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

Lumbar Spinal Stenosis Clinical Trial

— LSS-NIPT  

Official title:

Lumbosacral Spinal Stenosis - Non-Invasive Postural Therapy for Older Adult Veterans (LSS-NIPT)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06089746
• Other study ID #: E4412-P
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: February 16, 2026

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: Beth B Hogans, MD
• Phone: (410) 605-7000
• Email: Beth.Hogans[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 16, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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 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 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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Other:
• NIPT
Coordinated suite of DME and training to support continuous maintenance of flexion posture during the 6 week trial.

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mobility by actigraph (positive, negative, or zero) as determined by the difference in mobility at Week 6 compared to baseline	Actigraph mobility	Week 6