Clinical trial NCT04125901: Pain Neuroscience Education and Exercise in High School Students With Chronic Idiopathic Neck Pain
Official title: Chronic Idiopathic Neck Pain in High School Students: Effectiveness of an Intervention Based on Exercise and Pain Neuroscience Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Keywords: Chronic Neck Pain
Adolescents
Pain Neuroscience Education
Exercise
Lead sponsor: Aveiro University
Sponsor class: OTHER
Collaborators: name: Foundation for Science and Technology, Portugal
First posted: 2019-10-14
Enrollment: 127
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Intensity of pain
timeFrame: Baseline
measure: Intensity of pain
timeFrame: 8 weeks
measure: Intensity of pain
timeFrame: 6 months
Secondary outcomes:
measure: Pain location
timeFrame: Baseline
measure: Pain location
timeFrame: 8 weeks
measure: Pain location
timeFrame: 6 months
measure: Pain frequency
timeFrame: Baseline
measure: Pain frequency
timeFrame: 8 weeks
measure: Pain frequency
timeFrame: 6 months
measure: Physical activity
timeFrame: Baseline
measure: Physical activity
timeFrame: 8 weeks
measure: Physical activity
timeFrame: 6 months
measure: Disability
timeFrame: Baseline
measure: Disability
timeFrame: 8 weeks
measure: Disability
timeFrame: 6 months
measure: Sleep
timeFrame: Baseline
measure: Sleep
timeFrame: 8 weeks
measure: Sleep
timeFrame: 6 months
measure: Pain catastrophizing
timeFrame: Baseline
measure: Pain catastrophizing
timeFrame: 8 weeks
measure: Pain catastrophizing
timeFrame: 6 months
measure: Fear of movement
timeFrame: Baseline
measure: Fear of movement
timeFrame: 8 weeks
measure: Fear of movement
timeFrame: 6 months
measure: Self-efficacy
timeFrame: Baseline
measure: Self-efficacy
timeFrame: 8 weeks
measure: Self-efficacy
timeFrame: 6 months
measure: Central Sensitization
timeFrame: Baseline
measure: Central Sensitization
timeFrame: 8 weeks
measure: Central Sensitization
timeFrame: 6 months
measure: Knowledge of pain neuroscience
timeFrame: Baseline
measure: Knowledge of pain neuroscience
timeFrame: 8 weeks
measure: Knowledge of pain neuroscience
timeFrame: 6 months
measure: Muscular resistance of the deep flexor muscles of the cervical
timeFrame: Baseline
measure: Muscular resistance of the deep flexor muscles of the cervical
timeFrame: 8 weeks
measure: Muscular resistance of the deep flexor muscles of the cervical
timeFrame: 6 months
measure: Muscular endurance of the deep cervical extensor muscles
timeFrame: Baseline
measure: Muscular endurance of the deep cervical extensor muscles
timeFrame: 8 weeks
measure: Muscular endurance of the deep cervical extensor muscles
timeFrame: 6 months
measure: Muscular resistance of the stabilizing muscles of the scapular girdle
timeFrame: Baseline
measure: Muscular resistance of the stabilizing muscles of the scapular girdle
timeFrame: 8 weeks
measure: Muscular resistance of the stabilizing muscles of the scapular girdle
timeFrame: 6 months
measure: Pressure Pain Threshold
timeFrame: Baseline
measure: Pressure Pain Threshold
timeFrame: 8 weeks
measure: Pressure Pain Threshold
timeFrame: 6 months
Other outcomes:
Locations:
city: Aveiro
country: Portugal
facility: Adolfo Portela High School
city: Aveiro
country: Portugal
facility: Dr. Jaime Magalhães Lima High School
city: Aveiro
country: Portugal
facility: José Estevão High School
Study officials:
affiliation: University of Aveiro
name: Rosa Andias, MD
role: PRINCIPAL_INVESTIGATOR
References: