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

NCT ID: NCT04125901

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-11-30

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.

Conditions

Chronic Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pain Neuroscience Education and Exercise

Intervention Type: OTHER

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

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.

Group Type: OTHER

Exercise

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Science and Technology, Portugal

OTHER

Sponsor Role: collaborator

Aveiro University

OTHER

Sponsor Role: lead

Responsible Party

Rosa Andias

Physiotherapist (Master)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rosa Andias, MD

Role: PRINCIPAL_INVESTIGATOR

University of Aveiro

Locations

Adolfo Portela High School

Aveiro, , Portugal

Dr. Jaime Magalhães Lima High School

Aveiro, , Portugal

José Estevão High School

Aveiro, , Portugal

Countries

Portugal

Other Identifiers

24092019

Identifier Type: -

Identifier Source: org_study_id