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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Unstable shoe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Chronic LBP BMI < 30 Exclusion Criteria: Hernia Lower limb pathologies Previous experience with unstable shoes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unstable shoes<br>Wearing unstable shoes during 1 month | Other: Unstable shoe<br>* Wearing Unstable shoes during 1 month<br>|
| No Intervention: Control Group<br>Not Wearing unstable shoes | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability (assessed by Roland Morris Questionaire) |  | At 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unstable Shoes;Trunk muscles;Lumbar lordosis;Low Back Pain