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Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain

NCT01865539 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2022-05-16

Study results available
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Summary

A randomized sham controlled trial evaluating the efficacy of the use of custom foot orthotics in veterans suffering from chronic lower back pain. The current study hypothesizes that those veterans with chronic lower back pain who receive the custom foot orthotics will show greater improvements in pain and disability associated with the chronic lower back pain than those who receive the sham orthotic.

Conditions

  • Back Pain Lower Back Chronic

Interventions

DEVICE

Custom Foot Orthotic

Custom foot orthotic with custom design pads

DEVICE

Sham Orthotic

Leather insert without the custom design pads

Sponsors & Collaborators

  • Foot Levelers, Inc.

    collaborator INDUSTRY

  • Northeast College of Health Sciences

    collaborator OTHER

  • Canandaigua VA Medical Center

    lead FED

Principal Investigators

  • Paul E Dougherty, DC · Canandaigua VA Medical Center/ New York Chiropractic College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-01-31
Completion
2016-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01865539 on ClinicalTrials.gov