Non-Invasive Postural Therapy for Lumbar Spinal Stenosis

(LSS-NIPT Trial)

Overseen By Beth B Hogans, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Low back surgery, Lumbar fracture, Scoliosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a non-surgical approach to assist older Veterans with lumbar spinal stenosis, a condition that narrows spaces in the lower spine, causing pain and difficulty walking. The focus is on using techniques like modified walking aids and sleep positions to determine if they can ease symptoms and improve mobility. Participants will provide feedback on any challenges faced with this new method of non-invasive postural therapy. Veterans who have experienced back or leg pain for more than three months, which eases when sitting down, and who can walk 50 feet without aid, might be suitable candidates. As an unphased trial, this study offers Veterans the chance to contribute to innovative research that may enhance quality of life without surgery.

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 prior data suggests that this non-invasive postural therapy is safe for older adults with lumbar spinal stenosis?

Research has shown that non-surgical treatments, such as physical therapy, can be safe and effective for people with lumbar spinal stenosis (LSS). One study found that patients who received hands-on therapy and customized exercises experienced significant symptom improvement. This finding suggests that non-invasive methods, like postural therapy, might be well-tolerated.

Non-invasive treatments usually have fewer side effects than surgery. They often involve changing body positions or movements to relieve spinal pressure. Other studies report that these methods can improve walking ability and reduce symptoms without major risks.

While specific data on side effects from postural therapy alone is lacking, the safety of non-surgical treatments for LSS is generally considered good. This suggests that non-invasive postural therapy is likely safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about non-invasive postural therapy for lumbar spinal stenosis because it offers a fresh approach compared to traditional treatments like medications, physical therapy, or surgery. This therapy focuses on maintaining a specific posture to alleviate symptoms, which is a non-invasive method that doesn't rely on drugs or surgical intervention. Additionally, patients are trained to maintain a flexed posture throughout their daily activities, which could lead to improved mobility and reduced pain without the risks associated with more invasive procedures. This innovative approach could provide relief for patients seeking alternatives to conventional treatments.

What evidence suggests that this non-invasive postural therapy is effective for lumbar spinal stenosis?

Research shows that nonsurgical treatments, such as non-invasive postural therapy, can help people with lumbar spinal stenosis (LSS) walk better and experience less pain. Studies indicate that these methods, including changes in daily posture, improve symptoms and function. For example, combining hands-on therapy with personalized exercises led to noticeable improvements in pain levels and walking ability. This trial will focus on non-invasive postural therapy, suggesting that adjusting movement and rest during the day might help manage LSS without surgery. Non-invasive methods may be especially beneficial for those who cannot or prefer not to undergo surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Beth B. Hogans, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Non-Invasive Postural Therapy

Trial Overview The 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.

How Is the Trial Designed?

Group I: Feasibility Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a 3-month study involving 30 obese patients, lifestyle modification therapy significantly reduced the risk of cardiovascular events, a key indicator of metabolic syndrome.

The therapy led to improvements in various metabolic syndrome components, including normalized blood pressure in 53% of patients, improved lipid and carbohydrate levels in 46% and 44% respectively, reduced hepatic steatosis in 56%, and resolved hemostatic disturbances in 67%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Lifestyle Modification in Corrections of States Associated with Metabolic Syndrome. Kseneva, SI., Borodulina, EV., Trifonova, OY., et al.[2017]

Non-medicamentous treatments for metabolic syndrome, such as remedial gymnastics, physiotherapy, and psychotherapy, can reduce the need for pharmaceuticals and enhance the effectiveness of drug therapies.

These methods are particularly important for addressing weight loss, which is a critical and early sign of metabolic syndrome, and the paper outlines specific indications and contraindications for each treatment modality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Non-medicamentous methods for the treatment of metabolic syndrome]. Khutsishvili, MB., Rapoport, SI.[2017]

In a 12-month study involving 110 patients with metabolic syndrome, those who combined diet therapy with sports (DTSG) showed the most significant improvements in body mass index (BMI) and insulin resistance, as measured by the HOMA index.

The diet therapy group (DTG) also experienced significant reductions in BMI and HOMA index, indicating that dietary changes alone can effectively improve metabolic control in patients with metabolic syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of diet therapeutic intervention on the sarcopenic index of patients with metabolic syndrome. Ghitea, TC., Vlad, S., Birle, D., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Conservative treatment of lumbar spinal stenosis--a review]. Theodoridis, T., Krämer, J., Kleinert, H.[2019]

In a study of 55 patients with lumbar spinal stenosis, a novel non-surgical treatment involving distraction manipulation and neural mobilization led to a significant mean improvement in disability of 5.1 points, with 66.7% of patients experiencing clinically meaningful improvement.

Long-term follow-up (average 16.5 months) showed sustained benefits, with a mean patient-rated improvement of 75.6% and clinically meaningful reductions in pain intensity, indicating that this non-surgical approach is both effective and safe, as only two patients required surgery afterward.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A non-surgical approach to the management of lumbar spinal stenosis: a prospective observational cohort study. Murphy, DR., Hurwitz, EL., Gregory, AA., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 significant number of patients (55%) reported experiencing benign adverse events (AEs) like pain and stiffness after spinal manipulative therapy (SMT), highlighting the need for effective management strategies.

While most chiropractors believe in the occurrence of benign AEs and attempt mitigation strategies, only a small percentage of patients feel these strategies are implemented, indicating a gap in communication and patient education that could enhance care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beliefs, perceptions and practices of chiropractors and patients about mitigation strategies for benign adverse events after spinal manipulation therapy. Funabashi, M., Pohlman, KA., Goldsworthy, R., et al.[2023]

A consensus definition for adverse events in manual therapy was established through a modified Delphi survey with 50 experts, highlighting the need for clear classification to understand the incidence and prevalence of these events.

The agreed classification includes 'Major' adverse events that are serious and require further treatment, 'Moderate' events that are less severe, and 'Mild' events that are transient and non-serious, emphasizing the importance of context in evaluating adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining adverse events in manual therapies: a modified Delphi consensus study. Carnes, D., Mullinger, B., Underwood, M.[2022]

In a study involving 241 elderly participants undergoing spinal manipulative therapy (SMT) and exercise for chronic neck pain, 130 reported non-serious adverse events (AEs), highlighting the prevalence of musculoskeletal issues associated with these treatments.

Participants in the supervised exercise group reported three times more AEs compared to those receiving home exercise alone, indicating that while SMT and exercise can be effective, they also carry a risk of AEs that should be considered in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial. Maiers, M., Evans, R., Hartvigsen, J., et al.[2022]

A scoping review of 98 studies revealed a lack of a common definition or classification system for adverse events following spinal and peripheral joint manipulation, which complicates patient safety efforts.

The review identified various descriptors for adverse events, such as causality and symptom severity, highlighting the need for a standardized approach to improve clarity and safety in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definition and classification for adverse events following spinal and peripheral joint manipulation and mobilization: A scoping review. Funabashi, M., Gorrell, LM., Pohlman, KA., et al.[2022]

The primary approach to managing non-alcoholic steatohepatitis (NASH) involves lifestyle changes, particularly adopting a Mediterranean diet and increasing physical activity, which are considered first-line therapies.

For patients who do not respond to lifestyle interventions, several drug therapies are being developed, targeting various mechanisms such as inflammation and fibrosis, while bariatric surgery is an option for morbidly obese patients who fail to lose weight through other means.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New therapeutic perspectives in non-alcoholic steatohepatitis. Ampuero, J., Sánchez-Torrijos, Y., Aguilera, V., et al.[2018]

A 4-week study involving 120 patients with metabolic syndrome showed that a low-calorie diet combined with physical exercise significantly reduced body weight and fat mass, while also improving lipid profiles by lowering cholesterol and triglycerides.

The addition of nutraceuticals for gut microbiome correction and hepatic protection further enhanced these effects, leading to greater reductions in leptin and insulin levels, indicating a more effective approach to managing metabolic syndrome without risking muscle loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutraceutical correction in the complex non-drug treatment of metabolic syndrome]. Agasarov, LG., Apkhanova, TV., Sergeev, VN., et al.[2021]

In a study of 224 patients with lumbar spinal stenosis, supervised physical therapy showed similar effectiveness to surgery after matching for baseline characteristics, suggesting it can be a viable first-line treatment.

Patients who underwent surgery had greater improvements in certain quality of life measures, but physical therapy is recommended to avoid surgical complications and reduce healthcare costs, especially for mild to moderate cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised physical therapy versus surgery for patients with lumbar spinal stenosis: a propensity score-matched analysis. Minetama, M., Kawakami, M., Teraguchi, M., et al.[2022]

The study involved 56 interviews with health professionals in Canada, revealing a significant disagreement about the actual risks associated with spinal manipulation therapy (SMT), indicating a need for clearer communication and understanding of safety issues.

Participants identified barriers to implementing an incident reporting system for SMT, suggesting that collaboration among different health professions is essential to improve patient safety and learn from adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring approaches to patient safety: the case of spinal manipulation therapy. Rozmovits, L., Mior, S., Boon, H.[2022]

Citations

1. withpower.com withpower.com/trial/phase-spinal-stenosis-1-2024-2b01d

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 ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK594346/

Comparing the Effectiveness of Nonsurgical Treatments for ... The combination of manual therapy and individualized exercise led to significantly greater improvement in SSS and SPWT at 2 months, whereas GE led to ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2720073

Comparative Clinical Effectiveness of Nonsurgical ... Although LSS is a chronic degenerative condition, patients with LSS can show improvement in walking capacity with nonsurgical approaches.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1526590021001887

Non-Surgical Interventions for Lumbar Spinal Stenosis ... We developed this guideline to present the evidence and provide clinical recommendations on nonsurgical management of patients with LSS causing NC.

5. mayoclinic.org mayoclinic.org/medical-professionals/physical-medicine-rehabilitation/news/nonsurgical-treatment-options-for-lumbar-spinal-stenosis/mac-20533117

Nonsurgical treatment options for lumbar spinal stenosis Management options for LSS include watchful waiting, physical therapy, equipment and modalities, medications, injections, and surgical referral.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10637222/

Lumbar Spinal Stenosis and Minimally Invasive Lumbar ... MILD is an emerging minimally invasive treatment for LSS. It is an image-guided percutaneous procedure designed to debulk hypertrophied ligamentum flavum.