Even-Up to Minimize Secondary Site Pain For Ankle Fracture

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    100
  • sponsor
    Brigham and Women's Hospital
Updated on 26 July 2021

Summary

Evaluating impact of use of Even-Up shoe wear device for patients treated in CAM boot walker for an ankle fracture. Randomized controlled trial, randomizing patients into control group with boot treatment only versus boot treatment with Even-Up device on contralateral extremity.

Description

A variety of foot and ankle injuries can be treated effectively through the use of a controlled ankle movement (CAM) walker boot. CAM walker boots protect the injured area by restricting foot and ankle motion, providing a stable platform to distribute forces while bearing weight, and allowing the user to rollover the foot during ambulation because of a rocker bottom-shaped sole. Such qualities lend the CAM walker boot to provide ankle support that can be advantageous compared with other commonly used methods. Despite their utility, CAM walker boots create a simulated leg-length discrepancy (LLD), which can result in altered biomechanics during ambulation. Additionally, a LLD can be associated with lower back and joint pain.

We have previously conducted a study that suggests a relationship exists between CAM walker boot treatment and pain at sites other than the extremity being treated. There have been several randomized controlled trials (RCTs) examining a relationship between the correction of inherent LLD with insole inserts and lower back pain. Furthermore, there has been a past RCT and there is a current RCT examining a relationship between the use of the EVENup orthotic shoe lift to correct CAM walker boot simulated LLD and pain at sites other than the extremity being treated. However, these studies were not conducted with patient populations with uniform injuries. To the best of our knowledge, an RCT has not been conducted with the EVENup orthotic shoe lift to examine this relationship in a uniform patient population with nonoperative ankle fractures. This RCT aims to assess the efficacy of the EVENup orthotic shoe lift, towards reducing and even preventing such pain that may be associated with this common course of treatment.

Details
Condition Arthralgia, Pain, Chronic Leg Pain, Post-Surgical Pain, Pain (Pediatric), Trouble Balancing, joint pain, pain, joint, arthralgias
Treatment Even-Up
Clinical Study IdentifierNCT04164563
SponsorBrigham and Women's Hospital
Last Modified on26 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Non-operative Treatment of Ankle Fracture
CAM boot as treatment for injury
Weight bearing ad lib

Exclusion Criteria

Pregnancy
Non-English speaking
Recent surgery for lower extremity or back
Recent other injury to lower extremity or back
Restricted weight bearing
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