Clinical trial NCT04968639: The Characteristic of Axial Pain and EEG Analysis of Patients After Laminoplasty
Official title: The Characteristic of Axial Pain After Open-door Laminoplasty in Patients With Degenerative Cervical Spine Myelopathy and the Correlation With EEG Analysis: a Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Myelopathy
Keywords: Cervical Myelopathy
Axial Pain
Electroencephalogram Analysis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CSM undergoing C3-7 open-door laminoplasty.

Brief summary: The characteristic of axial pain and EEG analysis of patients after laminoplasty

Detailed description: The characteristic of axial pain after open-door laminoplasty in patients with degenerative cervical spine myelopathy and the correlation with electroencephalogram analysis: a prospective cohort study.

Eligibility criteria: Inclusion Criteria:

* Age: 18\~70 years.
* Diagnosed as degenerative cervical spine myelopathy.
* Must receive C3-C7 open-door laminoplasty.
* Agree to join this study and sign the informed consent.

Exclusion Criteria:

* Severe cervical spine kyphosis.
* Cervical spine radiculopathy.
* Laminoplasty with fusion.
* Cervical spine anterior column lesion because of tumor, trauma or infection.
* Severe osteoporosis.
* Morbid obesity.
* patients with mental disorder.
* Pregnancy.
* History of infection within last 3 months.
* Severe nervous system disease.
* Abnormal laboratory report of liver function, kidney function and hematologic system.
* Poor compliance.
* Patients with other surgical contraindications.
* Patients with intemperance or taking drugs.
* Patients who joined other study within the last 3 months.
* Patients with a chief complaint of neck pain (VAS score ≥3 points).
* Left handedness.

Primary outcomes:
measure: Electroencephalogram analysis
timeFrame: 3 months after surgery.
measure: Electroencephalogram analysis
timeFrame: 1 year after surgery.
measure: Visual analogue scale for axial pain
timeFrame: 3 months after surgery.
measure: Visual analogue scale for axial pain
timeFrame: 1 year after surgery.
Secondary outcomes:
measure: Outcome of cervical spine function
timeFrame: 3 months after surgery.
measure: Outcome of cervical spine function
timeFrame: 1 year after surgery.
measure: Quality of life outcome
timeFrame: 3 months after surgery.
measure: Quality of life outcome
timeFrame: 1 year after surgery.
measure: Psychological measures
timeFrame: 3 month after surgery.
measure: Psychological measures
timeFrame: 1 year after surgery.
measure: Psychological measures
timeFrame: 3 month after surgery.
measure: Psychological measures
timeFrame: 1 year after surgery.
measure: Trail Making Test
timeFrame: 3 month after surgery.
measure: Trail Making Test
timeFrame: 1 year after surgery.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Ming Yi
state: Beijing
city: Beijing
country: China
facility: Feifei Zhou
state: Beijing
Study officials:
References: