Non-Invasive Postural Therapy for Lumbar Spinal Stenosis
(LSS-NIPT Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on non-invasive therapy, so you might not need to change your medication routine, but it's best to confirm with the trial coordinators.
What data supports the effectiveness of the treatment Non-Invasive Postural Therapy for Lumbar Spinal Stenosis?
Research shows that non-surgical treatments like physical therapy can help improve symptoms and function in patients with lumbar spinal stenosis. A case series demonstrated that patients experienced significant improvements in disability and symptoms with a noninvasive physical therapy program, and these gains were maintained for up to 18 months.12345
Is Non-Invasive Postural Therapy safe for humans?
Research on spinal manipulation therapy, which is similar to Non-Invasive Postural Therapy, shows that about half of the patients experience mild and temporary side effects, like muscle soreness. Serious side effects are rare, but it's important to discuss potential risks with your healthcare provider.678910
How is Non-Invasive Postural Therapy different from other treatments for lumbar spinal stenosis?
Research Team
Beth B. Hogans, MD
Principal Investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Eligibility Criteria
This trial is for older adult Veterans with lumbar spinal stenosis who experience back/leg pain when walking or standing. They must have had symptoms for over 3 months, tried non-surgical treatments, and be able to walk 50 feet unaided. Exclusions include previous back surgery for spinal stenosis, certain spine conditions like severe scoliosis, inflammatory diseases affecting the spine, and moderate to severe arthritis preventing walking.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DME and training to support continuous maintenance of flexion posture during the 6-week trial
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Non-Invasive Postural Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor