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
About this trial
This is an interventional treatment trial for Neck Pain
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
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
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
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