Myelopathy, CompressiveNCT02016768
Decompressive Cervical Surgery and Hypertension
An observational study of Myelopathy, Compressive and Hypertension, run by Peking University First Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Myelopathy, Compressive, Hypertension
- What is being tested?
- decompressive cervical surgery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at our Spine Center suffering signs and symptoms of cervical myelopathy and with evidence of radiographic cervical cord compression with hypertension.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Myelopathy, Compressive, Hypertension
- Being tested
- decompressive cervical surgery
- Medical subject headings
- Spinal Cord Compression, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decompressive cervical surgeryProcedure or surgery
Also called anterior cervical discectomy fusion, posterior laminoplasty
To make decompressive cervical surgery, either anterior cervical discectomy and fusion or posterior laminoplasty on the patients suffering from cervical spondylotic myelopathy and hypertension.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: decompressive cervical surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: twice ABPM prior to operation and 1st month, 3th month post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startJun 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myelopathy, CompressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Principal investigator, Hong Liu, Peking University First Hospital
- Investigators
- Hong Liu, Master, Principal investigator, Peking Unversity First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016768
- Sponsor's protocol ID
- PUCRP201304
- Status last verified
- Jan 2020
- First submitted
- 15 Dec 2013
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decompressive Cervical Surgery for Antihypertensive Effect in Patients With Cervical Spondylosis and Hypertension-A Cohort Study
- ClinicalTrials.gov ID
- NCT02016768
- Acronym / sponsor ID
- PUCRP201304
- Conditions
- Myelopathy, Compressive, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| operation | – | Procedure: decompressive cervical surgeryTo make decompressive cervical surgery, either anterior cervical discectomy and fusion or posterior laminoplasty on the patients suffering from cervical spondylotic myelopathy and hypertension. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at our Spine Center suffering signs and symptoms of cervical myelopathy and with evidence of radiographic cervical cord compression with hypertension.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| decompressive cervical surgeryAlso: anterior cervical discectomy fusion, posterior laminoplastyTo make decompressive cervical surgery, either anterior cervical discectomy and fusion or posterior laminoplasty on the patients suffering from cervical spondylotic myelopathy and hypertension. | Procedure or surgery | operation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 26738624Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Liu, Master principal investigator
Peking Unversity First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelopathy, Compressive and Hypertension, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02016768, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020; AzTrials last refreshed its copy on 27 Oct 2026.