ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03167671
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
Apos Medical and Sports Technology Ltd.
Information provided by (Responsible Party):
Matthew Bartels, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: AposTherapy Other: Traditional Physical Therapy Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 147 participants
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
Official Title: The Effect of AposTherapy on Pain and Function in a Non Specific Low Back Pain Population. A Randomized Controlled Trial
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : August 14, 2018
Estimated Study Completion Date : August 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Traditional Physical Therapy
Up to 20 sessions of traditional physical therapy.
Other: Traditional Physical Therapy
Up to 20 sessions of traditional physical therapy

Experimental: AposTherapy
Treatment with at home AposTherapy with daily use of the shoe.
Device: AposTherapy
AposTherapy® is a home-based exercise program utilizing footwear that causes exercise with normal daily activity




Primary Outcome Measures :
  1. Function [ Time Frame: 1 Year ]
    Improvement in back pain measured and assessed with the Oswestry Disability Index (ODI).


Secondary Outcome Measures :
  1. PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function [ Time Frame: 1 year ]
    Pain and Function measured through PROMIS short forms

  2. Pain medication consumption [ Time Frame: 1 year ]
    medication consumption

  3. Quality of life [ Time Frame: 1 year ]
    Quality of life assessed with SF-36(Short Form Health Survey) questionnaire

  4. Gait assessment [ Time Frame: 1 year ]
    objective analysis of patients' gait assessed with a pressure mat to demonstrate stride length, velocity, and symmetry.

  5. 6-min walk test [ Time Frame: 1 year ]
    objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course

  6. Dynamic balance [ Time Frame: 1 year ]
    Measured by Berg balance test assessed with a questionnaire

  7. Static balance [ Time Frame: 1 year ]
    functional reach test assessed by physically testing the patient with a standardized set of instructions

  8. Blood pressure [ Time Frame: 1 year ]
    Change in blood pressure , physiological parameter

  9. resting heart rate [ Time Frame: 1 year ]
    change in resting heart rate , physiological parameter

  10. Overall activity [ Time Frame: 1 year ]
    overall activity measured as daily steps, through wristband devices

  11. sleep patterns [ Time Frame: 1 year ]
    Total sleep time measured in minutes through wristband activity monitor (FitBit) measured over one week

  12. Visual Analog Scale (VAS) for pain measurement [ Time Frame: 1 year ]
    questionnaire

  13. Medication Consumption [ Time Frame: 1 year ]
    Track increase or decrease in Medication consumption- assessed through patient interview and patent report

  14. Medication Costs [ Time Frame: 1 year ]
    Calculate monetary savings in Medication Costs- assessed through patient interview and prevailing market cost information

  15. Hospitalization utilizations [ Time Frame: 1 year ]
    Calculate the increase/decrease in hospital facility utilization - assessed with patient interview and health records.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167671


Contacts
Contact: Sewon Lee, MD 7189207590 sewlee@montefiore.org
Contact: Matthew N Bartels, MD, MPH 7189202751 mbartels@montefiore.org

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Matthew Bartels, MD, MPH    718-920-2751    mbartels@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Apos Medical and Sports Technology Ltd.
Investigators
Principal Investigator: Matthew N Bartels, MD, MPH Montefiore Medical Center

Study Data/Documents: Book  This link exits the ClinicalTrials.gov site
Identifier: ISBN-10: 1886039224

Publications:
Responsible Party: Matthew Bartels, Professor and Chairman of Rehabilitation Medicine Albert Einstein College of Medicine Chairman, Department of Rehabilitation Medicine Montefiore Medical Center, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03167671     History of Changes
Other Study ID Numbers: 2016-6701
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Matthew Bartels, Montefiore Medical Center:
Oswestry
SF 36
Promis Pain and Function
Berg Balance

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms