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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Traditional Physical Therapy; Device: AposTherapy

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
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Apos Medical and Sports Technology Ltd.
• Investigators: Principal Investigator: Matthew N Bartels, MD, MPH, Montefiore Medical Center

Publications and helpful links

General Publications

• Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.
• Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.
• Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
• Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005 May 3;142(9):765-75. doi: 10.7326/0003-4819-142-9-200505030-00013.
• Tsao H, Hodges PW. Immediate changes in feedforward postural adjustments following voluntary motor training. Exp Brain Res. 2007 Aug;181(4):537-46. doi: 10.1007/s00221-007-0950-z. Epub 2007 May 3.
• Hides JA, Jull GA, Richardson CA. Long-term effects of specific stabilizing exercises for first-episode low back pain. Spine (Phila Pa 1976). 2001 Jun 1;26(11):E243-8. doi: 10.1097/00007632-200106010-00004.
• Keefe FJ, Hill RW. An objective approach to quantifying pain behavior and gait patterns in low back pain patients. Pain. 1985 Feb;21(2):153-161. doi: 10.1016/0304-3959(85)90285-4.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Estimated): January 28, 2024
• Study Completion (Estimated): January 28, 2024

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Oswestry; SF 36; Promis Pain and Function; Berg Balance
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2016-6701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Book
   Information identifier: ISBN-10: 1886039224
2. NAtional statistical Report
   Information comments: year 2015

Drug and device information, study documents

• 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