- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02362555
The Effect of Nuchal Ligament Calcification on Cervical Function in Patients With Neck Pain
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Changhua, Taiwan, 500
- Changhua Christian Hospital Taiwan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient with neck pain and stiffness last for more than 1 month
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ossification of nuchal ligament
check neck function, radiography characteristics and complete functional disability questionnaire
|
|
Non ossification of nuchal ligament
check neck function, radiography characteristics and complete functional disability questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 day ( first visit)
|
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
|
within one week after first visit
|
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
|
1 day ( first visit)
|
The values of neck flexor, extensor, lateral bending and rotation strength
Time Frame: 1 day ( first visit)
|
measured with a handheld dynamometer
|
1 day ( first visit)
|
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
|
1 day ( first visit)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCH-140305
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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