HypertensionNCT05420298
Short Term Effect of Cervical Mobilization vs Manipulation on Blood Pressure in Hypertensive Subjects
A study testing cervical mobilization and cervical manipulation in people with Hypertension, run by Cairo University at 1 site in Egypt.
Trial summary
Spinal pain or misalignment is a very common disorder affecting a significant number of populations resulting in substantial disability and economic burden. Various manual therapeutic techniques such as spinal manipulations and mobilizations can be used to treat and manage pain and movement dysfunctions such as spinal… Read more about this study
- Who is it for?
- Ages 27 to 60 years, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- cervical mobilization and cervical manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 4 Jul 2023
- Phase
- Interventional
- 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 27 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- SBP ranging from 135 to 159 mm Hg or DBP ranging from 85 to 99 mm Hg over 3 qualifying BP screening visits
- The age of participants will range from 27 to 60 years old.
- Body mass index of participants will range between < 39 kg/m².
Who cannot join
- cardiovascular diseases or surgery, including second- or third-degree heart block, angina pectoris, defibrillator, valvular disease, recent myocardial infarction, cardiac surgery in the past 12 months.
- history of stroke.
- body mass index (BMI) greater than 39 kg/m2.
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Term Effect of Cervical Mobilization vs Manipulation on Blood Pressure in Hypertensive Subjects( Randomized Control Trial)
Spinal pain or misalignment is a very common disorder affecting a significant number of populations resulting in substantial disability and economic burden. Various manual therapeutic techniques such as spinal manipulations and mobilizations can be used to treat and manage pain and movement dysfunctions such as spinal malalignments and associated complications. These manual therapeutic techniques can affect the cardiovascular parameters .
-
Read the detailed description
Group A group (n=20). All participants will receive only single session of neck mobilization. Grade IV unilateral posteroanterior pressure and sustained extension to be applied restricted joints and muscle energy technique.
- Group B (n=20) will receive single session of neck manipulation with high-velocity, low-amplitude thrust over restricted joints (one at a time) with the goal of restoring normal range of motion in the joint.
- Conditions
- Hypertension
- Being tested
- cervical mobilization, cervical manipulation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical mobilizationOther
All participants will receive only single session of cervical mobilization
cervical manipulationOther
All participants will receive only single session of cervical manipulation
| Study group | Role | What they receive |
|---|---|---|
| cervical mobilization | Experimental | session will include3-5 repetitions of muscle energy technique in combination of facet joint mobilization of unilateral antro-posterior glide and extension repetitions Receives: Other: cervical mobilization |
| cervical manipulation | Active comparator | patients will receive high velocity low amplitude thrust Receives: Other: cervical manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure measurement
systolic pressure - the pressure when your heart pushes blood out and is measured by Mercury sphygmomanometer and stethoscope
Measured: it will be measured immediately before and after single session treatment
Secondary outcomes (4)
diastolic blood pressure
the pressure when your heart rests between beats is measured by Mercury sphygmomanometer and stethoscope
Measured: it will be measured immediately before and after single session treatment
oxygen saturation
Oxygen saturation is a vital parameter to define blood oxygen content and oxygen delivery and is measured by pulse oximetry
Measured: it will be measured immediately before and after single session treatment
perfusion index
Perfusion index is an indication of the pulse strength at the sensor site. The PI's values range from 0.02% for very weak pulse to 20% for extremely strong pulse.Perfusion index is normally monitored with pulse oximeters
Measured: it will be measured immediately before and after single session treatment
pain assessment
The visual analog scale (VAS) is a tool widely used to measure pain
Measured: it will be measured immediately before and after single session treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Jun 2022
- Primary completion20 Apr 2023
- Study completion4 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed El-Moatasem Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420298
- Sponsor's protocol ID
- P.T.REC/012/003253
- Status last verified
- Jul 2023
- First submitted
- 8 Jun 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effect of Cervical Mobilization vs Manipulation on Blood Pressure in Hypertensive Subjects( Randomized Control Trial)
- ClinicalTrials.gov ID
- NCT05420298
- Acronym / sponsor ID
- P.T.REC/012/003253
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 15 Jun 2022 (actual)
- 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.
Spinal pain or misalignment is a very common disorder affecting a significant number of populations resulting in substantial disability and economic burden. Various manual therapeutic techniques such as spinal manipulations and mobilizations can be used to treat and manage pain and movement dysfunctions such as spinal malalignments and associated complications. These manual therapeutic techniques can affect the cardiovascular parameters .
-
Detailed description
Group A group (n=20). All participants will receive only single session of neck mobilization. Grade IV unilateral posteroanterior pressure and sustained extension to be applied restricted joints and muscle energy technique.
- Group B (n=20) will receive single session of neck manipulation with high-velocity, low-amplitude thrust over restricted joints (one at a time) with the goal of restoring normal range of motion in the joint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cervical mobilization | Experimental | Other: cervical mobilizationsession will include3-5 repetitions of muscle energy technique in combination of facet joint mobilization of unilateral antro-posterior glide and extension repetitions |
| cervical manipulation | Active comparator | Other: cervical manipulationpatients will receive high velocity low amplitude thrust |
Who may qualify
- Ages
- 27 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- SBP ranging from 135 to 159 mm Hg or DBP ranging from 85 to 99 mm Hg over 3 qualifying BP screening visits
- The age of participants will range from 27 to 60 years old.
- Body mass index of participants will range between < 39 kg/m².
Key exclusion criteria (4 listed)
- cardiovascular diseases or surgery, including second- or third-degree heart block, angina pectoris, defibrillator, valvular disease, recent myocardial infarction, cardiac surgery in the past 12 months.
- history of stroke.
- body mass index (BMI) greater than 39 kg/m2.
- pregnancy.
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 |
|---|---|---|
| cervical mobilizationAll participants will receive only single session of cervical mobilization | Other | cervical mobilization |
| cervical manipulationAll participants will receive only single session of cervical manipulation | Other | cervical manipulation |
Primary outcome
systolic blood pressure measurement
Time frame: it will be measured immediately before and after single session treatment
systolic pressure - the pressure when your heart pushes blood out and is measured by Mercury sphygmomanometer and stethoscope
4 secondary outcomes
diastolic blood pressure
Time frame: it will be measured immediately before and after single session treatment
oxygen saturation
Time frame: it will be measured immediately before and after single session treatment
perfusion index
Time frame: it will be measured immediately before and after single session treatment
pain assessment
Time frame: it will be measured immediately before and after single session treatment
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 21 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical mobilization and cervical manipulation in people with Hypertension, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 4 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 21 Jul 2023. 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 Egypt. 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?
systolic blood pressure measurement (time frame: it will be measured immediately before and after single session treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2023.