Lumbar Spinal StenosisLSS-NIPTNCT06089746
Lumbosacral Spinal Stenosis - Non-Invasive Postural Therapy for Older Adult Veterans
A study testing NIPT in people with Lumbar Spinal Stenosis, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- NIPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2024to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Beth B Hogans, MD, (410) 605-7000, Beth.Hogans@va.gov
Beth B. Hogans, MD
About this study
Official title: 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.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- NIPT
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIPTOther
Coordinated suite of DME and training to support continuous maintenance of flexion posture during the 6 week trial.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility | Experimental | 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. Receives: Other: NIPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mobility by actigraph (positive, negative, or zero) as determined by the difference in mobility at Week 6 compared to baseline
Actigraph mobility
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start15 Nov 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Beth B. Hogans, MD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089746
- Sponsor's protocol ID
- E4412-P
- Acronym
- LSS-NIPT
- Status last verified
- Jul 2026
- First submitted
- 21 Aug 2023
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbosacral Spinal Stenosis - Non-Invasive Postural Therapy for Older Adult Veterans (LSS-NIPT)
- ClinicalTrials.gov ID
- NCT06089746
- Acronym / sponsor ID
- LSS-NIPT / E4412-P
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility | Experimental | Other: NIPTPatients 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIPTCoordinated suite of DME and training to support continuous maintenance of flexion posture during the 6 week trial. | Other | Feasibility |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: 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.
Related trials for Lumbar Spinal Stenosis
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Thoracic-Lumbar Arthrodesis- Implanet Jazz
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beth B. Hogans, MD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIPT in people with Lumbar Spinal Stenosis, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beth B Hogans, MD ((410) 605-7000, Beth.Hogans@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.