Exercise and Pain Neuroscience Education for Patients With Neck Pain: Impact on Pain and Disability
1 other identifier
interventional
66
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMay 9, 2019
October 1, 2018
1.8 years
September 10, 2018
May 8, 2019
Conditions
Outcome Measures
Primary Outcomes (6)
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 Outcomes (30)
Neck pain frequency
Baseline
Neck pain frequency
7 weeks
Neck pain frequency
6 months
Neck pain location
Baseline
Neck pain location
7 weeks
- +25 more secondary outcomes
Study Arms (2)
Traditional exercise and pain neuroscience education
EXPERIMENTALWill include exercises of the neck and scapular regions using traditional methods and pain neuroscience education
Suspension exercise and pain neuroscience education
ACTIVE COMPARATORWill include suspension exercises of the neck and scapular regions using traditional methods and pain education.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of chronic idiopathic neck pain.
You may not qualify if:
- Cervical radiculopathy
- Neck fractures
- Tumors
- Rheumatological disorders
- Any other serious cause of neck pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Escola Superior de Saúde
Aveiro, Portugal
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 10, 2018
First Posted
September 12, 2018
Study Start
November 1, 2018
Primary Completion
September 1, 2020
Study Completion
December 1, 2020
Last Updated
May 9, 2019
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share