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

Primary Purpose

Neck Pain

Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Pain neuroscience education (PNE) and traditional exercise
Pain neuroscience education (PNE) and suspension exercise
Sponsored by
Aveiro University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Escola Superior de SaúdeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Traditional exercise and pain neuroscience education

Suspension exercise and pain neuroscience education

Arm Description

Will include exercises of the neck and scapular regions using traditional methods and pain neuroscience education

Will include suspension exercises of the neck and scapular regions using traditional methods and pain education.

Outcomes

Primary Outcome Measures

Pain intensity: VAS
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
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
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
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
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
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 Outcome Measures

Neck pain frequency
Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
Neck pain frequency
Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
Neck pain frequency
Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
Neck pain location
Method of assessment - a body chart where the patients will draw where he/she feels pain
Neck pain location
Method of assessment - a body chart where the patients will draw where he/she feels pain
Neck pain location
Method of assessment - a body chart where the patients will draw where he/she feels pain
Neck flexor muscles endurance test
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
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
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
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
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
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
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
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
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
Method of assessment - the Pain Catastrophizing Scale; score ranges from 0 (no catastrophizing) to 52 (maximum catastrophizing).
Pain Catastrophizing Scale
Method of assessment - the Pain Catastrophizing Scale; score ranges from 0 (no catastrophizing) to 52 (maximum catastrophizing).
Pain Catastrophizing Scale
Method of assessment - the Pain Catastrophizing Scale; score ranges from 0 (no catastrophizing) to 52 (maximum catastrophizing).
Neurophysiology of pain questionnaire
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
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
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
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
September 10, 2018
Last Updated
May 8, 2019
Sponsor
Aveiro University
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1. Study Identification

Unique Protocol Identification Number
NCT03667209
Brief Title
Exercise and Pain Neuroscience Education for Patients With Neck Pain: Impact on Pain and Disability
Official Title
Exercise and Pain Neuroscience Education for Patients With Neck Pain: Impact
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aveiro University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional exercise and pain neuroscience education
Arm Type
Experimental
Arm Description
Will include exercises of the neck and scapular regions using traditional methods and pain neuroscience education
Arm Title
Suspension exercise and pain neuroscience education
Arm Type
Active Comparator
Arm Description
Will include suspension exercises of the neck and scapular regions using traditional methods and pain education.
Intervention Type
Other
Intervention Name(s)
Pain neuroscience education (PNE) and traditional exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pain neuroscience education (PNE) and suspension exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity: VAS
Description
Method of assessment - Visual analogue scale (VAS), which measures pain intensity from a minimum of 0 to a maximum of 10 (maximum pain intensity).
Time Frame
Baseline
Title
Pain intensity: VAS
Description
Method of assessment - Visual analogue scale (VAS), which measures pain intensity from a minimum of 0 to a maximum of 10 (maximum pain intensity).
Time Frame
7 weeks
Title
Pain intensity: VAS
Description
Method of assessment - Visual analogue scale (VAS), which measures pain intensity from a minimum of 0 to a maximum of 10 (maximum pain intensity).
Time Frame
6 months
Title
Neck pain associated disability
Description
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).
Time Frame
Baseline
Title
Neck pain associated disability
Description
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).
Time Frame
7 weeks
Title
Neck pain associated disability
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Neck pain frequency
Description
Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
Time Frame
Baseline
Title
Neck pain frequency
Description
Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
Time Frame
7 weeks
Title
Neck pain frequency
Description
Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
Time Frame
6 months
Title
Neck pain location
Description
Method of assessment - a body chart where the patients will draw where he/she feels pain
Time Frame
Baseline
Title
Neck pain location
Description
Method of assessment - a body chart where the patients will draw where he/she feels pain
Time Frame
7 weeks
Title
Neck pain location
Description
Method of assessment - a body chart where the patients will draw where he/she feels pain
Time Frame
6 months
Title
Neck flexor muscles endurance test
Description
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.
Time Frame
Baseline
Title
Neck flexor muscles endurance test
Description
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.
Time Frame
7 weeks
Title
Neck flexor muscles endurance test
Description
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.
Time Frame
6 months
Title
Neck extensor muscles endurance test
Description
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.
Time Frame
Baseline
Title
Neck extensor muscles endurance test
Description
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.
Time Frame
7 weeks
Title
Neck extensor muscles endurance test
Description
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.
Time Frame
6 months
Title
Scapular stabilizers' endurance test
Description
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.
Time Frame
Baseline
Title
Scapular stabilizers' endurance test
Description
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.
Time Frame
7 weeks
Title
Scapular stabilizers' endurance test
Description
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.
Time Frame
6 months
Title
Pain Catastrophizing Scale
Description
Method of assessment - the Pain Catastrophizing Scale; score ranges from 0 (no catastrophizing) to 52 (maximum catastrophizing).
Time Frame
Baseline
Title
Pain Catastrophizing Scale
Description
Method of assessment - the Pain Catastrophizing Scale; score ranges from 0 (no catastrophizing) to 52 (maximum catastrophizing).
Time Frame
7 weeks
Title
Pain Catastrophizing Scale
Description
Method of assessment - the Pain Catastrophizing Scale; score ranges from 0 (no catastrophizing) to 52 (maximum catastrophizing).
Time Frame
6 months
Title
Neurophysiology of pain questionnaire
Description
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.
Time Frame
Baseline
Title
Neurophysiology of pain questionnaire
Description
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.
Time Frame
7 weeks
Title
Neurophysiology of pain questionnaire
Description
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.
Time Frame
6 months
Title
Patients' Global Impression of Change
Description
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.
Time Frame
Baseline
Title
Patients' Global Impression of Change
Description
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.
Time Frame
7 weeks
Title
Patients' Global Impression of Change
Description
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.
Time Frame
6 months
Title
TAMPA scale of kinesiophobia
Description
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.
Time Frame
Baseline
Title
TAMPA scale of kinesiophobia
Description
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.
Time Frame
7 weeks
Title
TAMPA scale of kinesiophobia
Description
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.
Time Frame
6 months
Title
Chronic Pain Coping Inventory
Description
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.
Time Frame
Baseline
Title
Chronic Pain Coping Inventory
Description
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.
Time Frame
7 weeks
Title
Chronic Pain Coping Inventory
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anabela Silva, PhD
Phone
+351234247119
Ext
+351234247119
Email
asilva@ua.pt
Facility Information:
Facility Name
Escola Superior de Saúde
City
Aveiro
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anabela Silva, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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