Laterality Discrimination in Patients With Non-specific Chronic Neck Pain

March 1, 2019 updated by: Jose Vicente Leon Hernandez, Centro Universitario La Salle

Effects of Laterality Discrimination in Patients With Non-specific Chronic Neck Pain. Randomized Blind Clinical Trial

Chronic neck pain is one of the most common causes of pain, affecting 15% of the adult population, and the fourth leading cause of disability. The recognition of laterality is the ability to recognize a part of the body that belongs to the left or right which is used as a tool to create a normal process of motor planning.

Study Overview

Status

Completed

Conditions

Detailed Description

The most consistent data come from the investigation of the primary motor cortex, in which the cortical representations of the altered body part are affected when there is chronic pain. Occasionally, the primary motor cortex is smaller on the affected side than on the contralateral side.

Recognition of the body schema is altered in the presence of painful disorders. The most common way of assessing the body schema is by motor imagery through the laterality discrimination of the left and right.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The inclusion criteria were as follows: a) men and women aged between 18- and 65-years b) medical diagnosis of Non-Specific Chronic Neck Pain with more than 6 months of evolution of neck pain.

Exclusion Criteria:

  • Exclusion criteria included the following: a) patients with rheumatic diseases, cervical hernia, cervical whiplash syndrome, neck surgeries or history of arthrodesis, b) systemic diseases, c) vision, hearing or vestibular problems, d) Severe trauma or traffic accident which has had an impact on the cervical area.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neck Laterality
It was done with 20 images of necks and 4 seconds for each image in the Vanilla program of the tablet application.
Patients who belonged to the neck group performed the recognition of laterality with certain parameters. The execution of the recognition began with a test to familiarize themselves with the program at the "Basic" level and then followed the laterality test. It was done with 20 images and 4 seconds for each image in the "Vanilla" program
Experimental: Foot Laterality
It was done with 20 images of feet and 4 seconds for each image in the Vanilla program of the tablet application.
Patients who belonged to the foot group performed the recognition of laterality with certain parameters. The execution of the recognition began with a test to familiarize themselves with the program at the "Basic" level and then followed the laterality test. It was done with 20 images and 4 seconds for each image in the "Vanilla" program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response time
Time Frame: Immediately post-intervention
Changes in the time response. Time response is defined as the time between the image appearance and the subject response.
Immediately post-intervention
Accuracy
Time Frame: Immediately post-intervention
Changes in the accuracy at the end of the intervention. Accuracy must be taken as the precision of the response when a subject say wether the image is right or left. It is measured by percentage of success.
Immediately post-intervention
Joint Position Error
Time Frame: Immediately post-intervention
Changes in the joint position error at the end of the intervention. It is measured on centimeters.
Immediately post-intervention
Cervical Active Range of Motion
Time Frame: immediately post-intervention
Changes the cervical active range of motion at the end of the intervention. It is measured on centimeters.
immediately post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: David Marcos Lorenzo, Msc, d.marcosl20@gmail.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

February 26, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

March 4, 2019

Last Update Submitted That Met QC Criteria

March 1, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSEULS-PI-155/2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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