Neck PainNCT02671370
Cervical Range of Motion in Neck Pain Patients: A Mixed Methods Study
An observational study of Neck Pain, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
This study there are any associations between objective and subjective outcome measures, measuring the cervical range of motion and if the restriction matter to the patient. 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?
- Measurement of the range of motion of the cervical spine
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2016to May 2017
- 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: Participants with neck pain of any duration
Who may be able to join
- Patients with any duration of neck pain
- Men and women older than 18 years
- Signed informed consent
Who cannot join
- Disc herniation of the cervical spine
- Spinal canal stenosis
- Acute accidents
- Surgery of the cervical spine
- Pacemaker and / or defibrillator
Trial locations and contacts
1 site in 1 country.
About this study
This study there are any associations between objective and subjective outcome measures, measuring the cervical range of motion and if the restriction matter to the patient.
Read the detailed description
Objective and subjective outcome measures are frequently used assessments in clinical practice.
The investigators will use different subjective and objective outcome measures to evaluate any possible associations, as well as to investigate if restrictions of movement matters to patients.
Additionally to the assessments tools the investigators will use interviews to extend the scope.
- Conditions
- Neck Pain
- Being tested
- Measurement of the range of motion of the cervical spine
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of the range of motion of the cervical spineOther
There is no intervention. Only measurements and interviews are taken.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Range of Motion (CROM)
The cervical range of motion will be measured using the CROM device
Measured: Baseline
Secondary outcomes (3)
Neck Disability Index
Questionnaire, measuring the subjective restriction of the participant during activities of daily living
Measured: Baseline
S-ROM-Neck
Questionnaire, the participants will be asked to assess their ability to move there neck and if they feel restricted.
Measured: Baseline
Interviews (personal,semi-structured guided, open-ended questions) in a one-to-one Setting. Recorded with a voice-recorder.
10 of the participants will be asked to also take part in an interview.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2017
- Study completionMay 2017
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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 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
- NCT02671370
- Sponsor's protocol ID
- 2015-00049
- Other IDs
- 2015
- Status last verified
- May 2017
- First submitted
- 29 Jan 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no there is not
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Range of Motion in Neck Pain Patients: A Mixed Methods Study
- ClinicalTrials.gov ID
- NCT02671370
- Acronym / sponsor ID
- 2015-00049
- Conditions
- Neck Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- Jan 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 2 Feb 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 there are any associations between objective and subjective outcome measures, measuring the cervical range of motion and if the restriction matter to the patient.
Detailed description
Objective and subjective outcome measures are frequently used assessments in clinical practice.
The investigators will use different subjective and objective outcome measures to evaluate any possible associations, as well as to investigate if restrictions of movement matters to patients.
Additionally to the assessments tools the investigators will use interviews to extend the scope.
Study design
- Observational model
- Other
- 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
- Participants with neck pain of any duration
Key inclusion criteria (3 listed)
- Patients with any duration of neck pain
- Men and women older than 18 years
- Signed informed consent
Key exclusion criteria (5 listed)
- Disc herniation of the cervical spine
- Spinal canal stenosis
- Acute accidents
- Surgery of the cervical spine
- Pacemaker and / or defibrillator
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 |
|---|---|---|
| Measurement of the range of motion of the cervical spineThere is no intervention. Only measurements and interviews are taken. | Other | – |
Primary outcome
Cervical Range of Motion (CROM)
Time frame: Baseline
The cervical range of motion will be measured using the CROM device
3 secondary outcomes
Neck Disability Index
Time frame: Baseline
S-ROM-Neck
Time frame: Baseline
Interviews (personal,semi-structured guided, open-ended questions) in a one-to-one Setting. Recorded with a voice-recorder.
Time frame: Baseline
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 9 May 2017.
- Individual participant dataSharing planned: No. no there is not
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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 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 9 May 2017. 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 Range of Motion (CROM) (time frame: Baseline). 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 2017.