- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02827994
Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain
Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain: a School-based Pilot, Randomised and Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Education and exercise
The intervention included neurophysiology of pain education and exercises.
|
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. |
|
NO_INTERVENTION: No intervention
This group received no intervention as participants were students that were not seeking treatment for their pain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: At the beginning
|
Method of assessment - Visual analogue scale
|
At the beginning
|
|
Pain intensity
Time Frame: 5 weeks
|
Method of assessment - Visual analogue scale
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck pain frequency
Time Frame: At the beginning
|
Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
|
At the beginning
|
|
Neck pain frequency
Time Frame: 5 weeks
|
Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
|
5 weeks
|
|
Neck pain duration
Time Frame: At the beginning
|
Method of assessment - a question on neck pain duration (how long have you have neck pain?)
|
At the beginning
|
|
Neck pain duration
Time Frame: 5 weeks
|
Method of assessment - a question on neck pain duration (how long have you have neck pain?)
|
5 weeks
|
|
Neck pain associated disability
Time Frame: At the beginning
|
Method of assessment - a disability index with 5 questions on neck pain associated disability
|
At the beginning
|
|
Neck pain associated disability
Time Frame: 5 weeks
|
Method of assessment - a disability index with 5 questions on neck pain associated disability
|
5 weeks
|
|
Neck flexor muscles endurance test
Time Frame: At the beginning
|
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.
|
At the beginning
|
|
Neck flexor muscles endurance test
Time Frame: 5 weeks
|
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.
|
5 weeks
|
|
Neck extensor muscles endurance test
Time Frame: At the beginning
|
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.
|
At the beginning
|
|
Neck extensor muscles endurance test
Time Frame: 5 weeks
|
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.
|
5 weeks
|
|
Scapular stabilizers' endurance test
Time Frame: At the beginning
|
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.
|
At the beginning
|
|
Scapular stabilizers' endurance test
Time Frame: 5 weeks
|
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.
|
5 weeks
|
|
State-trait anxiety inventory
Time Frame: At the beginning
|
Method of assessment - scale
|
At the beginning
|
|
State-trait anxiety inventory
Time Frame: 5 weeks
|
Method of assessment - scale
|
5 weeks
|
|
Pain Catastrophizing Scale
Time Frame: At the beginning
|
Method of assessment - scale
|
At the beginning
|
|
Pain Catastrophizing Scale
Time Frame: 5 weeks
|
Method of assessment - scale
|
5 weeks
|
|
Neurophysiology of pain questionnaire
Time Frame: At the beginning
|
Method of assessment - questionnaire
|
At the beginning
|
|
Neurophysiology of pain questionnaire
Time Frame: 5 weeks
|
Method of assessment - questionnaire
|
5 weeks
|
|
Patients' Global Impression of Change
Time Frame: 5 weeks
|
Method of assessment - scale
|
5 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCEDCSS_FMUP 5/2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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