New Walker-and-Sleep therapy could help veterans with back pain avoid surgery
NCT ID NCT06089746
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This study tests a simple, non-surgical program for older veterans with lumbar spinal stenosis, a common cause of back and leg pain when walking or standing. The program includes using a modified rolling walker and changing sleep positions to relieve symptoms. Researchers will track improvements in mobility and interview participants to find any barriers to using this therapy. If successful, the approach could be expanded to help more people.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
RECRUITINGBaltimore, Maryland, 21201, United States
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Other studies related to the condition(s) this trial covers.
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