The Characteristic of Axial Pain and EEG Analysis of Patients After Laminoplasty

Cervical Myelopathy Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04968639
• Other study ID #: M2019197
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2022
• Source: Peking University Third Hospital
• Contact: Feifei Zhou, M.D.
• Phone: +8613581787350
• Email: orthozhou[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The characteristic of axial pain and EEG analysis of patients after laminoplasty

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: December 30, 2022
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervical Myelopathy
• Spinal Cord Diseases

Locations

Country	Name	City	State
China	Feifei Zhou	Beijing	Beijing
China	Ming Yi	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electroencephalogram analysis	Electroencephalogram analysis (focus on the gamma oscillation at prefrontal cortex) at 3-month follow-up.	3 months after surgery.
Primary	Electroencephalogram analysis	Electroencephalogram analysis (focus on the gamma oscillation at prefrontal cortex) at 1-year follow-up.	1 year after surgery.
Primary	Visual analogue scale for axial pain	Visual analogue scale for axial pain before operation and at 3-month follow-up	3 months after surgery.
Primary	Visual analogue scale for axial pain	Visual analogue scale for axial pain before operation and at 1-year follow-up	1 year after surgery.
Secondary	Outcome of cervical spine function	Neck Disability Index score before operation and at 3-month follow-up	3 months after surgery.
Secondary	Outcome of cervical spine function	Neck Disability Index score before operation and at 1-year follow-up	1 year after surgery.
Secondary	Quality of life outcome	SF-36 score before operation and at 3-month follow-up	3 months after surgery.
Secondary	Quality of life outcome	SF-36 score before operation and at 1-year follow-up	1 year after surgery.
Secondary	Psychological measures	Beck Depression Inventory score before operation and at 3-month follow-up	3 month after surgery.
Secondary	Psychological measures	Beck Depression Inventory score before operation and at 1-year follow-up	1 year after surgery.
Secondary	Psychological measures	Beck Anxiety Inventory score before operation and at 3-month follow-up	3 month after surgery.
Secondary	Psychological measures	Beck Anxiety Inventory score before operation and at 1-year follow-up	1 year after surgery.
Secondary	Trail Making Test	Trail Making Test before operation and at 3-month follow-up	3 month after surgery.
Secondary	Trail Making Test	Trail Making Test before operation and at 1-year follow-up	1 year after surgery.