Efficacy of Physical Therapy Intervention in Cervical Angina Patients at Jerash University Office Employees, "Randomized Clinical Trail".

April 4, 2024 updated by: Ibrahim Abuzaid, South Valley University
Cervicogenic angina (CA) is defined as paroxysmal angina- like pain that originates from the disorders of the cervical spine or other neck structures. Because CA mimics typical cardiac angina, symptoms in the elderly with cervical spondylosis are more frequently misdiagnosed Nakajima H, 2006. Patients with CA may have suffered symptoms for longer periods of time and seen several clinicians due to conflicting cardiac exams. Clinicians and patients are unaware that CA symptoms are stemming from cervical spine disorders. However, the mechanism of pain occurrence in patients with CA remains unclear.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Randomized Control Trail (RCT) will be used in the study. Participants will be divided into two groups (experimental and control groups). Each group will include 30 participants.

The study population will be employees working in JU from different departments.

A total of 60 participants will be included in the study. Their weight ranged from (50 kilograms) to (100 kilograms). And their height ranged from (150 centimeters) to (190 centimeters). And their body mass index ranged from (22.2) to (27.7). This will be divided into 2 groups with 30 participants in each group.

The data collected will focus on measuring the Range of Motion (ROM) of the cervical spine using an Electro-Goniometer, the pain using Visual Analogue Scale (VAS), and the Hart Rate (HR) using an electro cardio Graphic (ECG).

The study setting will be JU, located in Jerash City, Jordan.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • cervical spondylosis, cervical disc, cervical instability

Exclusion Criteria:

  • Cardiovascular diseases ( ischemic heart disease, heart failure, valvular disease)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Efficacy of Physical Therapy Intervention in Cervical Angina Patients
Randomized Control Trail (RCT) will be used in the study. Participants will be dived into experimental group and control group. Each group will includes 30 participants.The physiotherapy program intervention will includes cervical traction, cervical mobilization, Sub occipital release, Muscle energy technique. and ultra sound with parameters 5 min × 3 times × 4 weeks, 1 MHz, continuous: 1.5 W/cm2; pulsed: 2.5 W/cm2, for study group.
Other: Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique)
Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique) strengthening exercises for neck muscles, ultrasound with parameters 5 min × 3 times × 4 weeks, 1 MHz, continuous: 1.5 W/cm2; pulsed: 2.5 W/cm2.
Other Names:
  • Strengthening exercises for neck muscles, ultrasound with parameters 5 min × 3 times × 4 weeks, 1 MHz, continuous: 1.5 W/cm2; pulsed: 2.5 W/cm2,
Placebo Comparator: know the effect of Physical Therapy Intervention in Cervical Angina Patients
30 participants in control.The physiotherapy program intervention will include ultrasound with parameters 5 min × 3 times × 4 weeks, 1 MHz, continuous: 1.5 W/cm2; pulsed: 2.5 W/cm2
Other: Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique)
Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique) strengthening exercises for neck muscles, ultrasound with parameters 5 min × 3 times × 4 weeks, 1 MHz, continuous: 1.5 W/cm2; pulsed: 2.5 W/cm2.
Other Names:
  • Strengthening exercises for neck muscles, ultrasound with parameters 5 min × 3 times × 4 weeks, 1 MHz, continuous: 1.5 W/cm2; pulsed: 2.5 W/cm2,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-Hart Rate (HR) (bpm) using Electro Cardiac Graphic (ECG). 2- Blood pressure (mm Hg) using Sphygmomanometer.
Time Frame: Four weeks
1- Hart Rate (HR) (bpm) using Electro Cardiac Graphic (ECG). 2- Blood pressure (mm Hg) using 1-Hart Rate (HR) using Electro Cardiac Graphic (ECG). 2- Blood pressure using Sphygmomanometer.
Four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3- Range of Motion (ROM) (in degrees) of the cervical spine using Electro-Goniometer. 4- the pain using Visual Analogue Scale (VAS) from (0-10)
Time Frame: 4 Weeks
3- Range of Motion (ROM) (in degrees) of the cervical spine using Electro-Goniometer. 4- the pain using Visual Analogue Scale (VAS) from ( 0-10)
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2024

Primary Completion (Estimated)

May 20, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

February 10, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Jerash University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After publication

IPD Sharing Time Frame

After publication

IPD Sharing Access Criteria

Not yet

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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