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

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

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).

Study Overview

• Status: Unknown
• Conditions: Neck Pain
• Intervention / Treatment: Other: Pain neuroscience education (PNE) and traditional exercise; Other: Pain neuroscience education (PNE) and suspension exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Aveiro, Portugal
    • Recruiting
    • Escola Superior de Saúde
    • Contact: Anabela Silva, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traditional exercise and pain neuroscience education; Will include exercises of the neck and scapular regions using traditional methods and pain neuroscience education	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.
Active Comparator: Suspension exercise and pain neuroscience education; Will include suspension exercises of the neck and scapular regions using traditional methods and pain education.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline
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).	7 weeks
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).	6 months
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).	Baseline
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).	7 weeks
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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck pain frequency	Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)	Baseline
Neck pain frequency	Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)	7 weeks
Neck pain frequency	Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)	6 months
Neck pain location	Method of assessment - a body chart where the patients will draw where he/she feels pain	Baseline
Neck pain location	Method of assessment - a body chart where the patients will draw where he/she feels pain	7 weeks
Neck pain location	Method of assessment - a body chart where the patients will draw where he/she feels pain	6 months
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.	Baseline
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.	7 weeks
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.	6 months
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.	Baseline
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.	7 weeks
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.	6 months
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.	Baseline
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.	7 weeks
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.	6 months
Pain Catastrophizing Scale	Method of assessment - the Pain Catastrophizing Scale; score ranges from 0 (no catastrophizing) to 52 (maximum catastrophizing).	Baseline
Pain Catastrophizing Scale	Method of assessment - the Pain Catastrophizing Scale; score ranges from 0 (no catastrophizing) to 52 (maximum catastrophizing).	7 weeks
Pain Catastrophizing Scale	Method of assessment - the Pain Catastrophizing Scale; score ranges from 0 (no catastrophizing) to 52 (maximum catastrophizing).	6 months
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.	Baseline
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.	7 weeks
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.	6 months
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.	Baseline
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.	7 weeks
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.	6 months
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.	Baseline
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.	7 weeks
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.	6 months
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.	Baseline
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.	7 weeks
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.	6 months

Collaborators and Investigators

• Sponsor: Aveiro University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 21/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No