Status:
RECRUITING
Lumbosacral Spinal Stenosis - Non-Invasive Postural Therapy for Older Adult Veterans
Lead Sponsor:
VA Office of Research and Development
Conditions:
Lumbar Spinal Stenosis
Eligibility:
All Genders
60-80 years
Phase:
NA
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06089746
Start Date
November 15 2024
End Date
November 30 2026
Last Update
December 16 2025
Active Locations (1)
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1
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201