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OpenTrials
Completed

NCT Number: NCT02016768

Decompressive Cervical Surgery and Hypertension

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.

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Key information

Conditions

Myelopathy, Compressive Cardiovascular Diseases Central Nervous System Diseases Hypertension Nervous System Diseases Spinal Cord Compression Spinal Cord Diseases Spinal Cord Injuries Vascular Diseases Wounds and Injuries

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hong LIu

Beijing, Beijing Municipality, 100433, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

decompressive cervical surgery

Procedure

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

Primary outcomes

  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.

    Time frame: twice ABPM prior to operation and 1st month, 3th month post-operation.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Peking University

Registry information

Official study title

Decompressive Cervical Surgery for Antihypertensive Effect in Patients With Cervical Spondylosis and Hypertension-A Cohort Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 20, 2013
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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