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
1 other identifier
interventional
127
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedFirst Posted
Study publicly available on registry
October 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedFebruary 23, 2021
February 1, 2021
9 months
October 1, 2019
February 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (42)
Pain location
Baseline
Pain location
8 weeks
Pain location
6 months
Pain frequency
Baseline
Pain frequency
8 weeks
- +37 more secondary outcomes
Study Arms (2)
Pain Neuroscience Education and Exercise
EXPERIMENTALParticipants 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.
Exercise
OTHERParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aveiro Universitylead
- Foundation for Science and Technology, Portugalcollaborator
Study Sites (3)
Adolfo Portela High School
Aveiro, Portugal
Dr. Jaime Magalhães Lima High School
Aveiro, Portugal
José Estevão High School
Aveiro, Portugal
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rosa Andias, MD
University of Aveiro
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physiotherapist (Master)
Study Record Dates
First Submitted
October 1, 2019
First Posted
October 14, 2019
Study Start
October 1, 2019
Primary Completion
June 30, 2020
Study Completion
November 30, 2020
Last Updated
February 23, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share