Clinical trial NCT02016768: Decompressive Cervical Surgery and Hypertension
Official title: Decompressive Cervical Surgery for Antihypertensive Effect in Patients With Cervical Spondylosis and Hypertension-A Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelopathy, Compressive
Hypertension
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
First posted: 2013-12-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at our Spine Center suffering signs and symptoms of cervical myelopathy and with evidence of radiographic cervical cord compression with hypertension.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: twice ABPM prior to operation and 1st month, 3th month post-operation.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Hong LIu
state: Beijing
Study officials:
affiliation: Peking Unversity First Hospital
name: Hong Liu, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu H, Wang HB, Wu L, Wang SJ, Yang ZC, Ma RY, Reilly KH, Yan XY, Ji P, Wu YF. Effects of decompressive cervical surgery on blood pressure in cervical spondylosis patients with hypertension: a time series cohort study. BMC Surg. 2016 Jan 6;16:2. doi: 10.1186/s12893-015-0117-y.