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

Overview

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.

Full Title of Study: “Chronic Idiopathic Neck Pain in High School Students: Effectiveness of an Intervention Based on Exercise and Pain Neuroscience Education”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2020

Detailed Description

It is anticipated that the sample will consist of 140 participants from four secondary schools that will be divided into two groups. Both groups will receive an exercise-based intervention. The experimental group will receive, besides 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.

In the experimental group 4 the exercise sessions will be performed at school, incorporated into physical education classes and 4 will be performed at home, supported by videos. In the control group, which will only performed exercise, each participant will participate in 5 presential group sessions at school and the remaining 3 sessions will be performed at home.

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.

Interventions

  • Other: Pain Neuroscience Education and Exercise
    • The experimental group will performed 8 sessions which will included pain neuroscience education. 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).
  • Other: Exercise
    • The experimental group will performed 8 sessions which will included exercise.

Arms, Groups and Cohorts

  • Experimental: Pain Neuroscience Education and Exercise
    • Participants will received an 8 week intervention consisting of pain neuroscience education and exercise. Pain neuroscience education will be conducted in line with international guidelines and will address the following topics: pain neurophysiology, nociception and nociceptive pathways, inhibition and spinal cord stimulation, peripheral and central sensitization, nervous system plasticity and the impact of variables such as stress, anxiety, sleep and exercise on pain behavior. Exercise will be performed in accordance with international guidelines for chronic NP. Motor control, resistance and strengthening exercises will be performed for the neck and scapulo-thoracic region.
  • Other: Exercise
    • Participants will received an 8 week intervention consisting of exercise. The exercise performed in this group will be the same as in the intervention group and will follow the same international guidelines for chronic NP.

Clinical Trial Outcome Measures

Primary Measures

  • 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)
  • 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)
  • 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 Measures

  • Pain location
    • Time Frame: Baseline
    • Assessed using a body chart where the patients identifies the painful body segments
  • Pain location
    • Time Frame: 8 weeks
    • Assessed using a body chart where the patients identifies the painful body segments
  • Pain location
    • Time Frame: 6 months
    • Assessed using a body chart where the patients identifies the painful body segments
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Pressure Pain Threshold
    • Time Frame: Baseline
    • Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)
  • Pressure Pain Threshold
    • Time Frame: 8 weeks
    • Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)
  • Pressure Pain Threshold
    • Time Frame: 6 months
    • Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)

Participating in This Clinical Trial

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)

Gender Eligibility: All

Aged between 15 and 18 years

Minimum Age: 13 Years

Maximum Age: 20 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aveiro University
  • Collaborator
    • Foundation for Science and Technology (Portugal)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rosa Andias, Physiotherapist (Master) – Aveiro University
  • Overall Official(s)
    • Rosa Andias, MD, Principal Investigator, University of Aveiro
  • Overall Contact(s)
    • Rosa Andias, MD, 234370200, rosaandias@ua.pt

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