Skip to main content
Clinical Trials/NCT06089746
NCT06089746
Recruiting
Not Applicable

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

VA Office of Research and Development1 site in 1 country20 target enrollmentNovember 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbar Spinal Stenosis
Sponsor
VA Office of Research and Development
Enrollment
20
Locations
1
Primary Endpoint
Change in mobility by actigraph (positive, negative, or zero) as determined by the difference in mobility at Week 6 compared to baseline
Status
Recruiting
Last Updated
4 months ago

Overview

Brief Summary

Lumbosacral spinal stenosis (LSS) is a leading cause of limited mobility, reduced independence, and poor health outcomes in older adults, and is very common in older adult Veterans. Several years ago, major research studies indicated that surgery for LSS was more effective than usual (medical) management. Nonetheless, there are many patients for whom surgery is not the ideal therapy. There have been reports that modifications in daily activities including temporary use of a modified rolling walker and changes in sleep positioning may help relieve LSS. The investigators have assembled a VA team to study this carefully. The investigators will recruit a small group of older adult Veterans with LSS to try out this program; the investigators will monitor them closely for relief of their symptoms and improvements in walking. The investigators will, as part of this small study, try to understand potential barriers to use of this therapy. The investigators will interview the Veterans and healthcare providers to identify problems that may arise in trying this therapy. If this small study works, the investigators plan to expand the effort.

Registry
clinicaltrials.gov
Start Date
November 15, 2024
End Date
November 30, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Veterans receiving care at participating VA
  • Ability to read and write English and understand instructions
  • Agrees to comply with instructions
  • Symptoms for over 3 months
  • Diagnosis of Lumbar Spinal Stenosis as the cause of symptoms
  • Discomfort involving low back pain and / or neurogenic claudication of legs or thighs
  • Back and/or leg symptoms greater than 3/10 provoked by walking and / or standing
  • X ray, CT, or MRI performed within the last 12 months shows Lumbar Spinal Stenosis at 1 or 2 levels
  • Prior treatment for Spinal Stenosis including therapy, medication, epidural injections, but not surgery
  • Relief of pain (standardly within 5 minutes) by sitting down

Exclusion Criteria

  • Previous Low Back Surgery for SS including decompression or fusion
  • Successful Spinal Stenosis Treatment (such as injection) over the prior 3 months
  • X ray, CT, or MRI shows Lumbar Spinal Stenosis in 3 or 4 levels
  • Prior Lumbar Fracture
  • Scoliosis with Cobb angle over 20 degrees on weight bearing AP Views
  • Inflammatory arthropathy involving the Lumbar Spine, such as RA
  • Radiculopathy attributed to herniated disc
  • Suspected or confirmed moderate to severe large fiber neuropathy
  • Failure of relief of back or leg pain brought on by standing or walking, within 5 minutes, by sitting down
  • Rapid increase in symptoms with lumbar flexion such as sitting, Increase in symptoms brought on by leaning on grocery cart or walker

Outcomes

Primary Outcomes

Change in mobility by actigraph (positive, negative, or zero) as determined by the difference in mobility at Week 6 compared to baseline

Time Frame: Week 6

Actigraph mobility

Study Sites (1)

Loading locations...

Similar Trials