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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362555
• Other study ID #: CCH-140305
• Status: Completed
• Phase: N/A
• First received: January 21, 2015
• Last updated: November 10, 2015
• Start date: April 2014
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Calcinosis
• Neck Pain

Intervention

Other:
• no intervention was used in this observational study

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital Taiwan	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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	Yes
Primary	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)	No
Primary	The values of neck flexor, extensor, lateral bending and rotation strength	measured with a handheld dynamometer	1 day ( first visit)	No
Primary	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)	No