Purpose

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

Eligibility

Eligible Ages
Between 30 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
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.
Primary Purpose
Treatment
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.

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Matthew Bartels, MD, MPH
718-920-2751
mbartels@montefiore.org

More Details

Status
Recruiting
Sponsor
Montefiore Medical Center

Study Contact

Sewon Lee, MD
7189207590
sewlee@montefiore.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.