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

Primary Purpose

Lumbar Spinal Stenosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NIPT
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lumbar Spinal Stenosis

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Feasibility

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 21, 2023
Last Updated
October 12, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT06089746
Brief Title
Lumbosacral Spinal Stenosis - Non-Invasive Postural Therapy for Older Adult Veterans
Acronym
LSS-NIPT
Official Title
Lumbosacral Spinal Stenosis - Non-Invasive Postural Therapy for Older Adult Veterans (LSS-NIPT)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 15, 2024 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
February 16, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Feasibility
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
NIPT
Intervention Description
Coordinated suite of DME and training to support continuous maintenance of flexion posture during the 6 week trial.
Primary Outcome Measure Information:
Title
Change in mobility by actigraph (positive, negative, or zero) as determined by the difference in mobility at Week 6 compared to baseline
Description
Actigraph mobility
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beth B Hogans, MD
Phone
(410) 605-7000
Email
Beth.Hogans@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth B. Hogans, MD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth B Hogans, MD
Phone
410-605-7000
Email
Beth.Hogans@va.gov
First Name & Middle Initial & Last Name & Degree
Beth B. Hogans, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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