Neck PainNCT01778036
Neck Motion and Motor Control in Chronic Neck Pain and Associations With Clinical Symptoms
An observational study of Neck Pain, run by Norwegian University of Science and Technology at 2 sites in Norway.
Trial summary
The primary purpose of this study is to investigate if there is altered motor control of head and neck in chronic neck pain patients compared with healthy persons. In addition, associations between neck pain, motor control, disability and function, and clinical symptoms will be studied in patients following… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Neck Pain
- How many people
- 84 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2013to Aug 2014
- Phase
- Observational
- 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 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Neck pain patients referred to physiotherapy treatment in primary health care
Who may be able to join
- Idiopathic neck pain with duration >2 weeks
- Normal or corrected vision
- Pain at or above 3 on Numeric Rating Scale, with "low pain" defined as 3-4 and "high pain" as 5 or higher.
Who cannot join
- Systemic or diagnosed chronic disease, including diabetes, stroke and neurological diseases, that may influence motor control and neck pain or ability to perform tests
- positive spurling test for neurological radiating arm pain
- pregnancy
- whiplash
- insufficient comprehension of Norwegian language
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
University of Oslo
Oslo
Norwegian University of Science and Technology
Trondheim
About this study
The primary purpose of this study is to investigate if there is altered motor control of head and neck in chronic neck pain patients compared with healthy persons. In addition, associations between neck pain, motor control, disability and function, and clinical symptoms will be studied in patients following physiotherapy treatment in primary health care.
- Conditions
- Neck Pain
- Keywords
- Neck movement, motor control, disability, psychological variables, Head Movements, Physical therapy, Fear avoidance, Self Efficacy, Catastrophizing, Fly test, Postural sway
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neck pain patients following physiotherapy treatment | Neck pain patients will follow physiotherapy treatment in primary health care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conjunct motion
Describes the movement stiffness in active movements of the neck. Conjunct motion is movement in the two associated movement planes to the primary plane. For example,the amount of rotation and lateral flexion during neck flexion and extension. Measured by 3D Liberty device and with degrees as unit of measure.
Measured: up to 8 weeks
Secondary outcomes (6)
head motion smoothness
Measured by a 3D Liberty device and with velocity(degrees/s)as unit of measure
Measured: up to 8 weeks
reposition accuracy
Measured by 3D Liberty device and with degrees as unit of measure
Measured: up to 8 weeks
postural sway.
Measured by 3D Liberty device and trunk sway as a unit of measure
Measured: up to 8 weeks
Head stabilization
Measured by 3D Liberty device and with velocity (degrees/second) as unit of measure
Measured: up to 8 weeks
pain
a numerical pain rating scale will be used to measure neck pain.
Measured: up to 24 weeks
Head motion accuracy
Head motion accuracy will be measured by a 3D Liberty device and centimeter will be used as a unit of measure
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
- Investigators
- Ottar Vasseljen, prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778036
- Sponsor's protocol ID
- 2011/2522
- Status last verified
- Mar 2017
- First submitted
- 25 Jan 2013
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meisingset I, Stensdotter AK, Woodhouse A, Vasseljen O. Neck motion, motor control, pain and disability: A longitudinal study of associations in neck pain patients in physiotherapy treatment. Man Ther. 2016 Apr;22:94-100. doi: 10.1016/j.math.2015.10.013. Epub 2015 Nov 2.
PubMed 26586133
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neck Motion and Motor Control in Chronic Neck Pain and Associations With Clinical Symptoms
- ClinicalTrials.gov ID
- NCT01778036
- Acronym / sponsor ID
- 2011/2522
- Conditions
- Neck Pain
- Keywords
- Neck movement, motor control, disability, psychological variables, Head Movements, Physical therapy, Fear avoidance, Self Efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Jan 2013 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 29 Jan 2013 (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.
The primary purpose of this study is to investigate if there is altered motor control of head and neck in chronic neck pain patients compared with healthy persons. In addition, associations between neck pain, motor control, disability and function, and clinical symptoms will be studied in patients following physiotherapy treatment in primary health care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neck pain patients following physiotherapy treatment | – | –Neck pain patients will follow physiotherapy treatment in primary health care. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neck pain patients referred to physiotherapy treatment in primary health care
Key inclusion criteria (3 listed)
- Idiopathic neck pain with duration >2 weeks
- Normal or corrected vision
- Pain at or above 3 on Numeric Rating Scale, with "low pain" defined as 3-4 and "high pain" as 5 or higher.
Key exclusion criteria (5 listed)
- Systemic or diagnosed chronic disease, including diabetes, stroke and neurological diseases, that may influence motor control and neck pain or ability to perform tests
- positive spurling test for neurological radiating arm pain
- pregnancy
- whiplash
- insufficient comprehension of Norwegian language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Conjunct motion
Time frame: up to 8 weeks
Describes the movement stiffness in active movements of the neck. Conjunct motion is movement in the two associated movement planes to the primary plane. For example,the amount of rotation and lateral flexion during neck flexion and extension. Measured by 3D Liberty device and with degrees as unit of measure.
6 secondary outcomes
head motion smoothness
Time frame: up to 8 weeks
reposition accuracy
Time frame: up to 8 weeks
postural sway.
Time frame: up to 8 weeks
Head stabilization
Time frame: up to 8 weeks
pain
Time frame: up to 24 weeks
Head motion accuracy
Time frame: up to 8 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 27 Mar 2017.
- Results publication: PubMed 26586133Meisingset I, Stensdotter AK, Woodhouse A, Vasseljen O. Neck motion, motor control, pain and disability: A longitudinal study of associations in neck pain patients in physiotherapy treatment. Man Ther. 2016 Apr;22:94-100. doi: 10.1016/j.math.2015.10.013. Epub 2015 Nov 2.
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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.
Ottar Vasseljen, prof study director
Norwegian University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain, run by Norwegian University of Science and Technology at 2 sites in Norway.
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 3 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: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
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?
Conjunct motion (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01778036, which also lists 1 linked publication.
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 27 Mar 2017.