Short Term Effect of Cervical Mobilization vs Manipulation on Blood Pressure in Hypertensive Subjects

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 .

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Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: cervical mobilization; Other: cervical manipulation

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alaa El-Moatasem, lecturer; Phone Number: 01006625054; Email: alaamotasem@rocketmail.com
• Study Contact Backup: Name: donia El-Masry, Lecturer; Phone Number: 01005587119; Email: egydodo@rocketmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11432
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 27 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cervical mobilization; session will include3-5 repetitions of muscle energy technique in combination of facet joint mobilization of unilateral antro-posterior glide and extension repetitions	Other: cervical mobilization; All participants will receive only single session of cervical mobilization
Active Comparator: cervical manipulation; patients will receive high velocity low amplitude thrust	Other: cervical manipulation; All participants will receive only single session of cervical manipulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systolic blood pressure measurement	systolic pressure - the pressure when your heart pushes blood out and is measured by Mercury sphygmomanometer and stethoscope	it will be measured immediately before and after single session treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diastolic blood pressure	the pressure when your heart rests between beats is measured by Mercury sphygmomanometer and stethoscope	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	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	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	it will be measured immediately before and after single session treatment

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): April 20, 2023
• Study Completion (Actual): July 4, 2023

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: P.T.REC/012/003253

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No