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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03362333
Other study ID # PCEDCSS-FMUP 18
Secondary ID
Status Completed
Phase N/A
First received November 28, 2017
Last updated December 4, 2017
Start date October 1, 2015
Est. completion date October 30, 2016

Study information

Verified date December 2017
Source Aveiro University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date October 30, 2016
Est. primary completion date February 28, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Aveiro University

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity Measured using the visual analogue scale At the beginning
Primary Pain intensity Measured using the visual analogue scale 5 weeks
Primary Pain intensity Measured using the visual analogue scale At 3 months
Secondary Deep neck flexor endurance 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
Secondary Deep neck flexor endurance 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
Secondary Neck extensors endurance 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
Secondary Neck extensors endurance 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
Secondary Scapular stabilizers endurance 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
Secondary Scapular stabilizers endurance 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
Secondary Pressure pain thresholds 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
Secondary Pressure pain thresholds 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
Secondary Disability Method of assessment - the neck pain disability index At the beginning
Secondary Disability Method of assessment - the neck pain disability index 5 weeks
Secondary Disability Method of assessment - the neck pain disability index 3 months
Secondary catastrophizing Method of assessment - Pain catastrophising scale at beginning
Secondary catastrophizing Method of assessment - Pain catastrophising scale 5 weeks
Secondary catastrophizing Method of assessment - Pain catastrophising scale 3 months
Secondary fear of movement method of assessment - the Tampa Scale At the beginning
Secondary fear of movement method of assessment - the Tampa Scale 5 weeks
Secondary fear of movement method of assessment - the Tampa Scale 3 months
Secondary Knowledge of pain neurophysiology method of assessment - scale; the neurophysiology of pain questionnaire at beginning
Secondary Knowledge of pain neurophysiology method of assessment - scale; the neurophysiology of pain questionnaire 5 weeks
Secondary Knowledge of pain neurophysiology method of assessment - scale; the neurophysiology of pain questionnaire 3 months
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