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

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{11 12 13 14 15}

Research Team

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.

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

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 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.

Participant Groups

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+

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.

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 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 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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Associations between physical therapy and long-term outcomes for individuals with lumbar spinal stenosis in the SPORT study. [2023]

2. United States 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. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Conservative treatment of lumbar spinal stenosis--a review]. [2019]

4. England pubmed.ncbi.nlm.nih.gov

A non-surgical approach to the management of lumbar spinal stenosis: a prospective observational cohort study. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Supervised physical therapy versus surgery for patients with lumbar spinal stenosis: a propensity score-matched analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Beliefs, perceptions and practices of chiropractors and patients about mitigation strategies for benign adverse events after spinal manipulation therapy. [2023]

7. Scotland pubmed.ncbi.nlm.nih.gov

Defining adverse events in manual therapies: a modified Delphi consensus study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Exploring approaches to patient safety: the case of spinal manipulation therapy. [2022]

9. Scotland pubmed.ncbi.nlm.nih.gov

Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Definition and classification for adverse events following spinal and peripheral joint manipulation and mobilization: A scoping review. [2022]

11. United States pubmed.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]

13. Spain pubmed.ncbi.nlm.nih.gov

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]

15. Romania pubmed.ncbi.nlm.nih.gov

The influence of diet therapeutic intervention on the sarcopenic index of patients with metabolic syndrome. [2022]