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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Unstable shoe
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Unstable Shoes;Trunk muscles;Lumbar lordosis;Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Chronic LBP
  • BMI < 30

Exclusion Criteria:

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

Sites / Locations

  • University CEU Cardenal Herrera

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Unstable shoes

Control Group

Arm Description

Wearing unstable shoes during 1 month

Not Wearing unstable shoes

Outcomes

Primary Outcome Measures

Disability (assessed by Roland Morris Questionaire)

Secondary Outcome Measures

EMG activity of trunk muscles
Lumbar spine range of movement (sagittal plane)

Full Information

First Posted
November 11, 2015
Last Updated
September 20, 2017
Sponsor
Cardenal Herrera University
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1. Study Identification

Unique Protocol Identification Number
NCT02606370
Brief Title
Effects of Unstable Shoes on Trunk Muscle Activity, Lumbar Spine Kinematics and Pain in Patients With Low Back Pain
Official Title
Effects of Unstable Shoes on Trunk Muscle Activity, Lumbar Spine Kinematics and Pain in Patients With Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Unstable Shoes;Trunk muscles;Lumbar lordosis;Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unstable shoes
Arm Type
Experimental
Arm Description
Wearing unstable shoes during 1 month
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Not Wearing unstable shoes
Intervention Type
Other
Intervention Name(s)
Unstable shoe
Intervention Description
Wearing Unstable shoes during 1 month
Primary Outcome Measure Information:
Title
Disability (assessed by Roland Morris Questionaire)
Time Frame
At 1 month
Secondary Outcome Measure Information:
Title
EMG activity of trunk muscles
Time Frame
At baseline and at 1 month follow-up
Title
Lumbar spine range of movement (sagittal plane)
Time Frame
At baseline and at 1 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Chronic LBP BMI < 30 Exclusion Criteria: Hernia Lower limb pathologies Previous experience with unstable shoes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JF Lisón, Dr.
Organizational Affiliation
Cardenal Herrera University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pablo Salvador-Coloma
Organizational Affiliation
Cardenal Herrera University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University CEU Cardenal Herrera
City
Moncada
State/Province
Valencia
ZIP/Postal Code
46113
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25854301
Citation
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.
Results Reference
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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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