Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain

July 6, 2016 updated by: Anabela G Silva, Aveiro University

Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain: a School-based Pilot, Randomised and Controlled Study

This study compared the effectiveness of pain neurophysiology education and neck/shoulder exercises with no intervention in adolescents with chronic idiopathic neck pain (CINP).

Study Overview

Status

Completed

Conditions

Detailed Description

Forty three adolescents with chronic idiopathic neck pain were randomly allocated to receive pain neurophysiology education and shoulder/neck exercises (n=21) or no intervention (n=22). Data on pain intensity (Visual Analogue Scale), pain disability, neck flexor and extensor muscles endurance, scapulae stabilizers endurance, pain catastrophizing (Pain catastrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and knowledge of pain neurophysiology (Neurophysiology of Pain Questionnaire) were collected. Measurements were taken before and after the intervention.

Statistical analysis were performed using a mixed-methods ANOVA.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • To be invited to enter the study participants had to have chronic idiopathic neck/shoulder pain, defined as pain felt in the neck/shoulder regions at least once a week in the previous 3 months.

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Education and exercise
The intervention included neurophysiology of pain education and exercises.

Pain neurophysiology education covered the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. It was delivered in small groups (4 to 7 participants). A total of 4 sessions were delivered over 4 weeks (1 session per week). Each session took between 45 minutes and 1 hour.

Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular muscles delivered over 3 sessions (the first session covered pain neurophysiology education only). Each exercise was performed in 3 series of 10 repetitions. The number of exercises targeting the same group of muscles increased from one in the 2nd session to 2/3 in the 4th session.

NO_INTERVENTION: No intervention
This group received no intervention as participants were students that were not seeking treatment for their pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: At the beginning
Method of assessment - Visual analogue scale
At the beginning
Pain intensity
Time Frame: 5 weeks
Method of assessment - Visual analogue scale
5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck pain frequency
Time Frame: At the beginning
Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
At the beginning
Neck pain frequency
Time Frame: 5 weeks
Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
5 weeks
Neck pain duration
Time Frame: At the beginning
Method of assessment - a question on neck pain duration (how long have you have neck pain?)
At the beginning
Neck pain duration
Time Frame: 5 weeks
Method of assessment - a question on neck pain duration (how long have you have neck pain?)
5 weeks
Neck pain associated disability
Time Frame: At the beginning
Method of assessment - a disability index with 5 questions on neck pain associated disability
At the beginning
Neck pain associated disability
Time Frame: 5 weeks
Method of assessment - a disability index with 5 questions on neck pain associated disability
5 weeks
Neck flexor muscles endurance test
Time Frame: At the beginning
Method of assessment - physical test; the participant is in supine and he/she is asked to flex the upper cervical spine, move their head away from the couch approximately 2.5 cm and then maintain this position for as long as possible. The test result is the time (in seconds) that each participant holds the position.
At the beginning
Neck flexor muscles endurance test
Time Frame: 5 weeks
Method of assessment - physical test; the participant is in supine and he/she is asked to flex the upper cervical spine, move their head away from the couch approximately 2.5 cm and then maintain this position for as long as possible. The test result is the time (in seconds) that each participant holds the position.
5 weeks
Neck extensor muscles endurance test
Time Frame: At the beginning
Method of assessment - physical test; the participant is in prone and position, head neutral, and supporting 2 Kg weight hanging from it. Participants were asked to support this weight for as long as possible while maintaining the neutral head positioning. The test result is the time (in seconds) that each participant holds the position.
At the beginning
Neck extensor muscles endurance test
Time Frame: 5 weeks
Method of assessment - physical test; the participant is in prone and position, head neutral, and supporting 2 Kg weight hanging from it. Participants were asked to support this weight for as long as possible while maintaining the neutral head positioning. The test result is the time (in seconds) that each participant holds the position.
5 weeks
Scapular stabilizers' endurance test
Time Frame: At the beginning
Method of assessment - physical test; Method of assessment - physical test; Participants were standing with the shoulders and elbows flexed at 90º, while pulling both extremities of a dynamometer to reach 1 Kg of force. The test result is the time (in seconds) that each participants was able to hold this position.
At the beginning
Scapular stabilizers' endurance test
Time Frame: 5 weeks
Method of assessment - physical test; Method of assessment - physical test; Participants were standing with the shoulders and elbows flexed at 90º, while pulling both extremities of a dynamometer to reach 1 Kg of force. The test result is the time (in seconds) that each participants was able to hold this position.
5 weeks
State-trait anxiety inventory
Time Frame: At the beginning
Method of assessment - scale
At the beginning
State-trait anxiety inventory
Time Frame: 5 weeks
Method of assessment - scale
5 weeks
Pain Catastrophizing Scale
Time Frame: At the beginning
Method of assessment - scale
At the beginning
Pain Catastrophizing Scale
Time Frame: 5 weeks
Method of assessment - scale
5 weeks
Neurophysiology of pain questionnaire
Time Frame: At the beginning
Method of assessment - questionnaire
At the beginning
Neurophysiology of pain questionnaire
Time Frame: 5 weeks
Method of assessment - questionnaire
5 weeks
Patients' Global Impression of Change
Time Frame: 5 weeks
Method of assessment - scale
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (ESTIMATE)

July 11, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 11, 2016

Last Update Submitted That Met QC Criteria

July 6, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCEDCSS_FMUP 5/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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