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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 60 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06089746
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 VA Office of Research and Development
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Beth B. Hogans, MD
Principal Investigator Affiliation Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 U.S. Fed
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Lumbar Spinal Stenosis
Arms & Interventions

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.

Interventions

Other: - NIPT

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Baltimore, Maryland

Status

Address

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

Baltimore, Maryland, 21201

Site Contact

Beth B Hogans, MD

[email protected]

410-605-7000

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