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Completed

NCT Number: NCT02827994

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

This study compared the effectiveness of pain neurophysiology education and neck/shoulder exercises with no intervention in adolescents with chronic idiopathic neck pain (CINP).

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neurophysiology of pain education and exercises

Other

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 outcomes

  1. Pain intensity

    Time frame: At the beginning

    Method of assessment - Visual analogue scale

  2. Pain intensity

    Time frame: 5 weeks

    Method of assessment - Visual analogue scale

Secondary outcomes

  1. 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)

  2. 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)

  3. Neck pain duration

    Time frame: At the beginning

    Method of assessment - a question on neck pain duration (how long have you have neck pain?)

  4. Neck pain duration

    Time frame: 5 weeks

    Method of assessment - a question on neck pain duration (how long have you have neck pain?)

  5. Neck pain associated disability

    Time frame: At the beginning

    Method of assessment - a disability index with 5 questions on neck pain associated disability

  6. Neck pain associated disability

    Time frame: 5 weeks

    Method of assessment - a disability index with 5 questions on neck pain associated disability

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. State-trait anxiety inventory

    Time frame: At the beginning

    Method of assessment - scale

  14. State-trait anxiety inventory

    Time frame: 5 weeks

    Method of assessment - scale

  15. Pain Catastrophizing Scale

    Time frame: At the beginning

    Method of assessment - scale

  16. Pain Catastrophizing Scale

    Time frame: 5 weeks

    Method of assessment - scale

  17. Neurophysiology of pain questionnaire

    Time frame: At the beginning

    Method of assessment - questionnaire

  18. Neurophysiology of pain questionnaire

    Time frame: 5 weeks

    Method of assessment - questionnaire

  19. Patients' Global Impression of Change

    Time frame: 5 weeks

    Method of assessment - scale

Sponsors and collaborators

Lead sponsor

Aveiro University

Other

Registry information

Official study title

Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain: a School-based Pilot, Randomised and Controlled Study

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2016
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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