NCT02606370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

3 months

First QC Date

November 11, 2015

Last Update Submit

September 20, 2017

Conditions

Low Back Pain

Keywords

Unstable Shoes;Trunk muscles;Lumbar lordosis;Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Disability (assessed by Roland Morris Questionaire)

    At 1 month

Secondary Outcomes (2)

  • 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

Study Arms (2)

Unstable shoes

EXPERIMENTAL

Wearing unstable shoes during 1 month

Other: Unstable shoe

Control Group

NO INTERVENTION

Not Wearing unstable shoes

Interventions

Unstable shoeOTHER

Wearing Unstable shoes during 1 month

Unstable shoes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Chronic LBP
  • BMI \< 30

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University CEU Cardenal Herrera

Moncada, Valencia, 46113, Spain

Location

Related Publications (1)

  • 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.

    PMID: 25854301RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • JF Lisón, Dr.

    Cardenal Herrera University

    STUDY DIRECTOR

  • Pablo Salvador-Coloma

    Cardenal Herrera University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Medicine

Study Record Dates

First Submitted

November 11, 2015

First Posted

November 17, 2015

Study Start

January 1, 2016

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

September 25, 2017

Record last verified: 2017-09

Locations

ES(1)