Brief Summary
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.
Brief Title
The Effect of AposTherapy on Pain and Function in a Non Specific Low Back Pain
Detailed Description
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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Low Back Pain
Eligibility Criteria
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.
* •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.
Inclusion Criteria
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
* •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
Gender
All
Gender Based
false
Keywords
Oswestry
SF 36
Promis Pain and Function
Berg Balance
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
85 Years
Minimum Age
30 Years
NCT Id
NCT03167671
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2016-6701
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
The Effect of AposTherapy on Pain and Function in a Non Specific Low Back Pain Population. A Randomized Controlled Trial
Primary Outcomes
Outcome Description
Improvement in back pain measured and assessed with the Oswestry Disability Index (ODI).
Outcome Measure
Function
Outcome Time Frame
1 Year
Secondary Outcomes
Outcome Description
Pain and Function measured through PROMIS short forms
Outcome Time Frame
1 year
Outcome Measure
PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function
Outcome Description
medication consumption
Outcome Time Frame
1 year
Outcome Measure
Pain medication consumption
Outcome Description
Quality of life assessed with Short Form Health Survey questionnaire
Outcome Time Frame
1 year
Outcome Measure
Quality of life survey
Outcome Description
objective analysis of patients' gait assessed with a pressure mat to demonstrate stride length, velocity, and symmetry.
Outcome Time Frame
1 year
Outcome Measure
Gait assessment
Outcome Description
objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course
Outcome Time Frame
1 year
Outcome Measure
6-min walk test
Outcome Description
Measured by Berg balance test assessed with a questionnaire
Outcome Time Frame
1 year
Outcome Measure
Dynamic balance
Outcome Description
functional reach test assessed by physically testing the patient with a standardized set of instructions
Outcome Time Frame
1 year
Outcome Measure
Static balance
Outcome Description
Change in blood pressure , physiological parameter
Outcome Time Frame
1 year
Outcome Measure
Blood pressure
Outcome Description
change in resting heart rate , physiological parameter
Outcome Time Frame
1 year
Outcome Measure
resting heart rate
Outcome Description
overall activity measured as daily steps, through wristband devices
Outcome Time Frame
1 year
Outcome Measure
Overall activity
Outcome Description
Total sleep time measured in minutes through wristband activity monitor (FitBit) measured over one week
Outcome Time Frame
1 year
Outcome Measure
sleep patterns
Outcome Description
questionnaire
Outcome Time Frame
1 year
Outcome Measure
Visual Analog Scale (VAS) for pain measurement
Outcome Description
Track increase or decrease in Medication consumption- assessed through patient interview and patent report
Outcome Time Frame
1 year
Outcome Measure
Medication Consumption
Outcome Description
Calculate monetary savings in Medication Costs- assessed through patient interview and prevailing market cost information
Outcome Time Frame
1 year
Outcome Measure
Medication Costs
Outcome Description
Calculate the increase/decrease in hospital facility utilization - assessed with patient interview and health records.
Outcome Time Frame
1 year
Outcome Measure
Hospitalization utilizations
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
85
Minimum Age Number (converted to Years and rounded down)
30
Investigators
Investigator Type
Principal Investigator
Investigator Name
Matthew Bartels
Investigator Email
mbartels@montefiore.org