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AposTherapy for Back Pain (AposBack Trial)
N/A
Waitlist Available
Led By Matthew N Bartels, MD, MPH
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial tests AposTherapy®, a home-based exercise program using special shoes, to help people with nonspecific low back pain. The shoes change how people move, reducing pain and improving function. It targets urban inner-city patients who may not respond well to traditional treatments.
Who is the study for?
This trial is for adults aged 30-85 with chronic lower back pain lasting at least 24 weeks, a BMI between 17 and 40, who can walk and are on a stable pain medication regimen. It's not for those with recent lumbar procedures, major heart or lung conditions, changes in certain medications, neuromuscular diseases, frequent falls due to balance issues, or ongoing cancer treatments.
What is being tested?
The study compares AposTherapy—a home exercise program using special footwear designed to improve walking mechanics—with traditional physical therapy. The goal is to see if AposTherapy can better relieve back pain and enhance function in an urban population.
What are the potential side effects?
While the trial description does not specify side effects of AposTherapy or traditional physical therapy directly, potential side effects may include muscle soreness or strain from new exercises.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Function
Secondary study objectives
6-min walk test
Blood pressure
Dynamic balance
+12 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AposTherapyExperimental Treatment1 Intervention
Treatment with at home AposTherapy with daily use of the shoe.
Group II: Traditional Physical TherapyActive Control1 Intervention
Up to 20 sessions of traditional physical therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AposTherapy
2017
N/A
~170
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Who is running the clinical trial?
Apos Medical and Sports Technology Ltd.Industry Sponsor
6 Previous Clinical Trials
539 Total Patients Enrolled
Montefiore Medical CenterLead Sponsor
456 Previous Clinical Trials
588,356 Total Patients Enrolled
Matthew N Bartels, MD, MPHPrincipal InvestigatorMontefiore Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not currently being treated for any type of cancer.Your body mass index (BMI) is between 17 and 40.You can walk at least 50 meters and pass the STEADI test.You have pain score of 3cm or more at the start of the study.People aged 30 to 85, regardless of gender.You can walk every day and take part in a rehabilitation program.You have not had a lumbar intervention using imaging guidance in the last 8 weeks.You don't have serious heart problems and can join an exercise program.You have started taking medication to lower your cholesterol in the last 12 weeks.You have not had physical therapy for your back in the last 12 weeks.You have pain that is caused by a nerve in your spine.You have pain all over your body, including your arms and legs.You have been diagnosed with a neuromuscular disease.You have had more than 3 falls in the past year, or you have had a fall where you were hurt because of balance issues.You have had a bone fracture due to weak and brittle bones.You currently have a condition with inflammation in your joints.You haven't had a heart-related issue or a COPD flare-up within the past 24 weeks.You have a walking pattern affected by a neurological condition.You need help walking during the analysis.You have had ongoing lower back pain for at least 24 weeks.
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