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

NCT ID: NCT02606370

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-05-31

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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Unstable shoes

Wearing unstable shoes during 1 month

Group Type EXPERIMENTAL

Unstable shoe

Intervention Type OTHER

Wearing Unstable shoes during 1 month

Control Group

Not Wearing unstable shoes

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Unstable shoe

Wearing Unstable shoes during 1 month

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardenal Herrera University

OTHER

Sponsor Role lead

Responsible Party

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Juan F. Lisón Párraga, Dr

Head of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JF Lisón, Dr.

Role: STUDY_DIRECTOR

Cardenal Herrera University

Pablo Salvador-Coloma

Role: PRINCIPAL_INVESTIGATOR

Cardenal Herrera University

Locations

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University CEU Cardenal Herrera

Moncada, Valencia, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT
PMID: 25854301 (View on PubMed)

Other Identifiers

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UNIVERSITY CARDENAL HERRERA

Identifier Type: -

Identifier Source: org_study_id