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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03667209
• Other study ID #: 21/2018
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 2020

Study information

• Verified date: October 2018
• Source: Aveiro University
• Contact: Anabela Silva, PhD
• Phone: +351234247119
• Email: asilva[@]ua.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Portugal	Escola Superior de Saúde	Aveiro

Sponsors (1)

Lead Sponsor	Collaborator
Aveiro University

Country where clinical trial is conducted

Portugal, 

Outcome

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