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Pain Neuroscience Education and Exercise

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

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.

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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

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362333


Sponsors and Collaborators
Aveiro University
Investigators
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Principal Investigator: Anabela Silva, PhD University of Aveiro
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Responsible Party: Anabela G Silva, Dr, Aveiro University
ClinicalTrials.gov Identifier: NCT03362333    
Other Study ID Numbers: PCEDCSS-FMUP 18
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations