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

July 22, 2026 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
        • Contact:
        • Principal Investigator:
          • Beth B. Hogans, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Coordinated suite of DME and training to support continuous maintenance of flexion posture during the 6 week trial.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in mobility by actigraph (positive, negative, or zero) as determined by the difference in mobility at Week 6 compared to baseline
Time Frame: Week 6
Actigraph mobility
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Beth B. Hogans, MD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E4412-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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