Neck PainNCT02827994
Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain
A study testing neurophysiology of pain education and exercises in people with Neck Pain, run by Aveiro University.
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). Read more about this study
- Who is it for?
- Ages 16 to 20 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- neurophysiology of pain education and exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jun 2015
- 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 16 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- No exclusion criteria
About this study
Official title: Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain: a School-based Pilot, Randomised and Controlled Study
This study compared the effectiveness of pain neurophysiology education and neck/shoulder exercises with no intervention in adolescents with chronic idiopathic neck pain (CINP).
Read the detailed 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.
- Conditions
- Neck Pain
- Being tested
- neurophysiology of pain education and exercises
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurophysiology of pain education and exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Education and exercise | Experimental | The intervention included neurophysiology of pain education and exercises. Receives: Other: neurophysiology of pain education and exercises |
| No intervention | No intervention | This group received no intervention as participants were students that were not seeking treatment for their pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Method of assessment - Visual analogue scale
Measured: At the beginning
Pain intensity
Method of assessment - Visual analogue scale
Measured: 5 weeks
Secondary outcomes (19)
Neck pain frequency
Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
Measured: At the beginning
Neck pain frequency
Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)
Measured: 5 weeks
Neck pain duration
Method of assessment - a question on neck pain duration (how long have you have neck pain?)
Measured: At the beginning
Neck pain duration
Method of assessment - a question on neck pain duration (how long have you have neck pain?)
Measured: 5 weeks
Neck pain associated disability
Method of assessment - a disability index with 5 questions on neck pain associated disability
Measured: At the beginning
Neck pain associated disability
Method of assessment - a disability index with 5 questions on neck pain associated disability
Measured: 5 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: At the beginning
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: 5 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: At the beginning
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: 5 weeks
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.
Measured: At the beginning
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.
Measured: 5 weeks
State-trait anxiety inventory
Method of assessment - scale
Measured: At the beginning
State-trait anxiety inventory
Method of assessment - scale
Measured: 5 weeks
Pain Catastrophizing Scale
Method of assessment - scale
Measured: At the beginning
Pain Catastrophizing Scale
Method of assessment - scale
Measured: 5 weeks
Neurophysiology of pain questionnaire
Method of assessment - questionnaire
Measured: At the beginning
Neurophysiology of pain questionnaire
Method of assessment - questionnaire
Measured: 5 weeks
Patients' Global Impression of Change
Method of assessment - scale
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJun 2015
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
- None (open label)
- Enrolment
- 43 participants (actual)
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
- NCT02827994
- Sponsor's protocol ID
- PCEDCSS_FMUP 5/2015
- Status last verified
- Jul 2016
- First submitted
- 23 Jun 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain: a School-based Pilot, Randomised and Controlled Study
- ClinicalTrials.gov ID
- NCT02827994
- Acronym / sponsor ID
- PCEDCSS_FMUP 5/2015
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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 compared the effectiveness of pain neurophysiology education and neck/shoulder exercises with no intervention in adolescents with chronic idiopathic neck pain (CINP).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education and exercise | Experimental | Other: neurophysiology of pain education and exercisesThe intervention included neurophysiology of pain education and exercises. |
| No intervention | No intervention | –This group received no intervention as participants were students that were not seeking treatment for their pain. |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| neurophysiology of pain education and exercisesPain 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. | Other | Education and exercise |
Primary outcome
Pain intensity
Time frame: At the beginning
Method of assessment - Visual analogue scale
Pain intensity
Time frame: 5 weeks
Method of assessment - Visual analogue scale
19 secondary outcomes
Neck pain frequency
Time frame: At the beginning
Neck pain frequency
Time frame: 5 weeks
Neck pain duration
Time frame: At the beginning
Neck pain duration
Time frame: 5 weeks
Neck pain associated disability
Time frame: At the beginning
Neck pain associated disability
Time frame: 5 weeks
Neck flexor muscles endurance test
Time frame: At the beginning
Neck flexor muscles endurance test
Time frame: 5 weeks
Neck extensor muscles endurance test
Time frame: At the beginning
Neck extensor muscles endurance test
Time frame: 5 weeks
Scapular stabilizers' endurance test
Time frame: At the beginning
Scapular stabilizers' endurance test
Time frame: 5 weeks
State-trait anxiety inventory
Time frame: At the beginning
State-trait anxiety inventory
Time frame: 5 weeks
Pain Catastrophizing Scale
Time frame: At the beginning
Pain Catastrophizing Scale
Time frame: 5 weeks
Neurophysiology of pain questionnaire
Time frame: At the beginning
Neurophysiology of pain questionnaire
Time frame: 5 weeks
Patients' Global Impression of Change
Time frame: 5 weeks
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 11 Jul 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing neurophysiology of pain education and exercises 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 11 Jul 2016. 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 2 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 11 Jul 2016.