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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Unstable shoe

• Registration Number: NCT02606370
• Lead Sponsor: Cardenal Herrera University

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-11-14
• Study First Posted: 2015-11-17
• Study Start: 2016-01
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-20
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with Chronic LBP
• BMI < 30

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unstable shoes	Unstable shoe	Wearing unstable shoes during 1 month

Primary Outcome Measures

Name	Time	Method
Disability (assessed by Roland Morris Questionaire)	At 1 month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University CEU Cardenal Herrera; 🇪🇸 Moncada, Valencia, Spain