NCT05420298

Brief 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 malalignments and associated complications. These manual therapeutic techniques can affect the cardiovascular parameters . \-

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2023

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

June 8, 2022

Last Update Submit

July 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • diastolic blood pressure

    it will be measured immediately before and after single session treatment

  • oxygen saturation

    it will be measured immediately before and after single session treatment

  • perfusion index

    it will be measured immediately before and after single session treatment

  • pain assessment

    it will be measured immediately before and after single session treatment

Study Arms (2)

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

Other: cervical mobilization

cervical manipulation

ACTIVE COMPARATOR

patients will receive high velocity low amplitude thrust

Other: cervical manipulation

Interventions

All participants will receive only single session of cervical mobilization

cervical mobilization

All participants will receive only single session of cervical manipulation

cervical manipulation

Eligibility Criteria

Age27 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11432, Egypt

Location

MeSH Terms

Conditions

Hypertension

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 15, 2022

Study Start

June 1, 2022

Primary Completion

April 20, 2023

Study Completion

July 4, 2023

Last Updated

July 21, 2023

Record last verified: 2023-07

Locations