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Decompressive Cervical Surgery and Hypertension

Sponsor
Peking University First Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02016768
Collaborator
Peking University (Other)
50
Enrollment
1
Location
30
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is a relationship between CSM and hypertension, probably a cause/effect relationship, and investigators term this type of hypertension "cervicogenic hypertension". Abnormally functioning serotonergic pacemaker cells in the dorsal raphe nucleus inappropriately activate and inhibit parts of the central and autonomic nervous systems as part of a chronic stress response, which causes hypertension and migraine. This theory is now being expanded to encompass both CSM and essential hypertension, the idea being that these two conditions are intimately related.

Condition or Disease Intervention/Treatment Phase
  • Procedure: decompressive cervical surgery

Detailed Description

Cervical spondylotic myelopathy (CSM) and hypertension are both very common diseases in the general population.Investigators have also observed previously hypertensive patients with CSM become normotensive following decompressive cervical surgery and no longer need antihypertensive medications. Both observations are difficult to explain according to current theories of the two diseases.

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Decompressive Cervical Surgery for Antihypertensive Effect in Patients With Cervical Spondylosis and Hypertension-A Cohort Study
Actual Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
operation

To make decompressive cervical surgery, either anterior cervical discectomy and fusion or posterior laminoplasty on the patients suffering from cervical spondylotic myelopathy and hypertension.

Procedure: decompressive cervical surgery
To make decompressive cervical surgery, either anterior cervical discectomy and fusion or posterior laminoplasty on the patients suffering from cervical spondylotic myelopathy and hypertension.
Other Names:
  • anterior cervical discectomy fusion
  • posterior laminoplasty

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in the systolic blood pressure(SBP) measured by 24-hour Ambulatory Blood Pressure Monitoring(ABPM) on 1st month and 3th month post-operation. [twice ABPM prior to operation and 1st month, 3th month post-operation.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 84 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Established diagnosis of cervical spondylosis myelopathy

    • Be at least 18 years of age

    • Office-measured systolic BP≧140mmHg

    • Ability to adhere to study protocol

    • Have signed an approved informed consent form for participation in this study

    Exclusion Criteria:

    • Have hypertension secondary to a treatable cause

    • Have prior cervical spine surgery

    • Are pregnant or contemplating pregnancy during the 3-month follow-up period

    • People deny to join the study

    • Are unable to comply with protocol requirements

    • Are unlikely to survive the protocol follow-up period

    • Are enrolled in another concurrent clinical trial

    • Visual Analogue Scale≥4

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hong LIu Beijing Beijing China 100433

    Sponsors and Collaborators

    • Peking University First Hospital
    • Peking University

    Investigators

    • Principal Investigator: Hong Liu, Master, Peking Unversity First Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hong Liu, Dr., Peking University First Hospital
    ClinicalTrials.gov Identifier:
    NCT02016768
    Other Study ID Numbers:
    • PUCRP201304
    First Posted:
    Dec 20, 2013
    Last Update Posted:
    Jan 13, 2020
    Last Verified:
    Jan 1, 2020
    Additional relevant MeSH terms:
    Spinal Cord Diseases
    Spinal Cord Compression
    Hypertension

    Study Results

    No Results Posted as of Jan 13, 2020