Decompressive Cervical Surgery and Hypertension

Completed

• Conditions: Myelopathy, Compressive; Hypertension
• Interventions: Procedure: decompressive cervical surgery

• Registration Number: NCT02016768
• Lead Sponsor: Peking University First Hospital

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.

Study Timeline

• Study First Submitted: 2013-12-15
• Study First Submitted QC: 2013-12-15
• Study First Posted: 2013-12-20
• Study Start: 2014-06
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
operation	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hong LIu; 🇨🇳 Beijing, Beijing, China