Neck PainNCT03667209
Exercise and Pain Neuroscience Education for Patients With Neck Pain: Impact on Pain and Disability
A study testing Pain neuroscience education (PNE) and traditional exercise and Pain neuroscience education (PNE) and suspension exercise in people with Neck Pain, run by Aveiro University at 1 site in Portugal.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain
- What is being tested?
- Pain neuroscience education (PNE) and traditional exercise and Pain neuroscience education (PNE) and suspension exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Nov 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic idiopathic neck pain.
Who cannot join
- Cervical radiculopathy
- Neck fractures
- Tumors
- Rheumatological disorders
- Any other serious cause of neck pain
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Escola Superior de Saúde
Aveiro
Anabela Silva, PhD
About this study
Official title: 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).
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Pain neuroscience education (PNE) and traditional exercise, Pain neuroscience education (PNE) and suspension exercise
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuroscience education (PNE) and traditional exerciseOther
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 exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional exercise and pain neuroscience education | Experimental | Will include exercises of the neck and scapular regions using traditional methods and pain neuroscience education Receives: Other: Pain neuroscience education (PNE) and traditional exercise |
| Suspension exercise and pain neuroscience education | Active comparator | Will include suspension exercises of the neck and scapular regions using traditional methods and pain education. Receives: Other: Pain neuroscience education (PNE) and suspension exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 months
Secondary outcomes (30)
Neck pain frequency
Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
Measured: Baseline
Neck pain frequency
Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
Measured: 7 weeks
Neck pain frequency
Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
Measured: 6 months
Neck pain location
Method of assessment - a body chart where the patients will draw where he/she feels pain
Measured: Baseline
Neck pain location
Method of assessment - a body chart where the patients will draw where he/she feels pain
Measured: 7 weeks
Neck pain location
Method of assessment - a body chart where the patients will draw where he/she feels pain
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Pain Catastrophizing Scale
Method of assessment - the Pain Catastrophizing Scale; score ranges from 0 (no catastrophizing) to 52 (maximum catastrophizing).
Measured: Baseline
Pain Catastrophizing Scale
Method of assessment - the Pain Catastrophizing Scale; score ranges from 0 (no catastrophizing) to 52 (maximum catastrophizing).
Measured: 7 weeks
Pain Catastrophizing Scale
Method of assessment - the Pain Catastrophizing Scale; score ranges from 0 (no catastrophizing) to 52 (maximum catastrophizing).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Nov 2018
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anabela G Silva, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667209
- Sponsor's protocol ID
- 21/2018
- Status last verified
- Oct 2018
- First submitted
- 10 Sep 2018
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Pain Neuroscience Education for Patients With Neck Pain: Impact
- ClinicalTrials.gov ID
- NCT03667209
- Acronym / sponsor ID
- 21/2018
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional exercise and pain neuroscience education | Experimental | Other: Pain neuroscience education (PNE) and traditional exerciseWill include exercises of the neck and scapular regions using traditional methods and pain neuroscience education |
| Suspension exercise and pain neuroscience education | Active comparator | Other: Pain neuroscience education (PNE) and suspension exerciseWill include suspension exercises of the neck and scapular regions using traditional methods and pain education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of chronic idiopathic neck pain.
Key exclusion criteria (5 listed)
- Cervical radiculopathy
- Neck fractures
- Tumors
- Rheumatological disorders
- Any other serious cause of neck pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain neuroscience education (PNE) and traditional exercisePNE 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. | Other | Traditional exercise and pain neuroscience education |
| Pain neuroscience education (PNE) and suspension exercisePNE 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. | Other | Suspension exercise and pain neuroscience education |
Primary outcome
Pain intensity: VAS
Time frame: Baseline
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
Time frame: 7 weeks
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
Time frame: 6 months
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
Time frame: Baseline
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
Time frame: 7 weeks
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
Time frame: 6 months
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).
30 secondary outcomes
Neck pain frequency
Time frame: Baseline
Neck pain frequency
Time frame: 7 weeks
Neck pain frequency
Time frame: 6 months
Neck pain location
Time frame: Baseline
Neck pain location
Time frame: 7 weeks
Neck pain location
Time frame: 6 months
Neck flexor muscles endurance test
Time frame: Baseline
Neck flexor muscles endurance test
Time frame: 7 weeks
Neck flexor muscles endurance test
Time frame: 6 months
Neck extensor muscles endurance test
Time frame: Baseline
Neck extensor muscles endurance test
Time frame: 7 weeks
Neck extensor muscles endurance test
Time frame: 6 months
Scapular stabilizers' endurance test
Time frame: Baseline
Scapular stabilizers' endurance test
Time frame: 7 weeks
Scapular stabilizers' endurance test
Time frame: 6 months
Pain Catastrophizing Scale
Time frame: Baseline
Pain Catastrophizing Scale
Time frame: 7 weeks
Pain Catastrophizing Scale
Time frame: 6 months
Neurophysiology of pain questionnaire
Time frame: Baseline
Neurophysiology of pain questionnaire
Time frame: 7 weeks
Neurophysiology of pain questionnaire
Time frame: 6 months
Patients' Global Impression of Change
Time frame: Baseline
Patients' Global Impression of Change
Time frame: 7 weeks
Patients' Global Impression of Change
Time frame: 6 months
TAMPA scale of kinesiophobia
Time frame: Baseline
TAMPA scale of kinesiophobia
Time frame: 7 weeks
TAMPA scale of kinesiophobia
Time frame: 6 months
Chronic Pain Coping Inventory
Time frame: Baseline
Chronic Pain Coping Inventory
Time frame: 7 weeks
Chronic Pain Coping Inventory
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain neuroscience education (PNE) and traditional exercise and Pain neuroscience education (PNE) and suspension exercise in people with Neck Pain, run by Aveiro University at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anabela Silva, PhD (+351234247119 ext. +351234247119, asilva@ua.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity: VAS (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.