NCT06089746 Lumbosacral Spinal Stenosis - Non-Invasive Postural Therapy for Older Adult Veterans
| NCT ID | NCT06089746 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Lumbar Spinal Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-11-15 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 * Ability to walk 30 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 * Current symptoms are problematic within 7 minutes or one block of walking 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
Contact & Investigator
Beth B. Hogans, MD
PRINCIPAL INVESTIGATOR
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Frequently Asked Questions
Who can join the NCT06089746 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 80 Years, studying Lumbar Spinal Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06089746 currently recruiting?
Yes, NCT06089746 is actively recruiting participants. Contact the research team at Beth.Hogans@va.gov for enrollment information.
Where is the NCT06089746 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06089746 clinical trial?
NCT06089746 is sponsored by VA Office of Research and Development. The principal investigator is Beth B. Hogans, MD at Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD. The trial plans to enroll 20 participants.