are not `good surgical candidates' due the presence multiple medical conditions such as [uncontrolled
type 2 diabetes mellitus (DM2)]. Other patients are considered less ideal for surgery because pain is a
prominent feature of their low back syndrome while simultaneously walking limitations, e.g., neurogenic
claudication, is less prominent. There is evidence that these patients are less likely to have good surgical
outcomes, and yet little is known about what other therapies might be effective. It is precisely the sickest and
most vulnerable patients with LSS who are in greatest need of alternative therapies. We propose a therapeutic
trial utilizing a low-cost, well-established non-invasive clinical device, repurposed for the relief of LSS-
associated pain. Current RR&D emphasis includes non-pharmacological treatments to improve
rehabilitation outcomes including pain and mobility. This proposal is based on the latest in peripheral
nerve research but takes a non-invasive approach to address a problem impacting a substantive percentage of
the millions of older adults with low back pain and dysmobility. Our specific aims include:
1. Gather and evaluate preliminary evidence that non-invasive postural therapy (NIPT) improves
rehabilitation outcomes including pain ratings and mobility over a 6-week pilot study of older adult
Veterans with LSS. In this study, 20 [older adult Veterans will receive instruction and equipment to support
holo-diurnal (all day-and-night) activity modification, e.g., modified walker use, adapted meal preparation /
leisure activities, and sleep positioning, to enhance sagittal flexion continuously and comfortably. Following 1
week baseline activity and sleep assessment, an initial 3-week treatment period (NIPT) will include activity
monitoring and daily pain assessment. During a second 3-week period, patients will use NIPT ad libitum,
activity and sleep monitoring will be repeated during week 6. The primary outcome measure is participant
mobility measured by actigraphy and pedometer. Secondary outcomes are patient-reported pain intensity and
interference, mobility, quality of life (PROMIS, EQ5D), and system usability; walker usage as measured by
tracking devices; as well as objective assessments of sleep duration and quality as measured by activity
monitoring.]
2. [Assess feasibility of, barriers to, and facilitators of non-invasive postural therapy (NIPT) holo-
diurnal implementation for older adult Veterans. The primary outcome in this arm of the study will be to
identify, through mixed methods approaches - the feasibility, barriers, and facilitators to implementing this
treatment intervention. We will recruit Veterans and health care providers (HCPs), e.g., primary care providers,
and physical therapists, for key informant interviews as well as questionnaires assessing feasibility of NIPT and
the extent to which HCPs view this as an option for older adult Veterans with dysmobility, pain, and
multimorbidity.]
The evidence gathered in this trial will support the development of future studies of non-pharmacological
therapies for older adult Veterans with low back pain and low back conditions.
Public Health Relevance Statement
[This study will advance understanding of lumbosacral spinal stenosis (LSS) a major cause of pain and
dysmobility in older adult Veterans and a leading cause of disability and loss of independence. Major research
studies have shown that surgery for LSS is more effective than usual (medical) management. Still, there are
many patients for whom surgery is not possible. There have been reports that temporary use of a modified
rolling walker or sleep positioning may help relieve LSS. Going further, our VA team has created a detailed
round-the-clock LSS management plan that addresses all daily activities. We will recruit a small group of older
adult Veterans with LSS to pilot this comprehensive modified activity program. Our team will support the day-
and-night lifestyle modifications and monitor participants closely for relief of symptoms and improvements in
walking. We will also assess potential barriers to adopting this therapy by interviewing Veterans and healthcare
providers regarding problems with therapy initiation.] If this small study works, we plan to expand the effort.
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