Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain

Neck Pain Clinical Trial

Official title:

Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain: a School-based Pilot, Randomised and Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827994
• Other study ID #: PCEDCSS_FMUP 5/2015
• Status: Completed
• Phase: N/A
• First received: June 23, 2016
• Last updated: July 6, 2016
• Start date: March 2015
• Est. completion date: June 2015

Study information

• Verified date: July 2016
• Source: Aveiro University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Health Ethic Committee
• Study type: Interventional

Clinical Trial Summary

This study compared the effectiveness of pain neurophysiology education and neck/shoulder exercises with no intervention in adolescents with chronic idiopathic neck pain (CINP).

Description:

Forty three adolescents with chronic idiopathic neck pain were randomly allocated to receive pain neurophysiology education and shoulder/neck exercises (n=21) or no intervention (n=22). 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) were collected. Measurements were taken before and after the intervention.

Statistical analysis were performed using a mixed-methods ANOVA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 20 Years

Eligibility

Inclusion Criteria:

• To be invited to enter the study participants had to have chronic idiopathic neck/shoulder pain, defined as pain felt in the neck/shoulder regions at least once a week in the previous 3 months.

Exclusion Criteria:

• No exclusion criteria

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• neurophysiology of pain education and exercises
Pain neurophysiology education covered the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. It was delivered in small groups (4 to 7 participants). A total of 4 sessions were delivered over 4 weeks (1 session per week). Each session took between 45 minutes and 1 hour. Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular muscles delivered over 3 sessions (the first session covered pain neurophysiology education only). Each exercise was performed in 3 series of 10 repetitions. The number of exercises targeting the same group of muscles increased from one in the 2nd session to 2/3 in the 4th session.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aveiro University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Method of assessment - Visual analogue scale	At the beginning	No
Primary	Pain intensity	Method of assessment - Visual analogue scale	5 weeks	No
Secondary	Neck pain frequency	Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)	At the beginning	No
Secondary	Neck pain frequency	Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)	5 weeks	No
Secondary	Neck pain duration	Method of assessment - a question on neck pain duration (how long have you have neck pain?)	At the beginning	No
Secondary	Neck pain duration	Method of assessment - a question on neck pain duration (how long have you have neck pain?)	5 weeks	No
Secondary	Neck pain associated disability	Method of assessment - a disability index with 5 questions on neck pain associated disability	At the beginning	No
Secondary	Neck pain associated disability	Method of assessment - a disability index with 5 questions on neck pain associated disability	5 weeks	No
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.	At the beginning	No
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.	5 weeks	No
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.	At the beginning	No
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.	5 weeks	No
Secondary	Scapular stabilizers' endurance test	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.	At the beginning	No
Secondary	Scapular stabilizers' endurance test	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.	5 weeks	No
Secondary	State-trait anxiety inventory	Method of assessment - scale	At the beginning	No
Secondary	State-trait anxiety inventory	Method of assessment - scale	5 weeks	No
Secondary	Pain Catastrophizing Scale	Method of assessment - scale	At the beginning	No
Secondary	Pain Catastrophizing Scale	Method of assessment - scale	5 weeks	No
Secondary	Neurophysiology of pain questionnaire	Method of assessment - questionnaire	At the beginning	No
Secondary	Neurophysiology of pain questionnaire	Method of assessment - questionnaire	5 weeks	No
Secondary	Patients' Global Impression of Change	Method of assessment - scale	5 weeks	No