ClinicalTrials.gg
CompletedNCT02016768Updated Jan 13, 2020

Decompressive Cervical Surgery and Hypertension

An observational study in Myelopathy, Compressive and Hypertension, sponsored by Peking University First Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by Peking University First Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 84 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Myelopathy, Compressive
  • Hypertension
03

In context

Spinal Cord Compression

52 studies on the registry are indexed under Spinal Cord Compression; 19 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 17 observational studies indexed under Spinal Cord Compression.

Browse Spinal Cord Compression studies →

Lead sponsor

Peking University First Hospital is the lead sponsor of 390 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form for participation in this study

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Proceduredecompressive 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.

    Also known as: anterior cervical discectomy fusion, posterior laminoplasty

06

What researchers measure

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.

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

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Study locations

1 site
  • Hong LIu
    Beijing, Beijing 100433, China
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References and documents

Publications

  • 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. PubMed 26738624 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2014 to primary completion in Dec 2016, 30 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2013
First posted
Dec 20, 2013
StartActual
Jun 2014
Primary completionActual
Dec 2016
CompletionActual
Dec 2016
Last update
Jan 13, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02016768
Collaborators
Peking University
Responsible party
Hong Liu (Dr., Peking University First Hospital) — Principal investigator
First posted
Dec 20, 2013
Start date
Jun 2014
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jan 13, 2020

Study contacts

Hong Liu, Master
principal investigator · Peking Unversity First Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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