Low Back PainAposBackNCT03167671
The Effect of AposTherapy on Pain and Function in a Non Specific Low Back Pain
A study testing AposTherapy and Traditional Physical Therapy in people with Low Back Pain, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- AposTherapy and Traditional Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2017to 28 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •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)
Show all 9Show fewer
- 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
Who cannot join
- •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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- AposTherapy, Traditional Physical Therapy
- Keywords
- Oswestry, SF 36, Promis Pain and Function, Berg Balance
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AposTherapyDevice
AposTherapy® is a home-based exercise program utilizing footwear that causes exercise with normal daily activity
Traditional Physical TherapyOther
Up to 20 sessions of traditional physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Traditional Physical Therapy | Active comparator | Up to 20 sessions of traditional physical therapy. Receives: Other: Traditional Physical Therapy |
| AposTherapy | Experimental | Treatment with at home AposTherapy with daily use of the shoe. Receives: Device: AposTherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function
Improvement in back pain measured and assessed with the Oswestry Disability Index (ODI).
Measured: 1 Year
Secondary outcomes (15)
PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function
Pain and Function measured through PROMIS short forms
Measured: 1 year
Pain medication consumption
medication consumption
Measured: 1 year
Quality of life survey
Quality of life assessed with Short Form Health Survey questionnaire
Measured: 1 year
Gait assessment
objective analysis of patients' gait assessed with a pressure mat to demonstrate stride length, velocity, and symmetry.
Measured: 1 year
6-min walk test
objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course
Measured: 1 year
Dynamic balance
Measured by Berg balance test assessed with a questionnaire
Measured: 1 year
Static balance
functional reach test assessed by physically testing the patient with a standardized set of instructions
Measured: 1 year
Blood pressure
Change in blood pressure , physiological parameter
Measured: 1 year
resting heart rate
change in resting heart rate , physiological parameter
Measured: 1 year
Overall activity
overall activity measured as daily steps, through wristband devices
Measured: 1 year
sleep patterns
Total sleep time measured in minutes through wristband activity monitor (FitBit) measured over one week
Measured: 1 year
Visual Analog Scale (VAS) for pain measurement
questionnaire
Measured: 1 year
Medication Consumption
Track increase or decrease in Medication consumption- assessed through patient interview and patent report
Measured: 1 year
Medication Costs
Calculate monetary savings in Medication Costs- assessed through patient interview and prevailing market cost information
Measured: 1 year
Hospitalization utilizations
Calculate the increase/decrease in hospital facility utilization - assessed with patient interview and health records.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start15 Aug 2017
- Primary completion28 Jan 2023
- Study completion28 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded (evaluator), single-center, randomized controlled trial. Interventional and Control group with option for Control group to Cross over.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Apos Medical and Sports Technology Ltd.
- Responsible party
- Sponsor
- Investigators
- Matthew N Bartels, MD, MPH, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167671
- Sponsor's protocol ID
- 2016-6701
- Acronym
- AposBack
- Status last verified
- May 2024
- First submitted
- 21 Mar 2017
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19204216Meucci 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.
PubMed 26487293Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
PubMed 14710506Hayden 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.
PubMed 15867409Tsao 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.
PubMed 17476489Hides 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.
PubMed 11389408Keefe 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.
PubMed 3157094
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of AposTherapy on Pain and Function in a Non Specific Low Back Pain Population. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03167671
- Acronym / sponsor ID
- AposBack / 2016-6701
- Conditions
- Low Back Pain
- Keywords
- Oswestry, SF 36, Promis Pain and Function, Berg Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Apos Medical and Sports Technology Ltd.
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 28 Jan 2023 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blinded (evaluator), single-center, randomized controlled trial. Interventional and Control group with option for Control group to Cross over.
| Arm | Type | Receives |
|---|---|---|
| Traditional Physical Therapy | Active comparator | Other: Traditional Physical TherapyUp to 20 sessions of traditional physical therapy. |
| AposTherapy | Experimental | Device: AposTherapyTreatment with at home AposTherapy with daily use of the shoe. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- •Patients suffering from symptomatic axial lower back pain for at least 24 weeks.
Key exclusion criteria (17 listed)
- •Patients suffering from active inflammatory joint disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AposTherapyAposTherapy® is a home-based exercise program utilizing footwear that causes exercise with normal daily activity | Device | AposTherapy |
| Traditional Physical TherapyUp to 20 sessions of traditional physical therapy | Other | Traditional Physical Therapy |
Primary outcome
Function
Time frame: 1 Year
Improvement in back pain measured and assessed with the Oswestry Disability Index (ODI).
15 secondary outcomes
PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function
Time frame: 1 year
Pain medication consumption
Time frame: 1 year
Quality of life survey
Time frame: 1 year
Gait assessment
Time frame: 1 year
6-min walk test
Time frame: 1 year
Dynamic balance
Time frame: 1 year
Static balance
Time frame: 1 year
Blood pressure
Time frame: 1 year
resting heart rate
Time frame: 1 year
Overall activity
Time frame: 1 year
sleep patterns
Time frame: 1 year
Visual Analog Scale (VAS) for pain measurement
Time frame: 1 year
Medication Consumption
Time frame: 1 year
Medication Costs
Time frame: 1 year
Hospitalization utilizations
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Background: PubMed 19204216Freburger 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.
- Background: PubMed 26487293Meucci 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.
- Background: PubMed 14710506Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
- Background: PubMed 15867409Hayden 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.
- Background: PubMed 17476489Tsao 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.
- Background: PubMed 11389408Hides 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.
- Background: PubMed 3157094Keefe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew N Bartels, MD, MPH principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AposTherapy and Traditional Physical Therapy in people with Low Back Pain, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03167671, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.