Lumbosacral Spinal Stenosis - Non-Invasive Postural Therapy for Older Adult Veterans (LSS-NIPT)

Baltimore Va Medical Center, Baltimore MD

Investigators

Abstract

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.