Decompressive Cervical Surgery and Hypertension

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016768
• Other study ID #: PUCRP201304
• Status: Completed
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2020
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Myelopathy, Compressive
• Spinal Cord Compression
• Spinal Cord Diseases

Intervention

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.

Locations

Country	Name	City	State
China	Hong LIu	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University First Hospital	Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.