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

NCT ID: NCT04968639

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cervical Myelopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Axial pain positive group

Postoperative VAS score ≥ 3 points at 3-month follow-up

No interventions assigned to this group

Axial pain negative group

Postoperative VAS score ≤ 2 points at 3-month follow-up

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ming Yi

Beijing, Beijing Municipality, China

Site Status RECRUITING

Feifei Zhou

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Feifei Zhou, M.D.

Role: CONTACT

+8613581787350

Facility Contacts

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Mi Yi, Ph.D.

Role: primary

+ 86(0)10 8280 5083

Feifei Zhou, M.D.

Role: primary

+8613581787350

Other Identifiers

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M2019197

Identifier Type: -

Identifier Source: org_study_id

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