20 Participants Needed

Non-Invasive Postural Therapy for Lumbar Spinal Stenosis

(LSS-NIPT Trial)

BB
Overseen ByBeth B Hogans, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on non-invasive therapy, so you might not need to change your medication routine, but it's best to confirm with the trial coordinators.

What data supports the effectiveness of the treatment Non-Invasive Postural Therapy for Lumbar Spinal Stenosis?

Research shows that non-surgical treatments like physical therapy can help improve symptoms and function in patients with lumbar spinal stenosis. A case series demonstrated that patients experienced significant improvements in disability and symptoms with a noninvasive physical therapy program, and these gains were maintained for up to 18 months.12345

Is Non-Invasive Postural Therapy safe for humans?

Research on spinal manipulation therapy, which is similar to Non-Invasive Postural Therapy, shows that about half of the patients experience mild and temporary side effects, like muscle soreness. Serious side effects are rare, but it's important to discuss potential risks with your healthcare provider.678910

How is Non-Invasive Postural Therapy different from other treatments for lumbar spinal stenosis?

Non-Invasive Postural Therapy is unique because it focuses on adjusting posture and body alignment without surgery or medication, which can be less invasive and have fewer side effects compared to traditional treatments like surgery or pain medications.1112131415

Research Team

BB

Beth B. Hogans, MD

Principal Investigator

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

Eligibility Criteria

This trial is for older adult Veterans with lumbar spinal stenosis who experience back/leg pain when walking or standing. They must have had symptoms for over 3 months, tried non-surgical treatments, and be able to walk 50 feet unaided. Exclusions include previous back surgery for spinal stenosis, certain spine conditions like severe scoliosis, inflammatory diseases affecting the spine, and moderate to severe arthritis preventing walking.

Inclusion Criteria

My condition is diagnosed as Lumbar Spinal Stenosis.
My recent scans show I have Lumbar Spinal Stenosis at 1 or 2 levels.
My pain usually goes away within 5 minutes of sitting down.
See 12 more

Exclusion Criteria

I have had surgery on my lower back for spinal stenosis.
I have had a successful treatment for spinal stenosis in the last 3 months.
Bending backwards eases my lower back pain.
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DME and training to support continuous maintenance of flexion posture during the 6-week trial

6 weeks
Intermittent visits for actigraph and pedometer monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Non-Invasive Postural Therapy
Trial OverviewThe study tests a Non-Invasive Postural Therapy (NIPT) program designed to relieve symptoms of Lumbar Spinal Stenosis without surgery. It includes using a modified walker and changes in sleep positioning. Participants will be monitored for symptom relief and improved mobility.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: FeasibilityExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Findings from Research

In a study of 244 patients with lumbar spinal stenosis, 37% received physical therapy within the first 6 weeks, which was linked to a lower likelihood of needing surgery within one year (21% vs. 33%).
Physical therapy also led to greater improvements in physical functioning scores after 6 months and 1 year, although there were no significant changes in bodily pain or disability scores.
Associations between physical therapy and long-term outcomes for individuals with lumbar spinal stenosis in the SPORT study.Fritz, JM., Lurie, JD., Zhao, W., et al.[2023]
A case series of three patients with lumbar spinal stenosis (LSS) showed that a well-defined, outpatient manual physical therapy program can lead to significant improvements in disability, symptoms, and function within a short time frame, with benefits maintained for up to 18 months.
This noninvasive treatment approach emphasizes individualized care and avoids the potential adverse effects associated with invasive therapies or medications, highlighting its safety and efficacy for managing LSS.
Nonsurgical management of patients with lumbar spinal stenosis: a literature review and a case series of three patients managed with physical therapy.Whitman, JM., Flynn, TW., Fritz, JM.[2019]
A multidisciplinary conservative treatment program, including physiotherapy, behavioral therapy, and epidural injections, is effective for managing lumbar spinal stenosis (LSS) and should be prioritized before considering surgery.
Current literature lacks randomized clinical trials on non-surgical management of LSS, but existing studies support the use of epidural steroids as a beneficial component of conservative treatment.
[Conservative treatment of lumbar spinal stenosis--a review].Theodoridis, T., Krรคmer, J., Kleinert, H.[2019]

References

Associations between physical therapy and long-term outcomes for individuals with lumbar spinal stenosis in the SPORT study. [2023]
Nonsurgical management of patients with lumbar spinal stenosis: a literature review and a case series of three patients managed with physical therapy. [2019]
[Conservative treatment of lumbar spinal stenosis--a review]. [2019]
A non-surgical approach to the management of lumbar spinal stenosis: a prospective observational cohort study. [2018]
Supervised physical therapy versus surgery for patients with lumbar spinal stenosis: a propensity score-matched analysis. [2022]
Beliefs, perceptions and practices of chiropractors and patients about mitigation strategies for benign adverse events after spinal manipulation therapy. [2023]
Defining adverse events in manual therapies: a modified Delphi consensus study. [2022]
Exploring approaches to patient safety: the case of spinal manipulation therapy. [2022]
Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Definition and classification for adverse events following spinal and peripheral joint manipulation and mobilization: A scoping review. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Effectiveness of Lifestyle Modification in Corrections of States Associated with Metabolic Syndrome. [2017]
12.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Non-medicamentous methods for the treatment of metabolic syndrome]. [2017]
New therapeutic perspectives in non-alcoholic steatohepatitis. [2018]
14.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Nutraceutical correction in the complex non-drug treatment of metabolic syndrome]. [2021]
The influence of diet therapeutic intervention on the sarcopenic index of patients with metabolic syndrome. [2022]