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

Chronic Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04125901
• Other study ID #: 24092019
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2021
• Source: Aveiro University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: November 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 20 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Neck Pain
• Neck Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Portugal	Adolfo Portela High School	Aveiro
Portugal	Dr. Jaime Magalhães Lima High School	Aveiro
Portugal	José Estevão High School	Aveiro

Sponsors (2)

Lead Sponsor	Collaborator
Aveiro University	Foundation for Science and Technology (Portugal)

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Pain location	Assessed using a body chart where the patients identifies the painful body segments	Baseline
Secondary	Pain location	Assessed using a body chart where the patients identifies the painful body segments	8 weeks
Secondary	Pain location	Assessed using a body chart where the patients identifies the painful body segments	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Disability	Assessed using the Functional Disability Inventory (Total score range from 0-60 and higher scores are indicative of greater pain-related disability)	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pain catastrophizing	Assessed using the Pain Catastrophizing Scale (Total score range from 0-52 and higher values are indicative of higher pain catastrophizing)	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pressure Pain Threshold	Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)	Baseline
Secondary	Pressure Pain Threshold	Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)	8 weeks
Secondary	Pressure Pain Threshold	Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)	6 months