Effects of Unstable Shoes on Trunk Muscle Activity, Lumba... | NCT02606370

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

NCT02606370

Sponsor

Cardenal Herrera University

Status

Completed

Last Update Posted

Sep 25, 2017Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Low Back Pain

Interventions

Unstable shoe

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Apr 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Nov 11, 2015

First Submission Date that Met QC Criteria

Nov 14, 2015

First Posted Date

Nov 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2017

Last Update Posted Date

Sep 25, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Juan F. Lisón Párraga, Dr, Head of Medicine, Cardenal Herrera UniversityPrincipal Investigator

Lead Sponsor

Cardenal Herrera UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Unstable shoes	Experimental	Wearing unstable shoes during 1 month	Other: Unstable shoe
Control Group	No Intervention	Not Wearing unstable shoes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Unstable shoe	Other	Wearing Unstable shoes during 1 month	Unstable shoes

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Chronic LBP
BMI < 30

Exclusion Criteria:

Hernia
Lower limb pathologies
Previous experience with unstable shoes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
JF Lisón, Dr.	Cardenal Herrera University	Study Director
Pablo Salvador-Coloma	Cardenal Herrera University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University CEU Cardenal Herrera		Moncada	Valencia	46113	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25854301	Result	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.

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms