Neck PainNCT02754934
Development of a Self-administered Neck Mobility Assessment Tool in Chronic Neck Pain Patients.
An observational study of Neck Pain, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
This study evaluates, if the movement of the cervical spine, assessed via a specific questionnaire by the patient, is a valid and reliable tool and could be used in daily clinical routine. 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?
- Cervical range of motion
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to Nov 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Investigators will include 50 participants with chronic neck pain
Who may be able to join
- Neck pain > 90 days
- Able to speak, read and write German
Who cannot join
- Red Flags e.g. Fracture of the cervical spine
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
About this study
This study evaluates, if the movement of the cervical spine, assessed via a specific questionnaire by the patient, is a valid and reliable tool and could be used in daily clinical routine.
Read the detailed description
Cervical range of motion is a frequently used assessment methods in patients with neck pain.
Although it seems to be used frequently, clinicians still prefer hands-on assessment. Furthermore it is interesting, if cervical range of motion,self-assessed by the patient is a valid and reliable tool.
- Conditions
- Neck Pain
- Being tested
- Cervical range of motion
- Keywords
- chronic
- Medical subject headings
- Neck Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical range of motionOther
Patients will fill out the Neck Disability Index, Visual Analogue Pain Rating Scale and the Self-administered Neck range of motion questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Spine Mobility
Patients will fill out the questionnaire once, at the beginning of the study.
Measured: Day one of the study
Secondary outcomes (2)
Pain Visual Analogue Pain Rating Scale
Patients will fill out the questionnaire once, at the beginning of the study.
Measured: Day one of the study
Disability on Neck Disability Index
Patients will fill out the questionnaire once, at the beginning of the study.
Measured: Day one of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startNov 2014
- Primary completionSep 2016
- Study completionNov 2016
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.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Principal investigator, Swanenburg, Balgrist University Hospital
- Investigators
- Jaap Swanenburg, PhD, Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754934
- Sponsor's protocol ID
- 2016-00164
- Other IDs
- 2016
- Status last verified
- Nov 2016
- First submitted
- 25 Apr 2016
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Langenfeld A, Bastiaenen C, Sieben J, Swanenburg J. Development and validation of a self-administered neck mobility assessment tool (S-ROM-Neck) in chronic neck pain patients. Musculoskelet Sci Pract. 2018 Oct;37:75-79. doi: 10.1016/j.msksp.2018.04.004. Epub 2018 Apr 10.
PubMed 29656846
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Self-administered Neck Mobility Assessment Tool in Chronic Neck Pain Patients.
- ClinicalTrials.gov ID
- NCT02754934
- Acronym / sponsor ID
- 2016-00164
- Conditions
- Neck Pain
- Keywords
- chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- Nov 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Apr 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 evaluates, if the movement of the cervical spine, assessed via a specific questionnaire by the patient, is a valid and reliable tool and could be used in daily clinical routine.
Detailed description
Cervical range of motion is a frequently used assessment methods in patients with neck pain.
Although it seems to be used frequently, clinicians still prefer hands-on assessment. Furthermore it is interesting, if cervical range of motion,self-assessed by the patient is a valid and reliable tool.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators will include 50 participants with chronic neck pain
Key inclusion criteria (2 listed)
- Neck pain > 90 days
- Able to speak, read and write German
Key exclusion criteria (1 listed)
- Red Flags e.g. Fracture of the cervical spine
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 |
|---|---|---|
| Cervical range of motionPatients will fill out the Neck Disability Index, Visual Analogue Pain Rating Scale and the Self-administered Neck range of motion questionnaire. | Other | – |
Primary outcome
Cervical Spine Mobility
Time frame: Day one of the study
Patients will fill out the questionnaire once, at the beginning of the study.
2 secondary outcomes
Pain Visual Analogue Pain Rating Scale
Time frame: Day one of the study
Disability on Neck Disability Index
Time frame: Day one of the study
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 4 Nov 2016.
- Derived from this study: PubMed 29656846Langenfeld A, Bastiaenen C, Sieben J, Swanenburg J. Development and validation of a self-administered neck mobility assessment tool (S-ROM-Neck) in chronic neck pain patients. Musculoskelet Sci Pract. 2018 Oct;37:75-79. doi: 10.1016/j.msksp.2018.04.004. Epub 2018 Apr 10.
- 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.
Jaap Swanenburg, PhD principal investigator
Balgrist University Hospital
1 site 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 Balgrist University Hospital at 1 site in Switzerland.
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 2 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 4 Nov 2016. 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 Switzerland. 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?
Cervical Spine Mobility (time frame: Day one of the study). 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 NCT02754934, 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 4 Nov 2016.