Exercise and Pain Neuroscience Education for Patients With Neck Pain: Impact on Pain and Disability

Overview

This study will compare the effectiveness of pain neuroscience education and neck/shoulder traditional exercises versus pain neuroscience education and neck/shoulder suspension training exercises for patients with chronic idiopathic neck pain (CINP).

Full Title of Study: “Exercise and Pain Neuroscience Education for Patients With Neck Pain: Impact”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 2020

Detailed Description

The investigators anticipate that 66 patients with chronic idiopathic neck pain will be randomized to receive pain neuroscience education and shoulder/neck traditional exercises (n=33) or pain neuroscience education and shoulder/neck suspension exercises (n=33). Data on pain intensity (Visual Analogue Scale), pain disability, neck flexor and extensor muscles endurance, scapulae stabilizers endurance, pain catastrophizing (Pain catastrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and knowledge of pain neurophysiology (Neurophysiology of Pain Questionnaire) will be collected. Measurements will be taken before, after the intervention and at 3 months follow up.

Statistical analysis will be performed using a mixed-methods ANOVA.

Interventions

  • Other: Pain neuroscience education (PNE) and traditional exercise
    • PNE will cover the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. Exercise of the neck and scapular regions, including strength, motor control and stretching exercises. Initially (first 3 sessions) will be delivered individually and then (last 3 sessions)in small groups (4 participants). A total of 6 sessions will be delivered during 6 weeks. Each session will take around 1 hour.
  • Other: Pain neuroscience education (PNE) and suspension exercise
    • PNE will cover the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. Exercise of the neck and scapular regions, including strength, motor control and stretching exercises. delivered in suspension. Initially (first 3 sessions) will be delivered individually and then (last 3 sessions)in small groups (4 participants). A total of 6 sessions will be delivered during 6 weeks. Each session will take around 1 hour.

Arms, Groups and Cohorts

  • Experimental: Traditional exercise and pain neuroscience education
    • Will include exercises of the neck and scapular regions using traditional methods and pain neuroscience education
  • Active Comparator: Suspension exercise and pain neuroscience education
    • Will include suspension exercises of the neck and scapular regions using traditional methods and pain education.

Clinical Trial Outcome Measures

Primary Measures

  • Pain intensity: VAS
    • Time Frame: Baseline
    • Method of assessment – Visual analogue scale (VAS), which measures pain intensity from a minimum of 0 to a maximum of 10 (maximum pain intensity).
  • Pain intensity: VAS
    • Time Frame: 7 weeks
    • Method of assessment – Visual analogue scale (VAS), which measures pain intensity from a minimum of 0 to a maximum of 10 (maximum pain intensity).
  • Pain intensity: VAS
    • Time Frame: 6 months
    • Method of assessment – Visual analogue scale (VAS), which measures pain intensity from a minimum of 0 to a maximum of 10 (maximum pain intensity).
  • Neck pain associated disability
    • Time Frame: Baseline
    • Method of assessment – the Neck Disability Index, which is a disability index with 5 questions on neck pain associated disability that ranges from 0 (no disability) to 50 (complete disability).
  • Neck pain associated disability
    • Time Frame: 7 weeks
    • Method of assessment – the Neck Disability Index, which is a disability index with 5 questions on neck pain associated disability that ranges from 0 (no disability) to 50 (complete disability).
  • Neck pain associated disability
    • Time Frame: 6 months
    • Method of assessment – the Neck Disability Index, which is a disability index with 5 questions on neck pain associated disability that ranges from 0 (no disability) to 50 (complete disability).

Secondary Measures

  • Neck pain frequency
    • Time Frame: Baseline
    • Method of assessment – a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
  • Neck pain frequency
    • Time Frame: 7 weeks
    • Method of assessment – a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
  • Neck pain frequency
    • Time Frame: 6 months
    • Method of assessment – a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
  • Neck pain location
    • Time Frame: Baseline
    • Method of assessment – a body chart where the patients will draw where he/she feels pain
  • Neck pain location
    • Time Frame: 7 weeks
    • Method of assessment – a body chart where the patients will draw where he/she feels pain
  • Neck pain location
    • Time Frame: 6 months
    • Method of assessment – a body chart where the patients will draw where he/she feels pain
  • Neck flexor muscles endurance test
    • Time Frame: Baseline
    • 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 flexor muscles endurance test
    • Time Frame: 7 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 flexor muscles endurance test
    • Time Frame: 6 months
    • 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 extensor muscles endurance test
    • Time Frame: Baseline
    • 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 extensor muscles endurance test
    • Time Frame: 7 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.
  • Neck extensor muscles endurance test
    • Time Frame: 6 months
    • 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 test
    • Time Frame: Baseline
    • 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 test
    • Time Frame: 7 weeks
    • 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 test
    • Time Frame: 6 months
    • 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.
  • Pain Catastrophizing Scale
    • Time Frame: Baseline
    • Method of assessment – the Pain Catastrophizing Scale; score ranges from 0 (no catastrophizing) to 52 (maximum catastrophizing).
  • Pain Catastrophizing Scale
    • Time Frame: 7 weeks
    • Method of assessment – the Pain Catastrophizing Scale; score ranges from 0 (no catastrophizing) to 52 (maximum catastrophizing).
  • Pain Catastrophizing Scale
    • Time Frame: 6 months
    • Method of assessment – the Pain Catastrophizing Scale; score ranges from 0 (no catastrophizing) to 52 (maximum catastrophizing).
  • Neurophysiology of pain questionnaire
    • Time Frame: Baseline
    • Method of assessment – the Neurophysiology of pain questionnaire which measures the patients’ knowledge on pain neurophysiology; score ranges from 0 to 19 and the higher the score the more patients know on pain neurophysiology.
  • Neurophysiology of pain questionnaire
    • Time Frame: 7 weeks
    • Method of assessment – the Neurophysiology of pain questionnaire which measures the patients’ knowledge on pain neurophysiology; score ranges from 0 to 19 and the higher the score the more patients know on pain neurophysiology.
  • Neurophysiology of pain questionnaire
    • Time Frame: 6 months
    • Method of assessment – the Neurophysiology of pain questionnaire which measures the patients’ knowledge on pain neurophysiology; score ranges from 0 to 19 and the higher the score the more patients know on pain neurophysiology.
  • Patients’ Global Impression of Change
    • Time Frame: Baseline
    • Method of assessment – the Patients’ Global Impression of Change is a 7 point numeric rating scale; a score of 5 or more in the PGIC is associated with a clinically significant improvement in the patients’ condition.
  • Patients’ Global Impression of Change
    • Time Frame: 7 weeks
    • Method of assessment – the Patients’ Global Impression of Change is a 7 point numeric rating scale; a score of 5 or more in the PGIC is associated with a clinically significant improvement in the patients’ condition.
  • Patients’ Global Impression of Change
    • Time Frame: 6 months
    • Method of assessment – the Patients’ Global Impression of Change is a 7 point numeric rating scale; a score of 5 or more in the PGIC is associated with a clinically significant improvement in the patients’ condition.
  • TAMPA scale of kinesiophobia
    • Time Frame: Baseline
    • Method of assessment – the TAMPA scale of kinesiophobia assesses fear of movement and its score ranges from 13 to 52; the higher the score the higher the fear of movement.
  • TAMPA scale of kinesiophobia
    • Time Frame: 7 weeks
    • Method of assessment – the TAMPA scale of kinesiophobia assesses fear of movement and its score ranges from 13 to 52; the higher the score the higher the fear of movement.
  • TAMPA scale of kinesiophobia
    • Time Frame: 6 months
    • Method of assessment – the TAMPA scale of kinesiophobia assesses fear of movement and its score ranges from 13 to 52; the higher the score the higher the fear of movement.
  • Chronic Pain Coping Inventory
    • Time Frame: Baseline
    • Method of assessment – Chronic Pain Coping Inventory is a scale that assesses patient coping strategies; Patients are asked to rate the number of days (0-7 days) over the past week when they used each of 65 strategies at least once.
  • Chronic Pain Coping Inventory
    • Time Frame: 7 weeks
    • Method of assessment – Chronic Pain Coping Inventory is a scale that assesses patient coping strategies; Patients are asked to rate the number of days (0-7 days) over the past week when they used each of 65 strategies at least once.
  • Chronic Pain Coping Inventory
    • Time Frame: 6 months
    • Method of assessment – Chronic Pain Coping Inventory is a scale that assesses patient coping strategies; Patients are asked to rate the number of days (0-7 days) over the past week when they used each of 65 strategies at least once.

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of chronic idiopathic neck pain.

Exclusion Criteria

  • Cervical radiculopathy
  • Neck fractures
  • Tumors
  • Rheumatological disorders
  • Any other serious cause of neck pain

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aveiro University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anabela G Silva, Principal Investigator – Aveiro University
  • Overall Contact(s)
    • Anabela Silva, PhD, +351234247119, asilva@ua.pt

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