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

Recruiting

• Conditions: Cervical Myelopathy

• Registration Number: NCT04968639
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-07-08
• Study First Posted: 2021-07-20
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-29
• Last Update Posted: 2022-11-01
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Electroencephalogram analysis	1 year after surgery.	Electroencephalogram analysis (focus on the gamma oscillation at prefrontal cortex) at 1-year follow-up.
Visual analogue scale for axial pain	1 year after surgery.	Visual analogue scale for axial pain before operation and at 1-year follow-up

Secondary Outcome Measures

Name	Time	Method
Outcome of cervical spine function	1 year after surgery.	Neck Disability Index score before operation and at 1-year follow-up
Trail Making Test	1 year after surgery.	Trail Making Test before operation and at 1-year follow-up
Quality of life outcome	1 year after surgery.	SF-36 score before operation and at 1-year follow-up
Psychological measures	1 year after surgery.	Beck Anxiety Inventory score before operation and at 1-year follow-up

Trial Locations

Locations (2)

Ming Yi; 🇨🇳 Beijing, Beijing, China

Feifei Zhou; 🇨🇳 Beijing, Beijing, China