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 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Device: AposTherapy Other: Traditional Physical Therapy||Not Applicable|
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|
|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.|
|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|
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
Treatment with at home AposTherapy with daily use of the shoe.
AposTherapy® is a home-based exercise program utilizing footwear that causes exercise with normal daily activity
- Function [ Time Frame: 1 Year ]Improvement in back pain measured and assessed with the Oswestry Disability Index (ODI).
- 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.
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
|Contact: Sewon Lee, MDfirstname.lastname@example.org|
|Contact: Matthew N Bartels, MD, MPHemail@example.com|
|United States, New York|
|Montefiore Medical Center||Recruiting|
|Bronx, New York, United States, 10467|
|Contact: Matthew Bartels, MD, MPH 718-920-2751 firstname.lastname@example.org|
|Principal Investigator:||Matthew N Bartels, MD, MPH||Montefiore Medical Center|