Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain

Not Applicable

Terminated

Conditions: Back Pain Lower Back Chronic

Interventions: Device: Custom Foot Orthotic
Device: Sham Orthotic

Registration Number: NCT01865539

Lead Sponsor: 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.

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 chronic lower back pain 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 chronic lower back pain 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 chronic lower back pain 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 chronic lower back pain, 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 chronic lower back pain 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Custom Foot Orthotic	Custom Foot Orthotic	Custom foot orthotic
Sham Orthotic	Sham Orthotic	Will be a sham orthotic that will be the same as the actual orthotic without the custom support pads.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	24 weeks.	Visual Analog Scales (VAS): VAS is rated from 0 to 100mm with 0 being no pain at all and 100mm being the worst pain imaginable. The test has shown test-retest reliability, intra-examiner reliability and inter-examiner reliability.

Secondary Outcome Measures

Name	Time	Method
Modified Oswestry Disability Index (mODI)	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. Oswestry is scored on a scale of 0-50 with 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled
Patient Reported Outcome Measurement Information System (PROMIS) Physical Function	24 weeks.	For PROMIS measures, higher scores equals more of the concept being measured (more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. Specifically for PROMIS Physical function 50 indicates the reference population, therefore a score of 40 would be lower physical function.