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Laterality Discrimination in Patients With Non-specific Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neck Laterality
Foot Laterality
Sponsored by
Centro Universitario La Salle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Laterality task, neck pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Neck Laterality

    Foot Laterality

    Arm Description

    It was done with 20 images of necks and 4 seconds for each image in the Vanilla program of the tablet application.

    It was done with 20 images of feet and 4 seconds for each image in the Vanilla program of the tablet application.

    Outcomes

    Primary Outcome Measures

    Response time
    Changes in the time response. Time response is defined as the time between the image appearance and the subject response.
    Accuracy
    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.
    Joint Position Error
    Changes in the joint position error at the end of the intervention. It is measured on centimeters.
    Cervical Active Range of Motion
    Changes the cervical active range of motion at the end of the intervention. It is measured on centimeters.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 26, 2019
    Last Updated
    March 1, 2019
    Sponsor
    Centro Universitario La Salle
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03861312
    Brief Title
    Laterality Discrimination in Patients With Non-specific Chronic Neck Pain
    Official Title
    Effects of Laterality Discrimination in Patients With Non-specific Chronic Neck Pain. Randomized Blind Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2016 (Actual)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    September 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centro Universitario La Salle

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neck Pain
    Keywords
    Laterality task, neck pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Neck Laterality
    Arm Type
    Experimental
    Arm Description
    It was done with 20 images of necks and 4 seconds for each image in the Vanilla program of the tablet application.
    Arm Title
    Foot Laterality
    Arm Type
    Experimental
    Arm Description
    It was done with 20 images of feet and 4 seconds for each image in the Vanilla program of the tablet application.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Neck Laterality
    Intervention Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Foot Laterality
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Response time
    Description
    Changes in the time response. Time response is defined as the time between the image appearance and the subject response.
    Time Frame
    Immediately post-intervention
    Title
    Accuracy
    Description
    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.
    Time Frame
    Immediately post-intervention
    Title
    Joint Position Error
    Description
    Changes in the joint position error at the end of the intervention. It is measured on centimeters.
    Time Frame
    Immediately post-intervention
    Title
    Cervical Active Range of Motion
    Description
    Changes the cervical active range of motion at the end of the intervention. It is measured on centimeters.
    Time Frame
    immediately post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Marcos Lorenzo, Msc
    Organizational Affiliation
    d.marcosl20@gmail.com
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Laterality Discrimination in Patients With Non-specific Chronic Neck Pain

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