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New treatment option for Lumbar Spinal Stenosis
Official title Lumbosacral Spinal Stenosis - Non-Invasive Postural Therapy for Older Adult Veterans
ClinicalTrials.gov ID: NCT06089746
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 80
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.