Lumbosacral Spinal Stenosis - Non-Invasive Postural Therapy for Older Adult Veterans

Phase

N/A

Condition

Spinal Stenosis

Spondylolisthesis

Treatment

NIPT

Clinical Study ID

NCT06089746

E4412-P

Ages 60-80
All Genders

Study 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, 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.

Eligibility Criteria

Inclusion

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 orthighs
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 Stenosisat 1 or 2 levels
Prior treatment for Spinal Stenosis including therapy, medication, epiduralinjections, 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 legsymptoms 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), withavailability to increase ambulation on flat surfaces

Exclusion

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 5minutes, by sitting down
Rapid increase in symptoms with lumbar flexion such as sitting, Increase in symptomsbrought 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 freeambulation 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 mayinterfere with completion of six-week treatment trial
Planned surgery or procedure in the 6-week study period

Study Design