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.
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.
AposTherapy® is a home-based exercise program utilizing footwear that causes exercise with normal daily activity
Up to 20 sessions of traditional physical therapy
Montefiore Medical Center
The Bronx, New York, United States
Function
Improvement in back pain measured and assessed with the Oswestry Disability Index (ODI).
Time frame: 1 Year
PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function
Pain and Function measured through PROMIS short forms
Time frame: 1 year
Pain medication consumption
medication consumption
Time frame: 1 year
Quality of life survey
Quality of life assessed with Short Form Health Survey questionnaire
Time frame: 1 year
Gait assessment
objective analysis of patients' gait assessed with a pressure mat to demonstrate stride length, velocity, and symmetry.
Time frame: 1 year
6-min walk test
objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course
Time frame: 1 year
Dynamic balance
Measured by Berg balance test assessed with a questionnaire
Time frame: 1 year
Static balance
functional reach test assessed by physically testing the patient with a standardized set of instructions
Time frame: 1 year
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
164
Blood pressure
Change in blood pressure , physiological parameter
Time frame: 1 year
resting heart rate
change in resting heart rate , physiological parameter
Time frame: 1 year
Overall activity
overall activity measured as daily steps, through wristband devices
Time frame: 1 year
sleep patterns
Total sleep time measured in minutes through wristband activity monitor (FitBit) measured over one week
Time frame: 1 year
Visual Analog Scale (VAS) for pain measurement
questionnaire
Time frame: 1 year
Medication Consumption
Track increase or decrease in Medication consumption- assessed through patient interview and patent report
Time frame: 1 year
Medication Costs
Calculate monetary savings in Medication Costs- assessed through patient interview and prevailing market cost information
Time frame: 1 year
Hospitalization utilizations
Calculate the increase/decrease in hospital facility utilization - assessed with patient interview and health records.
Time frame: 1 year