NCT03167671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2023

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

5.5 years

First QC Date

March 21, 2017

Last Update Submit

May 2, 2024

Conditions

Low Back Pain

Keywords

OswestrySF 36Promis Pain and FunctionBerg Balance

Outcome Measures

Primary Outcomes (1)

  • Function

    Improvement in back pain measured and assessed with the Oswestry Disability Index (ODI).

    1 Year

Secondary Outcomes (15)

  • PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function

    1 year

  • Pain medication consumption

    1 year

  • Quality of life survey

    1 year

  • Gait assessment

    1 year

  • 6-min walk test

    1 year

  • +10 more secondary outcomes

Study Arms (2)

Traditional Physical Therapy

ACTIVE COMPARATOR

Up to 20 sessions of traditional physical therapy.

Other: Traditional Physical Therapy

AposTherapy

EXPERIMENTAL

Treatment with at home AposTherapy with daily use of the shoe.

Device: AposTherapy

Interventions

AposTherapyDEVICE

AposTherapy® is a home-based exercise program utilizing footwear that causes exercise with normal daily activity

AposTherapy
Traditional Physical TherapyOTHER

Up to 20 sessions of traditional physical therapy

Traditional Physical Therapy

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • \<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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (7)

  • 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.

    PMID: 19204216BACKGROUND

  • 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.

    PMID: 26487293BACKGROUND

  • Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.

    PMID: 14710506BACKGROUND

  • 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.

    PMID: 15867409BACKGROUND

  • 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.

    PMID: 17476489BACKGROUND

  • 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.

    PMID: 11389408BACKGROUND

  • 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.

    PMID: 3157094BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Matthew N Bartels, MD, MPH

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor is the only one masked in the study. They are independent of the randomization, trial coordination, and care providers.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single blinded (evaluator), single-center, randomized controlled trial. Interventional and Control group with option for Control group to Cross over.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2017

First Posted

May 30, 2017

Study Start

August 15, 2017

Primary Completion

January 28, 2023

Study Completion

January 28, 2023

Last Updated

May 6, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Book (ISBN-10: 1886039224)Access

Locations

US(1)