The Effect of AposTherapy on Pain and Function in a Non Specific Low Back Pain

Study Overview
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Brief Summary
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AposTherapy is a home based exercise program utilizing footwear that causes exercise with normal activity that may significantly improve function in patients with back pain since patients with back pain have altered mechanics of motion contributing or due to the presence of the conditions. Capitalizing on the reported excellent adherence and clinical benefit of ApostTherapy in patients with significant knee and back pain, we propose to evaluate this as a conservative treatment that may supplant/supplement traditional pain medications and physical therapy in an at-risk urban inner city population.

Detailed Description
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AposTherapy® is a home-based exercise program utilizing footwear that causes exercise with normal daily activity that may significantly improve function in patients with back pain in general, and specifically Axial Low Back Pain (NSLBP). Capitalizing on the reported excellent adherence and clinical benefit of Apos Therapy in patients with significant back pain, we propose to evaluate this as a conservative treatment that may supplant/supplement traditional pain medications and physical therapy in NSLBP population. A possible potential use of AposTherapy® as a replacement for traditional physical therapy may yield a less costly, more effective therapy with better adherence. Problems with traditional therapy include poor patient adherence to both outpatient and home therapy programs, the added cost of travel (which may be more than $100 per session for ambulette or access-a-ride for eligible patients), and the lack of continuation in an ongoing exercise program[6-8], all of which can lead to relapse and need for retreatment. Additionally, access to physical therapy is limited for many patients since there are not enough available outpatient therapy services to meet the needs of all patients. Finding an alternative exercise program that will increase adherence, decrease total therapy visits, and improve patient's outcomes with decreased dependence on pain medications is a high priority from both patient care and cost management perspectives. AposTherapy® potentially overcomes many of these issues by improving/modifying abnormal biomechanics (therefore decreasing pain), and providing an independent home-based exercise program utilizing footwear that causes exercise with normal activity by promoting perturbation. This biomechanical approach may significantly reduce pain and improve function in patients with nonspecific low back pain (NSLBP). Capitalizing on the reported excellent adherence and clinical benefit of AposTherapy® in patients with significant NSLBP, we propose to evaluate the biomechanical exercise (wearing an appropriately calibrated shoe at home for a prescribed amount of time each day) as a conservative treatment that may supplement or supplant traditional pain medications, interventional pain procedures and physical therapy in an at-risk urban inner city population with NSLBP.

Official Title
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The Effect of AposTherapy on Pain and Function in a Non Specific Low Back Pain Population. A Randomized Controlled Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: AposTherapy
* Other: Traditional Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: •Patients suffering from symptomatic axial lower back pain for at least 24 weeks. Patients with VAS pain score of ≥3cm (measured at baseline). Males and females between the ages of 30-85. 17<BMI<40 Ambulatory and active patients that can participate in a rehabilitation program that includes daily walking Stable medicine regimen (no recent changes to their pain medication within a month) Able to walk at least 50 meters and scored positive on the STEADI test (Supp. 1) Able to understand, read and sign the informed consent form English or Spanish speaking Exclusion Criteria: •Patients suffering from active inflammatory joint disease. Patients with diagnosis of neuromuscular disease. Patients with more than 3 falls in the last 52 weeks, OR any balance related fall with an injury in the last 52 weeks. Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure. Patients with a history of pathological osteoporotic fracture Patients with referred pain consistent with radicular etiology Patients with generalized body pain (both upper and lower extremities). No spine surgery within 24 weeks. No image guided lumbar intervention in the past 8 weeks. No major cardiovascular comorbidities (able to enroll in an active exercise program) Patient started on lipid lowering medication in last 12 weeks Any change in blood pressure medications No recent physical therapy for the back. (within the last 12 weeks) No active heart disease (ischemia or heart failure admissions within 24 weeks) and no active COPD (exacerbation within 24 weeks) No active malignancies on ongoing treatment Patient with neurological gait pattern. Patient requiring assistive device during gait analysis.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single blinded (evaluator), single-center, randomized controlled trial. Interventional and Control group with option for Control group to Cross over.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Physical Therapy<br>Up to 20 sessions of traditional physical therapy. | Other: Traditional Physical Therapy<br>* Up to 20 sessions of traditional physical therapy<br>|
| Experimental: AposTherapy<br>Treatment with at home AposTherapy with daily use of the shoe. | Device: AposTherapy<br>* AposTherapy® is a home-based exercise program utilizing footwear that causes exercise with normal daily activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function | Improvement in back pain measured and assessed with the Oswestry Disability Index (ODI). | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function | Pain and Function measured through PROMIS short forms | 1 year | 
| Pain medication consumption | medication consumption | 1 year | 
| Quality of life survey | Quality of life assessed with Short Form Health Survey questionnaire | 1 year | 
| Gait assessment | objective analysis of patients' gait assessed with a pressure mat to demonstrate stride length, velocity, and symmetry. | 1 year | 
| 6-min walk test | objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course | 1 year | 
| Dynamic balance | Measured by Berg balance test assessed with a questionnaire | 1 year | 
| Static balance | functional reach test assessed by physically testing the patient with a standardized set of instructions | 1 year | 
| Blood pressure | Change in blood pressure , physiological parameter | 1 year | 
| resting heart rate | change in resting heart rate , physiological parameter | 1 year | 
| Overall activity | overall activity measured as daily steps, through wristband devices | 1 year | 
| sleep patterns | Total sleep time measured in minutes through wristband activity monitor (FitBit) measured over one week | 1 year | 
| Visual Analog Scale (VAS) for pain measurement | questionnaire | 1 year | 
| Medication Consumption | Track increase or decrease in Medication consumption- assessed through patient interview and patent report | 1 year | 
| Medication Costs | Calculate monetary savings in Medication Costs- assessed through patient interview and prevailing market cost information | 1 year | 
| Hospitalization utilizations | Calculate the increase/decrease in hospital facility utilization - assessed with patient interview and health records. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oswestry, SF 36, Promis Pain and Function, Berg Balance