The Characteristic of Axial Pain and EEG Analysis of Patients After Laminoplasty
1 other identifier
observational
80
1 country
2
Brief Summary
The characteristic of axial pain and EEG analysis of patients after laminoplasty
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2019
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
June 27, 2021
CompletedFirst Posted
Study publicly available on registry
July 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedNovember 1, 2022
October 1, 2022
4 years
June 27, 2021
October 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Electroencephalogram analysis
Electroencephalogram analysis (focus on the gamma oscillation at prefrontal cortex) at 3-month follow-up.
3 months after surgery.
Electroencephalogram analysis
Electroencephalogram analysis (focus on the gamma oscillation at prefrontal cortex) at 1-year follow-up.
1 year after surgery.
Visual analogue scale for axial pain
Visual analogue scale for axial pain before operation and at 3-month follow-up
3 months after surgery.
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 Outcomes (10)
Outcome of cervical spine function
3 months after surgery.
Outcome of cervical spine function
1 year after surgery.
Quality of life outcome
3 months after surgery.
Quality of life outcome
1 year after surgery.
Psychological measures
3 month after surgery.
- +5 more secondary outcomes
Study Arms (2)
Axial pain positive group
Postoperative VAS score ≥ 3 points at 3-month follow-up
Axial pain negative group
Postoperative VAS score ≤ 2 points at 3-month follow-up
Eligibility Criteria
Patients with CSM undergoing C3-7 open-door laminoplasty.
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ming Yi
Beijing, Beijing Municipality, 100083, China
Feifei Zhou
Beijing, Beijing Municipality, 100191, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2021
First Posted
July 20, 2021
Study Start
January 1, 2019
Primary Completion
December 30, 2022
Study Completion
December 31, 2022
Last Updated
November 1, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share