Neck PainNCT02362555
The Effect of Nuchal Ligament Calcification on Cervical Function in Patients With Neck Pain
An observational study of Neck Pain, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
Ossification of nuchal ligament often observed in patient with chronic neck pain, previous study showed ossification of nuchal ligament was associated with cervical spondylosis and radiculopathy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Neck Pain
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2014to Aug 2015
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with chronic neck pain
Who may be able to join
- Patient with neck pain and stiffness last for more than 1 month
Who cannot join
- cervical trauma or fracture in 3 months
- evidence of cervical spine instability
- rheumatoid cervical spondylopathy
- previous cervical surgery
- head and neck cancer
- previous radiotherapy over neck and surrounding
- those complicated with myelopathy
- contraindication to radiography like pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Ossification of nuchal ligament often observed in patient with chronic neck pain, previous study showed ossification of nuchal ligament was associated with cervical spondylosis and radiculopathy. Patient with chronic neck pain was divided into two groups according to the presence of ossification of nuchal ligament on cervical radiographic images.
This study is to evaluate and compare the neck function including range of motion, neck strength and pressure pain threshold, radiography characteristics and functional disability between two groups.
- Conditions
- Neck Pain
- Being tested
- no intervention was used in this observational study
- Keywords
- Ossification of nuchal ligament
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention was used in this observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| ossification of nuchal ligament | check neck function, radiography characteristics and complete functional disability questionnaire Receives: Other: no intervention was used in this observational study | |
| Non ossification of nuchal ligament | check neck function, radiography characteristics and complete functional disability questionnaire Receives: Other: no intervention was used in this observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degrees of cervical range of motion
active range of motion in flexion, extension,lateral bending and rotation direction with Cervical Range of Motion (CROM) instrument
Measured: 1 day ( first visit)
Angles of cervical lordotic curve at C2-C7 on cervical x-ray
measured by both modified Cobb method and Harrison posterior tangent method at C2-C7 in every participants
Measured: within one week after first visit
Scores of functional disability as a measure of effects of neck pain on daily living
neck disability index (NDI) with 10-item scaled questionnaire
Measured: 1 day ( first visit)
The values of neck flexor, extensor, lateral bending and rotation strength
measured with a handheld dynamometer
Measured: 1 day ( first visit)
The values of pressure pain threshold as a measure of participants' pain sensitivity
Pressure gauge algometer was applied to bilateral upper trapezius
Measured: 1 day ( first visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startApr 2014
- Primary completionAug 2015
- Study completionAug 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ta-Sen Wei,MD, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362555
- Sponsor's protocol ID
- CCH-140305
- Status last verified
- Nov 2015
- First submitted
- 21 Jan 2015
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nuchal Ligament Calcification on Cervical Function in Patients With Neck Pain
- ClinicalTrials.gov ID
- NCT02362555
- Acronym / sponsor ID
- CCH-140305
- Conditions
- Neck Pain
- Keywords
- Ossification of nuchal ligament
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Feb 2015 (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.
Ossification of nuchal ligament often observed in patient with chronic neck pain, previous study showed ossification of nuchal ligament was associated with cervical spondylosis and radiculopathy. Patient with chronic neck pain was divided into two groups according to the presence of ossification of nuchal ligament on cervical radiographic images.
This study is to evaluate and compare the neck function including range of motion, neck strength and pressure pain threshold, radiography characteristics and functional disability between two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ossification of nuchal ligament | – | Other: no intervention was used in this observational studycheck neck function, radiography characteristics and complete functional disability questionnaire |
| Non ossification of nuchal ligament | – | Other: no intervention was used in this observational studycheck neck function, radiography characteristics and complete functional disability questionnaire |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with chronic neck pain
Key inclusion criteria (1 listed)
- Patient with neck pain and stiffness last for more than 1 month
Key exclusion criteria (8 listed)
- cervical trauma or fracture in 3 months
- evidence of cervical spine instability
- rheumatoid cervical spondylopathy
- previous cervical surgery
- head and neck cancer
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 |
|---|---|---|
| no intervention was used in this observational study | Other | Non ossification of nuchal ligament, ossification of nuchal ligament |
Primary outcome
Degrees of cervical range of motion
Time frame: 1 day ( first visit)
active range of motion in flexion, extension,lateral bending and rotation direction with Cervical Range of Motion (CROM) instrument
Angles of cervical lordotic curve at C2-C7 on cervical x-ray
Time frame: within one week after first visit
measured by both modified Cobb method and Harrison posterior tangent method at C2-C7 in every participants
Scores of functional disability as a measure of effects of neck pain on daily living
Time frame: 1 day ( first visit)
neck disability index (NDI) with 10-item scaled questionnaire
The values of neck flexor, extensor, lateral bending and rotation strength
Time frame: 1 day ( first visit)
measured with a handheld dynamometer
The values of pressure pain threshold as a measure of participants' pain sensitivity
Time frame: 1 day ( first visit)
Pressure gauge algometer was applied to bilateral upper trapezius
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 13 Nov 2015.
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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.
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 Changhua Christian Hospital at 1 site in Taiwan.
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 8 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 13 Nov 2015. 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 Taiwan. 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?
Degrees of cervical range of motion (time frame: 1 day ( first visit)). The study lists 5 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 13 Nov 2015.