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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
VA Office of Research and Development
Study ID
NCT06089746
Status
Recruiting
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Conditions

  • Lumbar Spinal Stenosis

Eligibility Criteria

Sex
ALL
Age
60 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 15, 2024
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDBaltimoreMaryland21201
Beth B Hogans, MD
[email protected]
410-605-7000
Beth B. Hogans, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD· Baltimore, MD

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