Effects of Unstable Shoes on Trunk Muscle Activity, Lumbar Spine Kinematics and Pain in Patients With Low Back Pain

Overview

Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait using an unstable shoe (Intervention group) and a conventional stable control shoe (Control Group). Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients with Low Back Pain.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: April 2016

Detailed Description

Background: An unstable shoe was developed as a walking device to strengthen the lower extremity muscles and reduce joint loading. A large number of studies have reported increased electromyographic (EMG) activity throughout the gait cycle in most of the lower limb muscles, and significant kinematic changes in the lower extremity. However, no studies have investigated the effects of wearing (1 month) unstable shoes on 1) spine kinematics, 2) trunk muscle activity and 3) Low Back Pain (LBP) during gait in Patients with chronic LBP. Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait using an unstable shoe (Intervention group) and a conventional stable control shoe (Control Group). Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients with Low Back Pain.

Interventions

  • Other: Unstable shoe
    • Wearing Unstable shoes during 1 month

Arms, Groups and Cohorts

  • Experimental: Unstable shoes
    • Wearing unstable shoes during 1 month
  • No Intervention: Control Group
    • Not Wearing unstable shoes

Clinical Trial Outcome Measures

Primary Measures

  • Disability (assessed by Roland Morris Questionaire)
    • Time Frame: At 1 month

Secondary Measures

  • EMG activity of trunk muscles
    • Time Frame: At baseline and at 1 month follow-up
  • Lumbar spine range of movement (sagittal plane)
    • Time Frame: At baseline and at 1 month follow-up

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with Chronic LBP – BMI < 30 Exclusion Criteria:

  • Hernia – Lower limb pathologies – Previous experience with unstable shoes

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cardenal Herrera University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Juan F. Lisón Párraga, Dr, Head of Medicine – Cardenal Herrera University
  • Overall Official(s)
    • JF Lisón, Dr., Study Director, Cardenal Herrera University
    • Pablo Salvador-Coloma, Principal Investigator, Cardenal Herrera University

Citations Reporting on Results

Lison JF, Perez-Soriano P, Llana-Belloch S, Sanchez-Zuriaga D, Salvador-Coloma P. Effects of unstable shoes on trunk muscle activity and lumbar spine kinematics. Eur J Phys Rehabil Med. 2016 Aug;52(4):440-6. Epub 2015 Apr 9.

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