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Pain Neuroscience Education and Exercise

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Pain neuroscience education
Sponsored by
Aveiro University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

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

Inclusion Criteria:

  • Participants could enter the study if they had chronic idiopathic neck pain, defined as pain felt in the neck at least once a week in the previous 3 months and for which no cause had been established. Furthermore, they were required to have a minimum pain intensity in the previous week of 2 in the visual analogue scale.

Exclusion Criteria:

  • Participants were excluded if they had had physiotherapy for their neck pain in the 6 months previous to the study, if they had rheumatic, nervous, cardiac and/or respiratory pathology that could prevent or make it difficult to do the exercises. Exclusion criteria were ascertained by self-report.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    pain neuroscience education and exercise

    Exercise

    Arm Description

    This group received pain neuroscience education and exercise once a week over 4 weeks

    This group received exercise directed at the neck and shoulder regions once a week over 4 weeks

    Outcomes

    Primary Outcome Measures

    Pain intensity
    Measured using the visual analogue scale
    Pain intensity
    Measured using the visual analogue scale
    Pain intensity
    Measured using the visual analogue scale

    Secondary Outcome Measures

    Deep neck flexor endurance
    Method of assessment - physical test; the participant is in supine and he/she is asked to flex the upper cervical spine, move their head away from the couch approximately 2.5 cm and then maintain this position for as long as possible. The test result is the time (in seconds) that each participant holds the position.
    Deep neck flexor endurance
    Method of assessment - physical test; the participant is in supine and he/she is asked to flex the upper cervical spine, move their head away from the couch approximately 2.5 cm and then maintain this position for as long as possible. The test result is the time (in seconds) that each participant holds the position.
    Neck extensors endurance
    Method of assessment - physical test; the participant is in prone and position, head neutral, and supporting 2 Kg weight hanging from it. Participants were asked to support this weight for as long as possible while maintaining the neutral head positioning. The test result is the time (in seconds) that each participant holds the position.
    Neck extensors endurance
    Method of assessment - physical test; the participant is in prone and position, head neutral, and supporting 2 Kg weight hanging from it. Participants were asked to support this weight for as long as possible while maintaining the neutral head positioning. The test result is the time (in seconds) that each participant holds the position.
    Scapular stabilizers endurance
    Method of assessment - physical test; Method of assessment - physical test; Participants were standing with the shoulders and elbows flexed at 90º, while pulling both extremities of a dynamometer to reach 1 Kg of force. The test result is the time (in seconds) that each participants was able to hold this position.
    Scapular stabilizers endurance
    Method of assessment - physical test; Method of assessment - physical test; Participants were standing with the shoulders and elbows flexed at 90º, while pulling both extremities of a dynamometer to reach 1 Kg of force. The test result is the time (in seconds) that each participants was able to hold this position.
    Pressure pain thresholds
    Method of assessment - psychophysical test; Pressure was applied over the trapezius and at C5-C6 with a algometer until the participant first felt pain. The results was the quantity of force (in Kgf) supported by participants.
    Pressure pain thresholds
    Method of assessment - psychophysical test; Pressure was applied over the trapezius and at C5-C6 with a algometer until the participant first felt pain. The results was the quantity of force (in Kgf) supported by participants.
    Disability
    Method of assessment - the neck pain disability index
    Disability
    Method of assessment - the neck pain disability index
    Disability
    Method of assessment - the neck pain disability index
    catastrophizing
    Method of assessment - Pain catastrophising scale
    catastrophizing
    Method of assessment - Pain catastrophising scale
    catastrophizing
    Method of assessment - Pain catastrophising scale
    fear of movement
    method of assessment - the Tampa Scale
    fear of movement
    method of assessment - the Tampa Scale
    fear of movement
    method of assessment - the Tampa Scale
    Knowledge of pain neurophysiology
    method of assessment - scale; the neurophysiology of pain questionnaire
    Knowledge of pain neurophysiology
    method of assessment - scale; the neurophysiology of pain questionnaire
    Knowledge of pain neurophysiology
    method of assessment - scale; the neurophysiology of pain questionnaire

    Full Information

    First Posted
    November 28, 2017
    Last Updated
    December 4, 2017
    Sponsor
    Aveiro University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03362333
    Brief Title
    Pain Neuroscience Education and Exercise
    Official Title
    Pain Neuroscience Education and Exercise Versus Exercise for University Students With Chronic Idiopathic Neck Pain: a Randomized, Controlled and Single Blind Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2015 (Actual)
    Primary Completion Date
    February 28, 2016 (Actual)
    Study Completion Date
    October 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aveiro University

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain.
    Detailed Description
    This study examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain. University students with chronic neck pain were randomly allocated to receive pain neuroscience education and exercise or exercise only and assessed at baseline, after the intervention and at 3 months follow up. Outcome variables were pain intensity (primary outcome), disability, fear of movement, catastrophizing, knowledge of pain neurophysiology, pressure pain thresholds and neck and scapular muscle endurance.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neck Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    pain neuroscience education and exercise
    Arm Type
    Experimental
    Arm Description
    This group received pain neuroscience education and exercise once a week over 4 weeks
    Arm Title
    Exercise
    Arm Type
    Active Comparator
    Arm Description
    This group received exercise directed at the neck and shoulder regions once a week over 4 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Intervention Description
    Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular stabilizer muscles.
    Intervention Type
    Other
    Intervention Name(s)
    Pain neuroscience education
    Intervention Description
    Pain neuroscience education covered the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience.
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    Measured using the visual analogue scale
    Time Frame
    At the beginning
    Title
    Pain intensity
    Description
    Measured using the visual analogue scale
    Time Frame
    5 weeks
    Title
    Pain intensity
    Description
    Measured using the visual analogue scale
    Time Frame
    At 3 months
    Secondary Outcome Measure Information:
    Title
    Deep neck flexor endurance
    Description
    Method of assessment - physical test; the participant is in supine and he/she is asked to flex the upper cervical spine, move their head away from the couch approximately 2.5 cm and then maintain this position for as long as possible. The test result is the time (in seconds) that each participant holds the position.
    Time Frame
    At the beginning
    Title
    Deep neck flexor endurance
    Description
    Method of assessment - physical test; the participant is in supine and he/she is asked to flex the upper cervical spine, move their head away from the couch approximately 2.5 cm and then maintain this position for as long as possible. The test result is the time (in seconds) that each participant holds the position.
    Time Frame
    5 weeks
    Title
    Neck extensors endurance
    Description
    Method of assessment - physical test; the participant is in prone and position, head neutral, and supporting 2 Kg weight hanging from it. Participants were asked to support this weight for as long as possible while maintaining the neutral head positioning. The test result is the time (in seconds) that each participant holds the position.
    Time Frame
    At the beginning
    Title
    Neck extensors endurance
    Description
    Method of assessment - physical test; the participant is in prone and position, head neutral, and supporting 2 Kg weight hanging from it. Participants were asked to support this weight for as long as possible while maintaining the neutral head positioning. The test result is the time (in seconds) that each participant holds the position.
    Time Frame
    5 weeks
    Title
    Scapular stabilizers endurance
    Description
    Method of assessment - physical test; Method of assessment - physical test; Participants were standing with the shoulders and elbows flexed at 90º, while pulling both extremities of a dynamometer to reach 1 Kg of force. The test result is the time (in seconds) that each participants was able to hold this position.
    Time Frame
    At the beginning
    Title
    Scapular stabilizers endurance
    Description
    Method of assessment - physical test; Method of assessment - physical test; Participants were standing with the shoulders and elbows flexed at 90º, while pulling both extremities of a dynamometer to reach 1 Kg of force. The test result is the time (in seconds) that each participants was able to hold this position.
    Time Frame
    5 weeks
    Title
    Pressure pain thresholds
    Description
    Method of assessment - psychophysical test; Pressure was applied over the trapezius and at C5-C6 with a algometer until the participant first felt pain. The results was the quantity of force (in Kgf) supported by participants.
    Time Frame
    At the beginning
    Title
    Pressure pain thresholds
    Description
    Method of assessment - psychophysical test; Pressure was applied over the trapezius and at C5-C6 with a algometer until the participant first felt pain. The results was the quantity of force (in Kgf) supported by participants.
    Time Frame
    5 weeks
    Title
    Disability
    Description
    Method of assessment - the neck pain disability index
    Time Frame
    At the beginning
    Title
    Disability
    Description
    Method of assessment - the neck pain disability index
    Time Frame
    5 weeks
    Title
    Disability
    Description
    Method of assessment - the neck pain disability index
    Time Frame
    3 months
    Title
    catastrophizing
    Description
    Method of assessment - Pain catastrophising scale
    Time Frame
    at beginning
    Title
    catastrophizing
    Description
    Method of assessment - Pain catastrophising scale
    Time Frame
    5 weeks
    Title
    catastrophizing
    Description
    Method of assessment - Pain catastrophising scale
    Time Frame
    3 months
    Title
    fear of movement
    Description
    method of assessment - the Tampa Scale
    Time Frame
    At the beginning
    Title
    fear of movement
    Description
    method of assessment - the Tampa Scale
    Time Frame
    5 weeks
    Title
    fear of movement
    Description
    method of assessment - the Tampa Scale
    Time Frame
    3 months
    Title
    Knowledge of pain neurophysiology
    Description
    method of assessment - scale; the neurophysiology of pain questionnaire
    Time Frame
    at beginning
    Title
    Knowledge of pain neurophysiology
    Description
    method of assessment - scale; the neurophysiology of pain questionnaire
    Time Frame
    5 weeks
    Title
    Knowledge of pain neurophysiology
    Description
    method of assessment - scale; the neurophysiology of pain questionnaire
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants could enter the study if they had chronic idiopathic neck pain, defined as pain felt in the neck at least once a week in the previous 3 months and for which no cause had been established. Furthermore, they were required to have a minimum pain intensity in the previous week of 2 in the visual analogue scale. Exclusion Criteria: Participants were excluded if they had had physiotherapy for their neck pain in the 6 months previous to the study, if they had rheumatic, nervous, cardiac and/or respiratory pathology that could prevent or make it difficult to do the exercises. Exclusion criteria were ascertained by self-report.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anabela Silva, PhD
    Organizational Affiliation
    University of Aveiro
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Pain Neuroscience Education and Exercise

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