Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02606370
Other study ID # UNIVERSITY CARDENAL HERRERA
Secondary ID
Status Completed
Phase N/A
First received November 11, 2015
Last updated September 20, 2017
Start date January 2016
Est. completion date May 2016

Study information

Verified date September 2017
Source Cardenal Herrera University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients with Chronic LBP

- BMI < 30

Exclusion Criteria:

- Hernia

- Lower limb pathologies

- Previous experience with unstable shoes

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Unstable shoe
Wearing Unstable shoes during 1 month

Locations

Country Name City State
Spain University CEU Cardenal Herrera Moncada Valencia

Sponsors (1)

Lead Sponsor Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Lisón JF, Pérez-Soriano P, Llana-Belloch S, Sánchez-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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Disability (assessed by Roland Morris Questionaire) At 1 month
Secondary EMG activity of trunk muscles At baseline and at 1 month follow-up
Secondary Lumbar spine range of movement (sagittal plane) At baseline and at 1 month follow-up
See also
  Status Clinical Trial Phase
Completed NCT03916705 - Thoraco-Lumbar Fascia Mobility N/A
Completed NCT04007302 - Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Recruiting NCT03600207 - The Effect of Diaphragm Muscle Training on Chronic Low Back Pain N/A
Completed NCT04284982 - Periodized Resistance Training for Persistent Non-specific Low Back Pain N/A
Recruiting NCT05600543 - Evaluation of the Effect of Lumbar Belt on Spinal Mobility in Subjects With and Without Low Back Pain N/A
Withdrawn NCT05410366 - Safe Harbors in Emergency Medicine, Specific Aim 3
Completed NCT03673436 - Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
Completed NCT02546466 - Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain N/A
Completed NCT00983385 - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase 3
Recruiting NCT05156242 - Corticospinal and Motor Behavior Responses After Physical Therapy Intervention in Patients With Chronic Low Back Pain. N/A
Recruiting NCT04673773 - MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain. N/A
Completed NCT06049277 - Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain N/A
Completed NCT06049251 - ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises N/A
Completed NCT04980469 - A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle N/A
Completed NCT04055545 - High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects N/A
Recruiting NCT05944354 - Wearable Spine Health System for Military Readiness
Recruiting NCT05552248 - Assessment of the Safety and Performance of a Lumbar Belt
Completed NCT05801588 - Participating in T'ai Chi to Reduce Back Pain and Improve Quality of Life N/A
Completed NCT05811143 - Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.