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NCT Number: 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.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhua Christian Hospital Taiwan

Changhua, 500, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no intervention was used in this observational study

Other

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. The values of neck flexor, extensor, lateral bending and rotation strength

    Time frame: 1 day ( first visit)

    measured with a handheld dynamometer

  5. 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

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 13, 2015
Registry last updated
Nov 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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