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RecruitingNCT06089746LSS-NIPTUpdated Jul 24, 2026

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

An interventional study of NIPT in Lumbar Spinal Stenosis, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
55 Years to 80 Years
Sex
All
01

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.

02

Conditions studied

  • Lumbar Spinal Stenosis

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03

In context

Spinal Stenosis

458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.

This study's planned enrollment of 20 is below the median of 80 across 281 interventional studies indexed under Spinal Stenosis.

Browse Spinal Stenosis studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.

Browse VA Office of Research and Development studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Feasibility

    Patients with LSS will receive DME and training to support continuous maintenance of flexion posture during the 6 week trial. All participants will be asked to wear actigraphs and pedometers intermittently and to complete questionnaires and mobility assessments.

    Other: NIPT

Interventions

  • OtherNIPT

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

06

What researchers measure

Primary outcomes

  1. Change in mobility by actigraph (positive, negative, or zero) as determined by the difference in mobility at Week 6 compared to baseline

    Actigraph mobility

    Time frame: Week 6

07

Study locations

1 of 1 sites recruiting
  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
    Baltimore, Maryland 21201, United States
    Recruiting
    • Beth B Hogans, MD · ContactBeth.Hogans@va.gov · (410) 605-7000
    • Beth B. Hogans, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Yes — A Limited Dataset will be created and shared pursuant to a Data Use Agreement appropriately limiting the use of the dataset and prohibiting the recipient from identifying or re-identifying or taking steps to identify or re-identify any individual whose data are included in the dataset.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2024 (actual). Primary completion is estimated for Jan 2027, 26 months after the start.

Of 105 non-industry interventional studies with no phase under Spinal Stenosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 26 months is below that.

Counting every sponsor, half of 123 studies reached it within 30 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2023
First posted
Oct 18, 2023
StartActual
Nov 15, 2024
Primary completionEst.
Jan 31, 2027
CompletionEst.
Mar 30, 2027
Last update
Jul 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06089746
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Oct 18, 2023
Start date
Nov 15, 2024
Primary completion
Jan 31, 2027 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Jul 24, 2026

Study contacts

Beth B Hogans, MD
Contact
Beth.Hogans@va.gov
(410) 605-7000
Beth B. Hogans, MD
principal investigator · Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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