NCT06309849

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 20, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

February 10, 2024

Last Update Submit

April 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 1-Hart Rate (HR) (bpm) using Electro Cardiac Graphic (ECG). 2- Blood pressure (mm Hg) using Sphygmomanometer.

    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 Outcomes (1)

  • 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

Study Arms (2)

Efficacy of Physical Therapy Intervention in Cervical Angina Patients

EXPERIMENTAL

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)

know the effect of Physical Therapy Intervention in Cervical Angina Patients

PLACEBO COMPARATOR

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)

Interventions

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.

Also known as: 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,
Efficacy of Physical Therapy Intervention in Cervical Angina Patientsknow the effect of Physical Therapy Intervention in Cervical Angina Patients

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • cervical spondylosis, cervical disc, cervical instability

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chien JT, Hsieh MH, Yang CC, Chen IH, Lee RP. Anterior Cervical Discectomy and Fusion Versus Conservative Treatment for Cervical Angina Conservative Treatment. Clin Spine Surg. 2021 Nov 1;34(9):E514-E521. doi: 10.1097/BSD.0000000000001178.

MeSH Terms

Conditions

Radiculopathy

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
includes 30 participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Department of Physiotherapy for Cardiovascular/Respiratory and Geriatrics

Study Record Dates

First Submitted

February 10, 2024

First Posted

March 13, 2024

Study Start

April 20, 2024

Primary Completion

May 20, 2024

Study Completion

June 1, 2024

Last Updated

April 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

After publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After publication
Access Criteria
Not yet