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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

Tracking Information
First Submitted Date  ICMJE November 28, 2017
First Posted Date  ICMJE December 5, 2017
Last Update Posted Date December 5, 2017
Actual Study Start Date  ICMJE October 1, 2015
Actual Primary Completion Date February 28, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
  • Pain intensity [ Time Frame: At the beginning ]
    Measured using the visual analogue scale
  • Pain intensity [ Time Frame: 5 weeks ]
    Measured using the visual analogue scale
  • Pain intensity [ Time Frame: At 3 months ]
    Measured using the visual analogue scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Disability [ Time Frame: At the beginning ]
    Method of assessment - the neck pain disability index
  • Disability [ Time Frame: 5 weeks ]
    Method of assessment - the neck pain disability index
  • Disability [ Time Frame: 3 months ]
    Method of assessment - the neck pain disability index
  • catastrophizing [ Time Frame: at beginning ]
    Method of assessment - Pain catastrophising scale
  • catastrophizing [ Time Frame: 5 weeks ]
    Method of assessment - Pain catastrophising scale
  • catastrophizing [ Time Frame: 3 months ]
    Method of assessment - Pain catastrophising scale
  • fear of movement [ Time Frame: At the beginning ]
    method of assessment - the Tampa Scale
  • fear of movement [ Time Frame: 5 weeks ]
    method of assessment - the Tampa Scale
  • fear of movement [ Time Frame: 3 months ]
    method of assessment - the Tampa Scale
  • Knowledge of pain neurophysiology [ Time Frame: at beginning ]
    method of assessment - scale; the neurophysiology of pain questionnaire
  • Knowledge of pain neurophysiology [ Time Frame: 5 weeks ]
    method of assessment - scale; the neurophysiology of pain questionnaire
  • Knowledge of pain neurophysiology [ Time Frame: 3 months ]
    method of assessment - scale; the neurophysiology of pain questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Neuroscience Education and Exercise
Official Title  ICMJE Pain Neuroscience Education and Exercise Versus Exercise for University Students With Chronic Idiopathic Neck Pain: a Randomized, Controlled and Single Blind Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neck Pain
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: pain neuroscience education and exercise
    This group received pain neuroscience education and exercise once a week over 4 weeks
    Interventions:
    • Other: Exercise
    • Other: Pain neuroscience education
  • Active Comparator: Exercise
    This group received exercise directed at the neck and shoulder regions once a week over 4 weeks
    Intervention: Other: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2017)
52
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 30, 2016
Actual Primary Completion Date February 28, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03362333
Other Study ID Numbers  ICMJE PCEDCSS-FMUP 18
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anabela G Silva, Aveiro University
Study Sponsor  ICMJE Aveiro University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anabela Silva, PhD University of Aveiro
PRS Account Aveiro University
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP