search
Back to results

Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
neurophysiology of pain education and exercises
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

16 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • To be invited to enter the study participants had to have chronic idiopathic neck/shoulder pain, defined as pain felt in the neck/shoulder regions at least once a week in the previous 3 months.

Exclusion Criteria:

  • No exclusion criteria

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Education and exercise

    No intervention

    Arm Description

    The intervention included neurophysiology of pain education and exercises.

    This group received no intervention as participants were students that were not seeking treatment for their pain.

    Outcomes

    Primary Outcome Measures

    Pain intensity
    Method of assessment - Visual analogue scale
    Pain intensity
    Method of assessment - Visual analogue scale

    Secondary Outcome Measures

    Neck pain frequency
    Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
    Neck pain frequency
    Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
    Neck pain duration
    Method of assessment - a question on neck pain duration (how long have you have neck pain?)
    Neck pain duration
    Method of assessment - a question on neck pain duration (how long have you have neck pain?)
    Neck pain associated disability
    Method of assessment - a disability index with 5 questions on neck pain associated disability
    Neck pain associated disability
    Method of assessment - a disability index with 5 questions on neck pain associated disability
    Neck flexor muscles endurance test
    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 flexor muscles endurance test
    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 extensor muscles endurance test
    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 extensor muscles endurance test
    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 test
    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 test
    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.
    State-trait anxiety inventory
    Method of assessment - scale
    State-trait anxiety inventory
    Method of assessment - scale
    Pain Catastrophizing Scale
    Method of assessment - scale
    Pain Catastrophizing Scale
    Method of assessment - scale
    Neurophysiology of pain questionnaire
    Method of assessment - questionnaire
    Neurophysiology of pain questionnaire
    Method of assessment - questionnaire
    Patients' Global Impression of Change
    Method of assessment - scale

    Full Information

    First Posted
    June 23, 2016
    Last Updated
    July 6, 2016
    Sponsor
    Aveiro University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02827994
    Brief Title
    Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain
    Official Title
    Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain: a School-based Pilot, Randomised and Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study compared the effectiveness of pain neurophysiology education and neck/shoulder exercises with no intervention in adolescents with chronic idiopathic neck pain (CINP).
    Detailed Description
    Forty three adolescents with chronic idiopathic neck pain were randomly allocated to receive pain neurophysiology education and shoulder/neck exercises (n=21) or no intervention (n=22). Data on pain intensity (Visual Analogue Scale), pain disability, neck flexor and extensor muscles endurance, scapulae stabilizers endurance, pain catastrophizing (Pain catastrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and knowledge of pain neurophysiology (Neurophysiology of Pain Questionnaire) were collected. Measurements were taken before and after the intervention. Statistical analysis were performed using a mixed-methods ANOVA.

    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
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Education and exercise
    Arm Type
    Experimental
    Arm Description
    The intervention included neurophysiology of pain education and exercises.
    Arm Title
    No intervention
    Arm Type
    No Intervention
    Arm Description
    This group received no intervention as participants were students that were not seeking treatment for their pain.
    Intervention Type
    Other
    Intervention Name(s)
    neurophysiology of pain education and exercises
    Intervention Description
    Pain neurophysiology education covered the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. It was delivered in small groups (4 to 7 participants). A total of 4 sessions were delivered over 4 weeks (1 session per week). Each session took between 45 minutes and 1 hour. Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular muscles delivered over 3 sessions (the first session covered pain neurophysiology education only). Each exercise was performed in 3 series of 10 repetitions. The number of exercises targeting the same group of muscles increased from one in the 2nd session to 2/3 in the 4th session.
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    Method of assessment - Visual analogue scale
    Time Frame
    At the beginning
    Title
    Pain intensity
    Description
    Method of assessment - Visual analogue scale
    Time Frame
    5 weeks
    Secondary Outcome Measure Information:
    Title
    Neck pain frequency
    Description
    Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
    Time Frame
    At the beginning
    Title
    Neck pain frequency
    Description
    Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
    Time Frame
    5 weeks
    Title
    Neck pain duration
    Description
    Method of assessment - a question on neck pain duration (how long have you have neck pain?)
    Time Frame
    At the beginning
    Title
    Neck pain duration
    Description
    Method of assessment - a question on neck pain duration (how long have you have neck pain?)
    Time Frame
    5 weeks
    Title
    Neck pain associated disability
    Description
    Method of assessment - a disability index with 5 questions on neck pain associated disability
    Time Frame
    At the beginning
    Title
    Neck pain associated disability
    Description
    Method of assessment - a disability index with 5 questions on neck pain associated disability
    Time Frame
    5 weeks
    Title
    Neck flexor muscles endurance test
    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
    Neck flexor muscles endurance test
    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 extensor muscles endurance test
    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 extensor muscles endurance test
    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 test
    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 test
    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
    State-trait anxiety inventory
    Description
    Method of assessment - scale
    Time Frame
    At the beginning
    Title
    State-trait anxiety inventory
    Description
    Method of assessment - scale
    Time Frame
    5 weeks
    Title
    Pain Catastrophizing Scale
    Description
    Method of assessment - scale
    Time Frame
    At the beginning
    Title
    Pain Catastrophizing Scale
    Description
    Method of assessment - scale
    Time Frame
    5 weeks
    Title
    Neurophysiology of pain questionnaire
    Description
    Method of assessment - questionnaire
    Time Frame
    At the beginning
    Title
    Neurophysiology of pain questionnaire
    Description
    Method of assessment - questionnaire
    Time Frame
    5 weeks
    Title
    Patients' Global Impression of Change
    Description
    Method of assessment - scale
    Time Frame
    5 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To be invited to enter the study participants had to have chronic idiopathic neck/shoulder pain, defined as pain felt in the neck/shoulder regions at least once a week in the previous 3 months. Exclusion Criteria: No exclusion criteria

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain

    We'll reach out to this number within 24 hrs