The Effect of Nuchal Ligament Calcification on Cervical Function in Patients With Neck Pain

November 10, 2015 updated by: Ta-Sen Wei,MD, Changhua Christian Hospital

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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Changhua, Taiwan, 500
        • Changhua Christian Hospital Taiwan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patient with chronic neck pain

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

January 21, 2015

First Submitted That Met QC Criteria

February 9, 2015

First Posted (Estimate)

February 13, 2015

Study Record Updates

Last Update Posted (Estimate)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 10, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

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.

Clinical Trials on Neck Pain

Clinical Trials on no intervention was used in this observational study

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