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

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ClinicalTrials.gov Identifier: NCT03167671
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : March 11, 2020
Sponsor:
Collaborator:
Apos Medical and Sports Technology Ltd.
Information provided by (Responsible Party):
Matthew Bartels, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE March 21, 2017
First Posted Date  ICMJE May 30, 2017
Last Update Posted Date March 11, 2020
Actual Study Start Date  ICMJE August 15, 2017
Estimated Primary Completion Date August 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
Function [ Time Frame: 1 Year ]
Improvement in back pain measured and assessed with the Oswestry Disability Index (ODI).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
  • PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function [ Time Frame: 1 year ]
    Pain and Function measured through PROMIS short forms
  • Pain medication consumption [ Time Frame: 1 year ]
    medication consumption
  • Quality of life [ Time Frame: 1 year ]
    Quality of life assessed with SF-36(Short Form Health Survey) questionnaire
  • Gait assessment [ Time Frame: 1 year ]
    objective analysis of patients' gait assessed with a pressure mat to demonstrate stride length, velocity, and symmetry.
  • 6-min walk test [ Time Frame: 1 year ]
    objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course
  • Dynamic balance [ Time Frame: 1 year ]
    Measured by Berg balance test assessed with a questionnaire
  • Static balance [ Time Frame: 1 year ]
    functional reach test assessed by physically testing the patient with a standardized set of instructions
  • Blood pressure [ Time Frame: 1 year ]
    Change in blood pressure , physiological parameter
  • resting heart rate [ Time Frame: 1 year ]
    change in resting heart rate , physiological parameter
  • Overall activity [ Time Frame: 1 year ]
    overall activity measured as daily steps, through wristband devices
  • sleep patterns [ Time Frame: 1 year ]
    Total sleep time measured in minutes through wristband activity monitor (FitBit) measured over one week
  • Visual Analog Scale (VAS) for pain measurement [ Time Frame: 1 year ]
    questionnaire
  • Medication Consumption [ Time Frame: 1 year ]
    Track increase or decrease in Medication consumption- assessed through patient interview and patent report
  • Medication Costs [ Time Frame: 1 year ]
    Calculate monetary savings in Medication Costs- assessed through patient interview and prevailing market cost information
  • Hospitalization utilizations [ Time Frame: 1 year ]
    Calculate the increase/decrease in hospital facility utilization - assessed with patient interview and health records.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of AposTherapy on Pain and Function in a Non Specific Low Back Pain
Official Title  ICMJE The Effect of AposTherapy on Pain and Function in a Non Specific Low Back Pain Population. A Randomized Controlled Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Single blinded (evaluator), single-center, randomized controlled trial. Interventional and Control group with option for Control group to Cross over.
Masking: Single (Outcomes Assessor)
Masking Description:
The outcomes assessor is the only one masked in the study. They are independent of the randomization, trial coordination, and care providers.
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Device: AposTherapy
    AposTherapy® is a home-based exercise program utilizing footwear that causes exercise with normal daily activity
  • Other: Traditional Physical Therapy
    Up to 20 sessions of traditional physical therapy
Study Arms  ICMJE
  • Active Comparator: Traditional Physical Therapy
    Up to 20 sessions of traditional physical therapy.
    Intervention: Other: Traditional Physical Therapy
  • Experimental: AposTherapy
    Treatment with at home AposTherapy with daily use of the shoe.
    Intervention: Device: AposTherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2017)
147
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 14, 2021
Estimated Primary Completion Date August 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sewon Lee, MD 7189207590 sewlee@montefiore.org
Contact: Matthew N Bartels, MD, MPH 7189202751 mbartels@montefiore.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03167671
Other Study ID Numbers  ICMJE 2016-6701
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Matthew Bartels, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Apos Medical and Sports Technology Ltd.
Investigators  ICMJE
Principal Investigator: Matthew N Bartels, MD, MPH Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP