Non-invasive therapy for older veterans with spinal stenosis
Lumbosacral Spinal Stenosis - Non-Invasive Postural Therapy for Older Adult Veterans (LSS-NIPT)
NA · VA Office of Research and Development · NCT06089746
This study is testing a non-invasive therapy for older veterans with spinal stenosis to see if it can help them walk better and feel less pain without needing surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Drugs / interventions | cart |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06089746 on ClinicalTrials.gov |
What this trial studies
This study focuses on older adult veterans suffering from lumbar spinal stenosis, a condition that limits mobility and independence. It aims to evaluate the effectiveness of non-invasive postural therapy, including the use of modified rolling walkers and changes in sleep positioning, to alleviate symptoms and improve walking ability. A small group of veterans will be recruited to participate in this program, and their progress will be closely monitored to assess symptom relief and identify any barriers to therapy use. The study seeks to provide insights into alternative management strategies for those who are not ideal candidates for surgery.
Who should consider this trial
Good fit: Ideal candidates are older adult veterans diagnosed with lumbar spinal stenosis who have experienced symptoms for over three months and have not undergone surgery.
Not a fit: Patients who have already had surgery for spinal stenosis or those whose symptoms are not primarily due to lumbar spinal stenosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a non-surgical option for symptom relief and improved mobility in older veterans with lumbar spinal stenosis.
How similar studies have performed: While there have been studies on surgical interventions for spinal stenosis, this non-invasive approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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 * 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 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 * Reduced symptoms by lumbo-sacral extension * Vascular Claudication with ABI less than 60 or over 140 * Prior bypass or stent surgery for PAD * Current foot, ankle, leg, or thigh infection or open ulcer * Current use of a Brace for foot, ankle, or knee pathology, * Moderate to severe arthritis of the Hip, knee, ankle or foot preventing pain free ambulation greater than 1 block * Neurologic or neurodegenerative induced gait pathology such as CVA, Parkinson's, NPH, Cervical Myelopathy * Current Medico Legal issues, active substance use, SI, HI, or other factors that may interfere with completion of six-week treatment trial * Planned surgery or procedure in the 6-week study period
Where this trial is running
Baltimore, Maryland
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Beth B. Hogans, MD — Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
- Study coordinator: Beth B Hogans, MD
- Email: Beth.Hogans@va.gov
- Phone: (410) 605-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lumbar Spinal Stenosis