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Decompressive Cervical Surgery and Hypertension

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ClinicalTrials.gov Identifier: NCT02016768
Recruitment Status : Recruiting
First Posted : December 20, 2013
Last Update Posted : October 3, 2016
Sponsor:
Collaborator:
Peking University
Information provided by (Responsible Party):
Hong Liu, Peking University First Hospital

December 15, 2013
December 20, 2013
October 3, 2016
January 2014
December 2016   (Final data collection date for primary outcome 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. [ Time Frame: twice ABPM prior to operation and 1st month, 3th month post-operation. ]
Same as current
Complete list of historical versions of study NCT02016768 on ClinicalTrials.gov Archive Site
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Decompressive Cervical Surgery and Hypertension
Decompressive Cervical Surgery for Antihypertensive Effect in Patients With Cervical Spondylosis and Hypertension-A Cohort Study
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients at our Spine Center suffering signs and symptoms of cervical myelopathy and with evidence of radiographic cervical cord compression with hypertension.
  • Myelopathy, Compressive
  • 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
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.
Intervention: Procedure: decompressive cervical surgery
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
100
December 2016
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 84 Years   (Adult, Older Adult)
No
Contact: Shijun Wang, Doctor 86-10-83572642 doctorwang444@aliyun.com
Contact: Lei Yue, Bachlor 86-18217022500 yueleimail@foxmail.com
China
 
 
NCT02016768
PUCRP201304
Yes
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Hong Liu, Peking University First Hospital
Peking University First Hospital
Peking University
Principal Investigator: Hong Liu, Master Peking Unversity First Hospital
Peking University First Hospital
September 2016