Decompressive Cervical Surgery and Hypertension

NCT02016768 | Completed DMC

• 1 other identifier: PUCRP201304
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelopathy, Compressive; Hypertension

Outcome Measures

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.

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

Study Arms (1)

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.

Procedure: decompressive cervical surgery

Interventions

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.

Also known as: anterior cervical discectomy fusion, posterior laminoplasty

operation

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University: collaborator

Study Sites (1)

Hong LIu

Beijing, Beijing Municipality, 100433, China

Location

Related Publications (1)

• 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.

  PMID: 26738624 DERIVED

MeSH Terms

Conditions

Spinal Cord Compression; Hypertension

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hong Liu, Master

  Peking Unversity First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 15, 2013
• First Posted: December 20, 2013
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

CN (1)