Pain Neuroscience Education and Exercise

December 4, 2017 updated by: Anabela G Silva, Aveiro University

Pain Neuroscience Education and Exercise Versus Exercise for University Students With Chronic Idiopathic Neck Pain: a Randomized, Controlled and Single Blind Study

This study examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain.

Study Overview

Status

Completed

Conditions

Detailed Description

This study examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain.

University students with chronic neck pain were randomly allocated to receive pain neuroscience education and exercise or exercise only and assessed at baseline, after the intervention and at 3 months follow up. Outcome variables were pain intensity (primary outcome), disability, fear of movement, catastrophizing, knowledge of pain neurophysiology, pressure pain thresholds and neck and scapular muscle endurance.

Study Type

Interventional

Enrollment (Actual)

52

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants could enter the study if they had chronic idiopathic neck pain, defined as pain felt in the neck at least once a week in the previous 3 months and for which no cause had been established. Furthermore, they were required to have a minimum pain intensity in the previous week of 2 in the visual analogue scale.

Exclusion Criteria:

  • Participants were excluded if they had had physiotherapy for their neck pain in the 6 months previous to the study, if they had rheumatic, nervous, cardiac and/or respiratory pathology that could prevent or make it difficult to do the exercises. Exclusion criteria were ascertained by self-report.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pain neuroscience education and exercise
This group received pain neuroscience education and exercise once a week over 4 weeks
Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular stabilizer muscles.
Pain neuroscience education covered the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience.
Active Comparator: Exercise
This group received exercise directed at the neck and shoulder regions once a week over 4 weeks
Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular stabilizer muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: At the beginning
Measured using the visual analogue scale
At the beginning
Pain intensity
Time Frame: 5 weeks
Measured using the visual analogue scale
5 weeks
Pain intensity
Time Frame: At 3 months
Measured using the visual analogue scale
At 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deep neck flexor endurance
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
Deep neck flexor endurance
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 extensors endurance
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 extensors endurance
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
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
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
Pressure pain thresholds
Time Frame: At the beginning
Method of assessment - psychophysical test; Pressure was applied over the trapezius and at C5-C6 with a algometer until the participant first felt pain. The results was the quantity of force (in Kgf) supported by participants.
At the beginning
Pressure pain thresholds
Time Frame: 5 weeks
Method of assessment - psychophysical test; Pressure was applied over the trapezius and at C5-C6 with a algometer until the participant first felt pain. The results was the quantity of force (in Kgf) supported by participants.
5 weeks
Disability
Time Frame: At the beginning
Method of assessment - the neck pain disability index
At the beginning
Disability
Time Frame: 5 weeks
Method of assessment - the neck pain disability index
5 weeks
Disability
Time Frame: 3 months
Method of assessment - the neck pain disability index
3 months
catastrophizing
Time Frame: at beginning
Method of assessment - Pain catastrophising scale
at beginning
catastrophizing
Time Frame: 5 weeks
Method of assessment - Pain catastrophising scale
5 weeks
catastrophizing
Time Frame: 3 months
Method of assessment - Pain catastrophising scale
3 months
fear of movement
Time Frame: At the beginning
method of assessment - the Tampa Scale
At the beginning
fear of movement
Time Frame: 5 weeks
method of assessment - the Tampa Scale
5 weeks
fear of movement
Time Frame: 3 months
method of assessment - the Tampa Scale
3 months
Knowledge of pain neurophysiology
Time Frame: at beginning
method of assessment - scale; the neurophysiology of pain questionnaire
at beginning
Knowledge of pain neurophysiology
Time Frame: 5 weeks
method of assessment - scale; the neurophysiology of pain questionnaire
5 weeks
Knowledge of pain neurophysiology
Time Frame: 3 months
method of assessment - scale; the neurophysiology of pain questionnaire
3 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Anabela Silva, PhD, University of Aveiro

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 (Actual)

October 1, 2015

Primary Completion (Actual)

February 28, 2016

Study Completion (Actual)

October 30, 2016

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

December 4, 2017

First Posted (Actual)

December 5, 2017

Study Record Updates

Last Update Posted (Actual)

December 5, 2017

Last Update Submitted That Met QC Criteria

December 4, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCEDCSS-FMUP 18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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