Clinical trial NCT03167671: The Effect of AposTherapy on Pain and Function in a Non Specific Low Back Pain
Official title: The Effect of AposTherapy on Pain and Function in a Non Specific Low Back Pain Population. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Oswestry
SF 36
Promis Pain and Function
Berg Balance
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Apos Medical and Sports Technology Ltd.
First posted: 2017-05-30
Enrollment: 164
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Primary outcomes:
measure: Function
timeFrame: 1 Year
Secondary outcomes:
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function
timeFrame: 1 year
measure: Pain medication consumption
timeFrame: 1 year
measure: Quality of life survey
timeFrame: 1 year
measure: Gait assessment
timeFrame: 1 year
measure: 6-min walk test
timeFrame: 1 year
measure: Dynamic balance
timeFrame: 1 year
measure: Static balance
timeFrame: 1 year
measure: Blood pressure
timeFrame: 1 year
measure: resting heart rate
timeFrame: 1 year
measure: Overall activity
timeFrame: 1 year
measure: sleep patterns
timeFrame: 1 year
measure: Visual Analog Scale (VAS) for pain measurement
timeFrame: 1 year
measure: Medication Consumption
timeFrame: 1 year
measure: Medication Costs
timeFrame: 1 year
measure: Hospitalization utilizations
timeFrame: 1 year
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Matthew N Bartels, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
citation: 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.
citation: 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.
citation: 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.
citation: 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.