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: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: no intervention was used in this observational study

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• Taiwan
  • Changhua, Taiwan, 500
    • Changhua Christian Hospital Taiwan

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ossification of nuchal ligament; check neck function, radiography characteristics and complete functional disability questionnaire	Other: no intervention was used in this observational study
Non ossification of nuchal ligament; check neck function, radiography characteristics and complete functional disability questionnaire	Other: no intervention was used in this observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	1 day ( first visit)
The values of neck flexor, extensor, lateral bending and rotation strength	measured with a handheld dynamometer	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	1 day ( first visit)

Collaborators and Investigators

• Sponsor: Changhua Christian Hospital

Study record dates

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

• Keywords: Ossification of nuchal ligament
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: CCH-140305