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

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ClinicalTrials.gov Identifier: NCT02606370
Recruitment Status : Completed
First Posted : November 17, 2015
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Juan F. Lisón Párraga, Dr, 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.


Condition or disease Intervention/treatment Phase
Low Back Pain Other: Unstable shoe Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Unstable Shoes on Trunk Muscle Activity, Lumbar Spine Kinematics and Pain in Patients With Low Back Pain
Study Start Date : January 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Unstable shoes
Wearing unstable shoes during 1 month
Other: Unstable shoe
Wearing Unstable shoes during 1 month

No Intervention: Control Group
Not Wearing unstable shoes



Primary Outcome Measures :
  1. Disability (assessed by Roland Morris Questionaire) [ Time Frame: At 1 month ]

Secondary Outcome Measures :
  1. EMG activity of trunk muscles [ Time Frame: At baseline and at 1 month follow-up ]
  2. Lumbar spine range of movement (sagittal plane) [ Time Frame: At baseline and at 1 month follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Chronic LBP
  • BMI < 30

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606370


Locations
Spain
University CEU Cardenal Herrera
Moncada, Valencia, Spain, 46113
Sponsors and Collaborators
Cardenal Herrera University
Investigators
Study Director: JF Lisón, Dr. Cardenal Herrera University
Principal Investigator: Pablo Salvador-Coloma Cardenal Herrera University

Publications of Results:
Responsible Party: Juan F. Lisón Párraga, Dr, Head of Medicine, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT02606370     History of Changes
Other Study ID Numbers: UNIVERSITY CARDENAL HERRERA
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by Juan F. Lisón Párraga, Dr, Cardenal Herrera University:
Unstable Shoes;Trunk muscles;Lumbar lordosis;Low Back Pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms