NCT06089746 · VA Office of Research and Development
Lumbosacral Spinal Stenosis - Non-Invasive Postural Therapy for Older Adult Veterans
(LSS-NIPT)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
NIPT
Coordinated suite of DME and training to support continuous maintenance of flexion posture during the 6 week trial.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 16, 2025 · Source of record for eligibility and locations