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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

• Ability to walk 50 feet without a cane or walker

• General health presents ability to increase activity level if Back and / or leg symptoms resolve

• If home has stairs and patient uses multiple levels, must have steady handrail

• Transportation routinely available by car or car service and not by bus

• Home location allows restriction of walking to flat surfaces (lack of hills), with availability to increase ambulation on flat surfaces

Locations
United States
Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
RECRUITING
Baltimore
Contact Information
Primary
Beth B Hogans, MD
Beth.Hogans@va.gov
(410) 605-7000
Time Frame
Start Date: 2024-11-15
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 20
Treatments
Experimental: Feasibility
Patients with LSS will receive DME and training to support continuous maintenance of flexion posture during the 6 week trial. All participants will be asked to wear actigraphs and pedometers intermittently and to complete questionnaires and mobility assessments.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov