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Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01865539
Recruitment Status : Terminated (Difficulty with recruitment/funding)
First Posted : May 31, 2013
Last Update Posted : June 16, 2016
Foot Levelers, Inc.
New York Chiropractic College
Information provided by (Responsible Party):
Paul Dougherty, DC, Canandaigua VA Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Back Pain Lower Back Chronic Device: Custom Foot Orthotic Device: Sham Orthotic Phase 2 Phase 3

Detailed Description:

Specific Aim 1: Utilizing a gold standard sham controlled randomized trial design, we will evaluate the change in pain, back related disability and quality of life in Veterans with CLBP who utilize either a custom foot orthotic or a sham orthotic.

As part of this aim the investigators will build on the teams strength of recruiting and enrolling Veteran's with CLBP into a randomized trial. The investigators will collect baseline pain and disability measures utilizing validated tools. Once the patients are enrolled, utilizing the "gold standard" placebo controlled design the investigators will randomize patients to receive either a custom foot orthotic or a sham orthotic. The Veterans will then be assessed at 5, 12 and 24-weeks post baseline to evaluate differences in pain and disability. Based on previous studies on the effectiveness of custom foot orthotics the investigators hypothesize that that Veteran's who receive the custom orthotic will experience less pain and disability as compared to those who receive the sham orthotics.

Specific Aim 2: To evaluate baseline characteristics of Veterans with CLBP predictive of responsiveness to custom foot orthotics including age, BMI, psychosocial characteristics and arch classification.

Focusing on the Veterans who receive the custom foot orthotic, the investigators next examine the important characteristics that may predict those Veterans who are most likely to benefit from wearing custom foot orthotics. Assessing potential confounders or facilitators of effectiveness of the custom foot orthotic will allow the investigators to best describe potential mechanisms of responsiveness. The investigators have chosen previously described confounders to responsiveness to treatment of CLBP, specifically age, body mass index and psychosocial characteristics. This methodology is particularly important in a sham controlled trial to assess if effectiveness or lack of thereof, is a factor of the intervention or from other confounding variables. The investigators have also chosen to evaluate the arch classification based on the measurement of the Veterans arch; again this allows for specific recommendations concerning use of this product. Based on previous studies on the effectiveness of custom foot orthotics in addition to previous studies evaluating CLBP the investigators hypothesize that those Veterans who are older, have a higher BMI and greater fear avoidance belief scores will show less responsiveness to the custom foot orthotics as compared to those younger Veterans who have a lower BMI and lower fear avoidance belief scores. In addition based on previous biomechanical literature, the investigators feel that those Veterans with a lower arch will show the greatest responsiveness to the custom foot orthotic.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain
Study Start Date : May 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Custom Foot Orthotic
Custom foot orthotic
Device: Custom Foot Orthotic
Custom foot orthotic with custom design pads
Other Name: Foot Levelers Custom Foot Orthotic

Sham Comparator: Sham Orthotic
Will be a sham orthotic that will be the same as the actual orthotic without the custom support pads.
Device: Sham Orthotic
Leather insert without the custom design pads

Primary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: Change from Baseline at 5, 12 and 24 weeks. ]
    Visual Analog Scales (VAS): The VAS has become very popular in pain research and in the clinical assessment of pain. The test has shown test-retest reliability, intra-examiner reliability and inter-examiner reliability.

Secondary Outcome Measures :
  1. Modified Oswestry Disability Index (mODI) [ Time Frame: Change from Baseline at 5, 12 and 24 weeks. ]
    The back pain specific, self-rating scale evaluates the degree of functional impairment that a patient is experiencing in a number of activities of daily living. John O'Brien first developed it in 1976. Since that time, the original authors have created a revision, the ODI 2.0. The ODI has been found to have high reliability for test-retest and also for internal consistency. The ODI has been shown to reliably predict functional disability as tested by functional capacity evaluation and physical performance tests. There is no direct cost involved in the administration of this test and there are no adverse effects associated with the administration of this test.

  2. Patient Reported Outcome Measurement Information System (PROMIS) Physical Function [ Time Frame: Change from Baseline at 5, 12 and 24 weeks. ]
    As part of the National Institutes of Health Roadmap PROMIS was developed to address several shortcomings of the historically used patient reported outcome questionnaires. PROMIS attempts to acquire precise meaningful data in a short number of questions by the application of item response theory, and CAT 31. This has resulted in an electronic questionnaire of between 6 and 12 questions. PROMIS has varied instruments designed to look at a variety of chronic conditions, for the purposes of this study we will be utilizing the Physical Function instrument, which has been previously utilized in a variety of orthopedic patient populations

Other Outcome Measures:
  1. RAND 36-Item Health Survey [ Time Frame: Change from Baseline at 5, 12 and 24 weeks. ]
    The medical outcomes survey SF-36 was first developed for use in the longitudinal component of a medical outcomes study, a four-year observational study of health outcomes among patients with chronic medical and psychiatric conditions. The RAND 36-Item Health Survey consists of 36 items covering eight generic health concepts: physical functioning, role disability due to physical problems, bodily pain, general health perceptions vitality, social functioning, role disability due to emotional health problems and general mental health. Specific to this study the statistical analysis is based on bodily pain and physical functioning. These two measures have been previously utilized in other research on spinal pain syndromes and found to be reliable and valid.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Ages 18-65 Lower back pain ≥ 3 months in duration Pain elicited upon deep palpation of the lumbar erector spinae musculature Primary complaint of CLBP from L1 to Sacroiliac joint inclusive. Ability/willingness to use orthotics in their shoes Numeric Pain Rating Scale (NRPS) of ≥ 3

  • 30 mm on the Visual Analogue Scale (VAS)
  • 20% for the Modified Oswestry Disability Index (mODI)


spinal surgery, spinal injections or injections in their feet within the past 6 months Inability to use orthotics in shoes Custom foot orthotics within the past 12 months Currently undergoing Chiropractic, Physical Therapy or Acupuncture treatment for their chronic lower back pain.

evidence of cauda equina syndrome, spinal neoplasia or metastatic disease, destructive joint pathology such as rheumatoid arthritis bowel/bladder dysfunction (associated with the back pain) peripheral neuropathy or progressive lumbosacral radiculopathy, progressive myelopathy or neurogenic claudication.

open workers compensation or no fault case.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01865539

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United States, New York
Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center
Rochester, New York, United States, 14620
Sponsors and Collaborators
Canandaigua VA Medical Center
Foot Levelers, Inc.
New York Chiropractic College
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Principal Investigator: Paul E Dougherty, DC Canandaigua VA Medical Center/ New York Chiropractic College

Additional Information:
Publications of Results:
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Responsible Party: Paul Dougherty, DC, Chiropractor, Canandaigua VA Medical Center Identifier: NCT01865539     History of Changes
Other Study ID Numbers: MIRB00558
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Paul Dougherty, DC, Canandaigua VA Medical Center:
Chronic lower back pain
Custom foot orthotics
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms