NCT04125901

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

October 1, 2019

Last Update Submit

February 22, 2021

Conditions

Keywords

Chronic Neck PainAdolescentsPain Neuroscience EducationExercise

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

EXPERIMENTAL

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

Exercise

OTHER

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

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.

Pain Neuroscience Education and 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.

Exercise

Eligibility Criteria

Age13 Years - 20 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAged between 15 and 18 years
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (3)

Adolfo Portela High School

Aveiro, Portugal

Location

Dr. Jaime Magalhães Lima High School

Aveiro, Portugal

Location

José Estevão High School

Aveiro, Portugal

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rosa Andias, MD

    University of Aveiro

    PRINCIPAL INVESTIGATOR

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

Locations