Neck PainNCT03362333
Pain Neuroscience Education and Exercise
A study testing Exercise and Pain neuroscience education in people with Neck Pain, run by Aveiro University.
Trial summary
This study examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain. 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?
- Exercise and Pain neuroscience education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 30 Oct 2016
- 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
- Participants could enter the study if they had chronic idiopathic neck pain, defined as pain felt in the neck at least once a week in the previous 3 months and for which no cause had been established. Furthermore, they were required to have a minimum pain intensity in the previous week of 2 in the visual analogue scale.
Who cannot join
- Participants were excluded if they had had physiotherapy for their neck pain in the 6 months previous to the study, if they had rheumatic, nervous, cardiac and/or respiratory pathology that could prevent or make it difficult to do the exercises. Exclusion criteria were ascertained by self-report.
About this study
Official title: Pain Neuroscience Education and Exercise Versus Exercise for University Students With Chronic Idiopathic Neck Pain: a Randomized, Controlled and Single Blind Study
This study examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain.
Read the detailed description
This study examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain.
University students with chronic neck pain were randomly allocated to receive pain neuroscience education and exercise or exercise only and assessed at baseline, after the intervention and at 3 months follow up. Outcome variables were pain intensity (primary outcome), disability, fear of movement, catastrophizing, knowledge of pain neurophysiology, pressure pain thresholds and neck and scapular muscle endurance.
- Conditions
- Neck Pain
- Being tested
- Exercise, Pain neuroscience education
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular stabilizer muscles.
Pain neuroscience educationOther
Pain neuroscience education covered the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience.
| Study group | Role | What they receive |
|---|---|---|
| pain neuroscience education and exercise | Experimental | This group received pain neuroscience education and exercise once a week over 4 weeks Receives: Other: Exercise; Other: Pain neuroscience education |
| Exercise | Active comparator | This group received exercise directed at the neck and shoulder regions once a week over 4 weeks Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Measured using the visual analogue scale
Measured: At the beginning
Pain intensity
Measured using the visual analogue scale
Measured: 5 weeks
Pain intensity
Measured using the visual analogue scale
Measured: At 3 months
Secondary outcomes (20)
Deep neck flexor endurance
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: At the beginning
Deep neck flexor endurance
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: 5 weeks
Neck extensors endurance
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: At the beginning
Neck extensors endurance
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: 5 weeks
Scapular stabilizers endurance
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.
Measured: At the beginning
Scapular stabilizers endurance
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.
Measured: 5 weeks
Pressure pain thresholds
Method of assessment - psychophysical test; Pressure was applied over the trapezius and at C5-C6 with a algometer until the participant first felt pain. The results was the quantity of force (in Kgf) supported by participants.
Measured: At the beginning
Pressure pain thresholds
Method of assessment - psychophysical test; Pressure was applied over the trapezius and at C5-C6 with a algometer until the participant first felt pain. The results was the quantity of force (in Kgf) supported by participants.
Measured: 5 weeks
Disability
Method of assessment - the neck pain disability index
Measured: At the beginning
Disability
Method of assessment - the neck pain disability index
Measured: 5 weeks
Disability
Method of assessment - the neck pain disability index
Measured: 3 months
catastrophizing
Method of assessment - Pain catastrophising scale
Measured: at beginning
catastrophizing
Method of assessment - Pain catastrophising scale
Measured: 5 weeks
catastrophizing
Method of assessment - Pain catastrophising scale
Measured: 3 months
fear of movement
method of assessment - the Tampa Scale
Measured: At the beginning
fear of movement
method of assessment - the Tampa Scale
Measured: 5 weeks
fear of movement
method of assessment - the Tampa Scale
Measured: 3 months
Knowledge of pain neurophysiology
method of assessment - scale; the neurophysiology of pain questionnaire
Measured: at beginning
Knowledge of pain neurophysiology
method of assessment - scale; the neurophysiology of pain questionnaire
Measured: 5 weeks
Knowledge of pain neurophysiology
method of assessment - scale; the neurophysiology of pain questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Oct 2015
- Primary completion28 Feb 2016
- Study completion30 Oct 2016
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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anabela G Silva, Aveiro University
- Investigators
- Anabela Silva, PhD, Principal investigator, University of Aveiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362333
- Sponsor's protocol ID
- PCEDCSS-FMUP 18
- Status last verified
- Dec 2017
- First submitted
- 28 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- 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 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neuroscience Education and Exercise Versus Exercise for University Students With Chronic Idiopathic Neck Pain: a Randomized, Controlled and Single Blind Study
- ClinicalTrials.gov ID
- NCT03362333
- Acronym / sponsor ID
- PCEDCSS-FMUP 18
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 28 Feb 2016 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 5 Dec 2017 (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 examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain.
Detailed description
This study examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain.
University students with chronic neck pain were randomly allocated to receive pain neuroscience education and exercise or exercise only and assessed at baseline, after the intervention and at 3 months follow up. Outcome variables were pain intensity (primary outcome), disability, fear of movement, catastrophizing, knowledge of pain neurophysiology, pressure pain thresholds and neck and scapular muscle endurance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pain neuroscience education and exercise | Experimental | Other: Exercise, Other: Pain neuroscience educationThis group received pain neuroscience education and exercise once a week over 4 weeks |
| Exercise | Active comparator | Other: ExerciseThis group received exercise directed at the neck and shoulder regions once a week over 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants could enter the study if they had chronic idiopathic neck pain, defined as pain felt in the neck at least once a week in the previous 3 months and for which no cause had been established. Furthermore, they were required to have a minimum pain intensity in the previous week of 2 in the visual analogue scale.
Key exclusion criteria (1 listed)
- Participants were excluded if they had had physiotherapy for their neck pain in the 6 months previous to the study, if they had rheumatic, nervous, cardiac and/or respiratory pathology that could prevent or make it difficult to do the exercises. Exclusion criteria were ascertained by self-report.
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 |
|---|---|---|
| ExerciseExercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular stabilizer muscles. | Other | Exercise, pain neuroscience education and exercise |
| Pain neuroscience educationPain neuroscience education covered the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. | Other | pain neuroscience education and exercise |
Primary outcome
Pain intensity
Time frame: At the beginning
Measured using the visual analogue scale
Pain intensity
Time frame: 5 weeks
Measured using the visual analogue scale
Pain intensity
Time frame: At 3 months
Measured using the visual analogue scale
20 secondary outcomes
Deep neck flexor endurance
Time frame: At the beginning
Deep neck flexor endurance
Time frame: 5 weeks
Neck extensors endurance
Time frame: At the beginning
Neck extensors endurance
Time frame: 5 weeks
Scapular stabilizers endurance
Time frame: At the beginning
Scapular stabilizers endurance
Time frame: 5 weeks
Pressure pain thresholds
Time frame: At the beginning
Pressure pain thresholds
Time frame: 5 weeks
Disability
Time frame: At the beginning
Disability
Time frame: 5 weeks
Disability
Time frame: 3 months
catastrophizing
Time frame: at beginning
catastrophizing
Time frame: 5 weeks
catastrophizing
Time frame: 3 months
fear of movement
Time frame: At the beginning
fear of movement
Time frame: 5 weeks
fear of movement
Time frame: 3 months
Knowledge of pain neurophysiology
Time frame: at beginning
Knowledge of pain neurophysiology
Time frame: 5 weeks
Knowledge of pain neurophysiology
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- 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.
Anabela Silva, PhD principal investigator
University of Aveiro
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Pain neuroscience education in people with Neck Pain, run by Aveiro University.
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 1 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: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: At the beginning). The study lists 3 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 5 Dec 2017.