Non-invasive therapy for older veterans with spinal stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on older adult veterans suffering from lumbar spinal stenosis, a condition that limits mobility and independence. It aims to evaluate the effectiveness of non-invasive postural therapy, including the use of modified rolling walkers and changes in sleep positioning, to alleviate symptoms and improve walking ability. A small group of veterans will be recruited to participate in this program, and their progress will be closely monitored to assess symptom relief and identify any barriers to therapy use. The study seeks to provide insights into alternative management strategies for those who are not ideal candidates for surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Beth B. Hogans, MD — Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
• Study coordinator: Beth B Hogans, MD
• Email: Beth.Hogans@va.gov
• Phone: (410) 605-7000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.