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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04968639
Collaborator
(none)
80
Enrollment
2
Locations
48
Anticipated Duration (Months)
40
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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.
    Actual Study Start Date :
    Jan 1, 2019
    Anticipated Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Electroencephalogram analysis [3 months after surgery.]

      Electroencephalogram analysis (focus on the gamma oscillation at prefrontal cortex) at 3-month follow-up.

    2. Electroencephalogram analysis [1 year after surgery.]

      Electroencephalogram analysis (focus on the gamma oscillation at prefrontal cortex) at 1-year follow-up.

    3. Visual analogue scale for axial pain [3 months after surgery.]

      Visual analogue scale for axial pain before operation and at 3-month follow-up

    4. 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

    1. Outcome of cervical spine function [3 months after surgery.]

      Neck Disability Index score before operation and at 3-month follow-up

    2. Outcome of cervical spine function [1 year after surgery.]

      Neck Disability Index score before operation and at 1-year follow-up

    3. Quality of life outcome [3 months after surgery.]

      SF-36 score before operation and at 3-month follow-up

    4. Quality of life outcome [1 year after surgery.]

      SF-36 score before operation and at 1-year follow-up

    5. Psychological measures [3 month after surgery.]

      Beck Depression Inventory score before operation and at 3-month follow-up

    6. Psychological measures [1 year after surgery.]

      Beck Depression Inventory score before operation and at 1-year follow-up

    7. Psychological measures [3 month after surgery.]

      Beck Anxiety Inventory score before operation and at 3-month follow-up

    8. Psychological measures [1 year after surgery.]

      Beck Anxiety Inventory score before operation and at 1-year follow-up

    9. Trail Making Test [3 month after surgery.]

      Trail Making Test before operation and at 3-month follow-up

    10. Trail Making Test [1 year after surgery.]

      Trail Making Test before operation and at 1-year follow-up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ming Yi Beijing Beijing China 100083
    2 Feifei Zhou Beijing Beijing China 100191

    Sponsors and Collaborators

    • Peking University Third Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT04968639
    Other Study ID Numbers:
    • M2019197
    First Posted:
    Jul 20, 2021
    Last Update Posted:
    Jul 20, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking University Third Hospital
    Cervical Myelopathy
    Axial Pain
    Electroencephalogram Analysis
    Additional relevant MeSH terms:
    Spinal Cord Diseases
    Bone Marrow Diseases

    Study Results

    No Results Posted as of Jul 20, 2021