The Effect of AposTherapy on Pain and Function in a Non Specific Low Back Pain

Low Back Pain Clinical Trial

— AposBack  

Official title:

The Effect of AposTherapy on Pain and Function in a Non Specific Low Back Pain Population. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03167671
• Other study ID #: 2016-6701
• Status: Completed
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: January 28, 2023

Study information

• Verified date: May 2024
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: January 28, 2023
• Est. primary completion date: January 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Other:
• Traditional Physical Therapy
Up to 20 sessions of traditional physical therapy

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Apos Medical and Sports Technology Ltd.

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function	Improvement in back pain measured and assessed with the Oswestry Disability Index (ODI).	1 Year
Secondary	PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function	Pain and Function measured through PROMIS short forms	1 year
Secondary	Pain medication consumption	medication consumption	1 year
Secondary	Quality of life survey	Quality of life assessed with Short Form Health Survey questionnaire	1 year
Secondary	Gait assessment	objective analysis of patients' gait assessed with a pressure mat to demonstrate stride length, velocity, and symmetry.	1 year
Secondary	6-min walk test	objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course	1 year
Secondary	Dynamic balance	Measured by Berg balance test assessed with a questionnaire	1 year
Secondary	Static balance	functional reach test assessed by physically testing the patient with a standardized set of instructions	1 year
Secondary	Blood pressure	Change in blood pressure , physiological parameter	1 year
Secondary	resting heart rate	change in resting heart rate , physiological parameter	1 year
Secondary	Overall activity	overall activity measured as daily steps, through wristband devices	1 year
Secondary	sleep patterns	Total sleep time measured in minutes through wristband activity monitor (FitBit) measured over one week	1 year
Secondary	Visual Analog Scale (VAS) for pain measurement	questionnaire	1 year
Secondary	Medication Consumption	Track increase or decrease in Medication consumption- assessed through patient interview and patent report	1 year
Secondary	Medication Costs	Calculate monetary savings in Medication Costs- assessed through patient interview and prevailing market cost information	1 year
Secondary	Hospitalization utilizations	Calculate the increase/decrease in hospital facility utilization - assessed with patient interview and health records.	1 year