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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Neck Pain
• Intervention / Treatment: Other: Pain Neuroscience Education and Exercise; Other: Exercise

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Aveiro, Portugal
    • Adolfo Portela High School
  • Aveiro, Portugal
    • Dr. Jaime Magalhães Lima High School
  • Aveiro, Portugal
    • José Estevão High School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain Neuroscience Education and Exercise; Participants will received an 8-week intervention consisting of exercise and pain neuroscience education. 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, endurance and strengthening exercises will be performed for the neck and scapulo-thoracic region.	Other: Pain Neuroscience Education and Exercise; 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.
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.	Other: Exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of pain	Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)	Baseline
Intensity of pain	Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)	8 weeks
Intensity of pain	Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain location	Assessed using a body chart where the patients identifies the painful body segments	Baseline
Pain location	Assessed using a body chart where the patients identifies the painful body segments	8 weeks
Pain location	Assessed using a body chart where the patients identifies the painful body segments	6 months
Pain frequency	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.	Baseline
Pain frequency	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.	8 weeks
Pain frequency	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 months
Physical activity	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.	Baseline
Physical activity	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 weeks
Physical activity	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.	6 months
Disability	Assessed using the Functional Disability Inventory (Total score range from 0-60 and higher scores are indicative of greater pain-related disability)	Baseline
Disability	Assessed using the Functional Disability Inventory (Total score range from 0-60 and higher scores are indicative of greater pain-related disability)	8 weeks
Disability	Assessed using the Functional Disability Inventory (Total score range from 0-60 and higher scores are indicative of greater pain-related disability)	6 months
Sleep	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)	Baseline
Sleep	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)	8 weeks
Sleep	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)	6 months
Pain catastrophizing	Assessed using the Pain Catastrophizing Scale (Total score range from 0-52 and higher values are indicative of higher pain catastrophizing)	Baseline
Pain catastrophizing	Assessed using the Pain Catastrophizing Scale (Total score range from 0-52 and higher values are indicative of higher pain catastrophizing)	8 weeks
Pain catastrophizing	Assessed using the Pain Catastrophizing Scale (Total score range from 0-52 and higher values are indicative of higher pain catastrophizing)	6 months
Fear of movement	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)	Baseline
Fear of movement	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)	8 weeks
Fear of movement	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)	6 months
Self-efficacy	Assessed using the Self-Efficacy Pain Scale (Total score range from 7 to 35 points and lower scores are indicate of greater self-efficacy)	Baseline
Self-efficacy	Assessed using the Self-Efficacy Pain Scale (Total score range from 7 to 35 points and lower scores are indicate of greater self-efficacy)	8 weeks
Self-efficacy	Assessed using the Self-Efficacy Pain Scale (Total score range from 7 to 35 points and lower scores are indicate of greater self-efficacy)	6 months
Central Sensitization	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)	Baseline
Central Sensitization	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)	8 weeks
Central Sensitization	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)	6 months
Knowledge of pain neuroscience	Assessed using the Pain Neurophysiology Questionnaire (Total score range from 0-19 and higher values are indicative of more knowledge on pain neurophysiology)	Baseline
Knowledge of pain neuroscience	Assessed using the Pain Neurophysiology Questionnaire (Total score range from 0-19 and higher values are indicative of more knowledge on pain neurophysiology)	8 weeks
Knowledge of pain neuroscience	Assessed using the Pain Neurophysiology Questionnaire (Total score range from 0-19 and higher values are indicative of more knowledge on pain neurophysiology)	6 months
Muscular resistance of the deep flexor muscles of the cervical	Assessed using the Deep Neck Flexor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)	Baseline
Muscular resistance of the deep flexor muscles of the cervical	Assessed using the Deep Neck Flexor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)	8 weeks
Muscular resistance of the deep flexor muscles of the cervical	Assessed using the Deep Neck Flexor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)	6 months
Muscular endurance of the deep cervical extensor muscles	Assessed using the Cervical Extensor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)	Baseline
Muscular endurance of the deep cervical extensor muscles	Assessed using the Cervical Extensor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)	8 weeks
Muscular endurance of the deep cervical extensor muscles	Assessed using the Cervical Extensor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)	6 months
Muscular resistance of the stabilizing muscles of the scapular girdle	Assessed using the Scapular Muscle Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)	Baseline
Muscular resistance of the stabilizing muscles of the scapular girdle	Assessed using the Scapular Muscle Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)	8 weeks
Muscular resistance of the stabilizing muscles of the scapular girdle	Assessed using the Scapular Muscle Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)	6 months
Pressure Pain Threshold	Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)	Baseline
Pressure Pain Threshold	Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)	8 weeks
Pressure Pain Threshold	Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)	6 months

Collaborators and Investigators

• Sponsor: Aveiro University
• Collaborators: Foundation for Science and Technology, Portugal
• Investigators: Principal Investigator: Rosa Andias, MD, University of Aveiro

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Adolescents; Exercise; Chronic Neck Pain; Pain Neuroscience Education
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 24092019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No