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Completed

NCT Number: NCT04125901

Pain Neuroscience Education and Exercise in High School Students With Chronic Idiopathic Neck Pain

Musculoskeletal pain can affect up to 40% of children and adolescents. Neck pain (NP) is one of the most prevalent painful conditions and evidence suggests that its prevalence has increased in recent decades in adolescents aged 16 to 18 years, from 22.9% in 1991 to 29.5% in 2011. Interventions based on pain neuroscience education have emerged as promising strategies in chronic pain conditions.In adults this intervention has been explored in many pain conditions, including musculoskeletal pain, but there is only one pilot study in adolescents with chronic NP and one case study in adolescents with fibromyalgia.

Thus, the main objective of the present study is:

(i) To compare the effectiveness of an education program based on pain neuroscience education and exercise versus exercise alone, in decreasing pain intensity in secondary school students with chronic and idiopathic NP immediately after the intervention and at 6 months.

The secondary objectives are to:

i) Compare the effectiveness of these programs immediately after the intervention and at 6 months in i) disability, ii) sleep, iii) pain catastrophizing, iv) fear of movement, v) self-efficacy, vi) central sensitization vii) the strength of the deep neck flexors and extensors muscles and stabilizers of the scapula; and viii) the pressure pain threshold between the two intervention groups;

ii) Explore possible predictors of response to treatment.

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Key information

Conditions

Chronic Neck Pain Behavior Motor Activity

Age range

13 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adolfo Portela High School, Aveiro, Portugal

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About this study

It is anticipated that the sample will consist of 127 participants from four secondary schools that will be divided into two groups. Both groups will receive the same exercise-based intervention. The experimental group will receive, in addition to exercise, an intervention based on pain neuroscience education. The intervention will consist of 1 session per week during 8 weeks and will be applied in small groups.

The intervention will be performed in a blended-learning format. Five sessions will be face-to-face with up to 45 minutes duration, performed at school and incorporated into physical education classes and 3 will be performed at home, supported by vídeos sent by WhatsApp. The first two sessions will always be face-to-face. Face-to-face sessions will be interspersed with WhatsApp sessions.

Participants will be assessed, by online questionnaires, for sociodemographic aspects, pain characterization and physical activity level, disability, sleep, catastrophizing, fear of movement, self-efficacy, central sensitization and knowledge on pain neurophysiology. In addition, 3 muscle tests will be performed for the deep neck flexor and extensor muscles and scapular stabilizers, and the pressure pain thresholds in the neck and at distance will be assessed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Students with chronic and idiopathic NP for at least 3 months
  • Have a pain intensity of NPS greater than or equal to 2
  • Not receiving any treatment for NP (except analgesic)

Exclusion criteria

  • All students with nervous or rheumatic system pathology
  • Students attending special education (because they may need more accompaniment which, in this group intervention, will not be possible)

Treatment and study plan

Pain Neuroscience Education and Exercise

Other

The incorporation of the exercise in this group will be gradual, in order to decrease the education component and increase the exercise component (up to 45/60 minutes). The 1st session will be only PNE and will last approximately 45 minutes. In the 2nd session, there will be 30 minutes of PNE and the remaining 15 minutes of exercise. In the following 4th and 6th sessions, 15 minutes of each session will be used to clarify doubts and emphasize PNE concepts and strategies. The 8th session will include exercises only. In WhatsApp sessions, in addition to the video with the exercises, participants will receive activities about the PNE.

Exercise

Other

The exercise group will perform exercises in all sessions (45 minutes of exercise in face-to-face sessions). In WhatsApp sessions, participants will receive a video with exercises to perform at home.

Primary outcomes

  1. Intensity of pain

    Time frame: Baseline

    Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)

  2. Intensity of pain

    Time frame: 8 weeks

    Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)

  3. Intensity of pain

    Time frame: 6 months

    Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)

Secondary outcomes

  1. Pain location

    Time frame: Baseline

    Assessed using a body chart where the patients identifies the painful body segments

  2. Pain location

    Time frame: 8 weeks

    Assessed using a body chart where the patients identifies the painful body segments

  3. Pain location

    Time frame: 6 months

    Assessed using a body chart where the patients identifies the painful body segments

  4. Pain frequency

    Time frame: Baseline

    Assessed using a closed question about pain frequency in the last week. (How many times in the last week have you felt this pain?". The answer options are: Never, rarely (once a week) occasionally (2 to 3 times a week), often (more than 3 times a week) and always.

  5. Pain frequency

    Time frame: 8 weeks

    Assessed using a closed question about neck pain frequency in the last week (How many times in the last week have you felt this pain?". The answer options are: Never, rarely (once a week) occasionally (2 to 3 times a week), often (more than 3 times a week) and always.

  6. Pain frequency

    Time frame: 6 months

    Assessed using a closed question about neck pain frequency in the last week (How many times in the last week have you felt this pain?". The answer options are: Never, rarely (once a week) occasionally (2 to 3 times a week), often (more than 3 times a week) and always.

  7. Physical activity

    Time frame: Baseline

    Assessed using two questions regarding moderate or vigorous physical activity during the week ("In addition to your physical education classes, did you perform any other moderate physical activity?" and "In addition to your physical education classes, did you perform any other vigorous physical activity?") adapted by Silva et al. 2017.

  8. Physical activity

    Time frame: 8 weeks

    Assessed using two questions regarding moderate or vigorous physical activity during the week ("In addition to your physical education classes, did you perform any other moderate physical activity?" and "In addition to your physical education classes, did you perform any other vigorous physical activity?") adapted by Silva et al. 2017.

  9. Physical activity

    Time frame: 6 months

    Assessed using two questions regarding moderate or vigorous physical activity during the week ("In addition to your physical education classes, did you perform any other moderate physical activity?" and "In addition to your physical education classes, did you perform any other vigorous physical activity?") adapted by Silva et al. 2017.

  10. Disability

    Time frame: Baseline

    Assessed using the Functional Disability Inventory (Total score range from 0-60 and higher scores are indicative of greater pain-related disability)

  11. Disability

    Time frame: 8 weeks

    Assessed using the Functional Disability Inventory (Total score range from 0-60 and higher scores are indicative of greater pain-related disability)

  12. Disability

    Time frame: 6 months

    Assessed using the Functional Disability Inventory (Total score range from 0-60 and higher scores are indicative of greater pain-related disability)

  13. Sleep

    Time frame: Baseline

    Assessed using the Basic Scale of Symptoms of Insomnia and Sleep Quality (Total score range from 0-28 and higher scores are indicative of poorer sleep quality)

  14. Sleep

    Time frame: 8 weeks

    Assessed using the Basic Scale of Symptoms of Insomnia and Sleep Quality (Total score range from 0-28 and higher scores are indicative of poorer sleep quality)

  15. Sleep

    Time frame: 6 months

    Assessed using the Basic Scale of Symptoms of Insomnia and Sleep Quality (Total score range from 0-28 and higher scores are indicative of poorer sleep quality)

  16. Pain catastrophizing

    Time frame: Baseline

    Assessed using the Pain Catastrophizing Scale (Total score range from 0-52 and higher values are indicative of higher pain catastrophizing)

  17. Pain catastrophizing

    Time frame: 8 weeks

    Assessed using the Pain Catastrophizing Scale (Total score range from 0-52 and higher values are indicative of higher pain catastrophizing)

  18. Pain catastrophizing

    Time frame: 6 months

    Assessed using the Pain Catastrophizing Scale (Total score range from 0-52 and higher values are indicative of higher pain catastrophizing)

  19. Fear of movement

    Time frame: Baseline

    Assessed using the Tampa Scale of Kinesiophobia (Total score range from 13-52 and higher values are indicative of higher levels of fear of movement)

  20. Fear of movement

    Time frame: 8 weeks

    Assessed using the Tampa Scale of Kinesiophobia (Total score range from 13-52 and higher values are indicative of higher levels of fear of movement)

  21. Fear of movement

    Time frame: 6 months

    Assessed using the Tampa Scale of Kinesiophobia (Total score range from 13-52 and higher values are indicative of higher levels of fear of movement)

  22. Self-efficacy

    Time frame: Baseline

    Assessed using the Self-Efficacy Pain Scale (Total score range from 7 to 35 points and lower scores are indicate of greater self-efficacy)

  23. Self-efficacy

    Time frame: 8 weeks

    Assessed using the Self-Efficacy Pain Scale (Total score range from 7 to 35 points and lower scores are indicate of greater self-efficacy)

  24. Self-efficacy

    Time frame: 6 months

    Assessed using the Self-Efficacy Pain Scale (Total score range from 7 to 35 points and lower scores are indicate of greater self-efficacy)

  25. Central Sensitization

    Time frame: Baseline

    Assessed using the Central Sensitization Inventory (Total score range from 0 to 100 and higher scores are indicative of a higher degree of symptomatology associated with central sensitization)

  26. Central Sensitization

    Time frame: 8 weeks

    Assessed using the Central Sensitization Inventory (Total score range from 0 to 100 and higher scores are indicative of a higher degree of symptomatology associated with central sensitization)

  27. Central Sensitization

    Time frame: 6 months

    Assessed using the Central Sensitization Inventory (Total score range from 0 to 100 and higher scores are indicative of a higher degree of symptomatology associated with central sensitization)

  28. Knowledge of pain neuroscience

    Time frame: Baseline

    Assessed using the Pain Neurophysiology Questionnaire (Total score range from 0-19 and higher values are indicative of more knowledge on pain neurophysiology)

  29. Knowledge of pain neuroscience

    Time frame: 8 weeks

    Assessed using the Pain Neurophysiology Questionnaire (Total score range from 0-19 and higher values are indicative of more knowledge on pain neurophysiology)

  30. Knowledge of pain neuroscience

    Time frame: 6 months

    Assessed using the Pain Neurophysiology Questionnaire (Total score range from 0-19 and higher values are indicative of more knowledge on pain neurophysiology)

  31. Muscular resistance of the deep flexor muscles of the cervical

    Time frame: Baseline

    Assessed using the Deep Neck Flexor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)

  32. Muscular resistance of the deep flexor muscles of the cervical

    Time frame: 8 weeks

    Assessed using the Deep Neck Flexor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)

  33. Muscular resistance of the deep flexor muscles of the cervical

    Time frame: 6 months

    Assessed using the Deep Neck Flexor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)

  34. Muscular endurance of the deep cervical extensor muscles

    Time frame: Baseline

    Assessed using the Cervical Extensor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)

  35. Muscular endurance of the deep cervical extensor muscles

    Time frame: 8 weeks

    Assessed using the Cervical Extensor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)

  36. Muscular endurance of the deep cervical extensor muscles

    Time frame: 6 months

    Assessed using the Cervical Extensor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)

  37. Muscular resistance of the stabilizing muscles of the scapular girdle

    Time frame: Baseline

    Assessed using the Scapular Muscle Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)

  38. Muscular resistance of the stabilizing muscles of the scapular girdle

    Time frame: 8 weeks

    Assessed using the Scapular Muscle Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)

  39. Muscular resistance of the stabilizing muscles of the scapular girdle

    Time frame: 6 months

    Assessed using the Scapular Muscle Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)

  40. Pressure Pain Threshold

    Time frame: Baseline

    Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)

  41. Pressure Pain Threshold

    Time frame: 8 weeks

    Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)

  42. Pressure Pain Threshold

    Time frame: 6 months

    Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)

Sponsors and collaborators

Lead sponsor

Aveiro University

Other

Collaborators

  • Foundation for Science and Technology, Portugal

Registry information

Official study title

Chronic Idiopathic Neck Pain in High School Students: Effectiveness of an Intervention Based on Exercise and Pain Neuroscience Education

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2019
Registry last updated
Feb 23, 2021

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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