RECRUITING

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

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Conditions

Lumbar Spinal Stenosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-15
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06089746

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.

Ages Eligible for Study:60 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veterans receiving care at participating VA
  2. * Ability to read and write English and understand instructions
  3. * Agrees to comply with instructions
  4. * Symptoms for over 3 months
  5. * Diagnosis of Lumbar Spinal Stenosis as the cause of symptoms
  6. * Discomfort involving low back pain and / or neurogenic claudication of legs or thighs
  7. * Back and/or leg symptoms greater than 3/10 provoked by walking and / or standing
  8. * X ray, CT, or MRI performed within the last 12 months shows Lumbar Spinal Stenosis at 1 or 2 levels
  9. * Prior treatment for Spinal Stenosis including therapy, medication, epidural injections, but not surgery
  10. * Relief of pain (standardly within 5 minutes) by sitting down
  11. * Ability to walk 50 feet without a cane or walker
  12. * General health presents ability to increase activity level if Back and / or leg symptoms resolve
  13. * If home has stairs and patient uses multiple levels, must have steady handrail
  14. * Transportation routinely available by car or car service and not by bus
  15. * Home location allows restriction of walking to flat surfaces (lack of hills), with availability to increase ambulation on flat surfaces
  1. * Previous Low Back Surgery for SS including decompression or fusion
  2. * Successful Spinal Stenosis Treatment (such as injection) over the prior 3 months
  3. * X ray, CT, or MRI shows Lumbar Spinal Stenosis in 3 or 4 levels
  4. * Prior Lumbar Fracture
  5. * Scoliosis with Cobb angle over 20 degrees on weight bearing AP Views
  6. * Inflammatory arthropathy involving the Lumbar Spine, such as RA
  7. * Radiculopathy attributed to herniated disc
  8. * Suspected or confirmed moderate to severe large fiber neuropathy
  9. * Failure of relief of back or leg pain brought on by standing or walking, within 5 minutes, by sitting down
  10. * Rapid increase in symptoms with lumbar flexion such as sitting, Increase in symptoms brought on by leaning on grocery cart or walker
  11. * Reduced symptoms by lumbo-sacral extension
  12. * Vascular Claudication with ABI less than 60 or over 140
  13. * Prior bypass or stent surgery for PAD
  14. * Current foot, ankle, leg, or thigh infection or open ulcer
  15. * Current use of a Brace for foot, ankle, or knee pathology,
  16. * Moderate to severe arthritis of the Hip, knee, ankle or foot preventing pain free ambulation greater than 1 block
  17. * Neurologic or neurodegenerative induced gait pathology such as CVA, Parkinson's, NPH, Cervical Myelopathy
  18. * Current Medico Legal issues, active substance use, SI, HI, or other factors that may interfere with completion of six-week treatment trial
  19. * Planned surgery or procedure in the 6-week study period

Contacts and Locations

Study Contact

Beth B Hogans, MD
CONTACT
(410) 605-7000
Beth.Hogans@va.gov

Principal Investigator

Beth B. Hogans, MD
PRINCIPAL_INVESTIGATOR
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study Locations (Sites)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Beth B. Hogans, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-11-15
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2024-11-15
Study Completion Date2026-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Lumbar Spinal Stenosis