Pain Neuroscience Education and Exercise

• ClinicalTrials.gov Identifier: NCT03362333
• Recruitment Status: Completed
• First Posted: December 5, 2017
• Last Update Posted: December 5, 2017
• Sponsor: Aveiro University
• Information provided by (Responsible Party): Anabela G Silva, Aveiro University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Neck Pain	Other: Exercise; Other: Pain neuroscience education	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pain Neuroscience Education and Exercise Versus Exercise for University Students With Chronic Idiopathic Neck Pain: a Randomized, Controlled and Single Blind Study
• Actual Study Start Date: October 1, 2015
• Actual Primary Completion Date: February 28, 2016
• Actual Study Completion Date: October 30, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: pain neuroscience education and exercise; This group received pain neuroscience education and exercise once a week over 4 weeks	Other: Exercise; Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular stabilizer muscles.; Other: Pain neuroscience education; 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	Other: Exercise; Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular stabilizer muscles.

Outcome Measures

Primary Outcome Measures :

1. Pain intensity [ Time Frame: At the beginning ]
   Measured using the visual analogue scale
2. Pain intensity [ Time Frame: 5 weeks ]
   Measured using the visual analogue scale
3. Pain intensity [ Time Frame: At 3 months ]
   Measured using the visual analogue scale

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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. 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.
6. 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.
7. 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.
8. 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.
9. Disability [ Time Frame: At the beginning ]
   Method of assessment - the neck pain disability index
10. Disability [ Time Frame: 5 weeks ]
    Method of assessment - the neck pain disability index
11. Disability [ Time Frame: 3 months ]
    Method of assessment - the neck pain disability index
12. catastrophizing [ Time Frame: at beginning ]
    Method of assessment - Pain catastrophising scale
13. catastrophizing [ Time Frame: 5 weeks ]
    Method of assessment - Pain catastrophising scale
14. catastrophizing [ Time Frame: 3 months ]
    Method of assessment - Pain catastrophising scale
15. fear of movement [ Time Frame: At the beginning ]
    method of assessment - the Tampa Scale
16. fear of movement [ Time Frame: 5 weeks ]
    method of assessment - the Tampa Scale
17. fear of movement [ Time Frame: 3 months ]
    method of assessment - the Tampa Scale
18. Knowledge of pain neurophysiology [ Time Frame: at beginning ]
    method of assessment - scale; the neurophysiology of pain questionnaire
19. Knowledge of pain neurophysiology [ Time Frame: 5 weeks ]
    method of assessment - scale; the neurophysiology of pain questionnaire
20. Knowledge of pain neurophysiology [ Time Frame: 3 months ]
    method of assessment - scale; the neurophysiology of pain questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Aveiro University

Investigators

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

More Information

• Responsible Party: Anabela G Silva, Dr, Aveiro University
• ClinicalTrials.gov Identifier: NCT03362333
• Other Study ID Numbers: PCEDCSS-FMUP 18
• First Posted: December 5, 2017
• Last Update Posted: December 5, 2017
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neck Pain; Pain; Neurologic Manifestations