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

Tracking Information

• First Submitted Date: November 28, 2017
• First Posted Date: December 5, 2017
• Last Update Posted Date: December 5, 2017
• Actual Study Start Date: October 1, 2015
• Actual Primary Completion Date: February 28, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pain Neuroscience Education and Exercise
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Neck Pain

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.
• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 4, 2017): 52
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 30, 2016
• Actual Primary Completion Date: February 28, 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03362333
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Anabela G Silva, Aveiro University
• Study Sponsor: Aveiro University
• Collaborators: Not Provided

Investigators

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

• PRS Account: Aveiro University
• Verification Date: December 2017