The effect of percutaneous electrical nerve stimulation on the respiratory outcomes of patients with Covid-19 with moderate pulmonary involvement: A clinical trial
Determining the effect of percutaneous electrical nerve stimulation on respiratory outcomes in patients with Covid-19
Design
A clinical trial with a control group, with parallel groups, three-way, randomized, on 120 patients. For randomization, the 4-block method was used using software.
Settings and conduct
Participants in the study are selected from all patients in the wards of Imam Hossein Hospital in Shahroud. After random allocation of patients with two intervention and control groups, the intervention is performed in such a way that two plastic electrodes of 5 × 5 cm and adhesive are placed on both sides of the spinal appendage of the 7-neck vertebra; The electrodes are connected to the device and will be set for 45 minutes. In the case of the control group, the electrodes of the device are connected to the non-respiratory acupuncture points (anterior of the chest) and the current is established in the same way. Participants, data collectors and statistical analysts were also blinded to the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Covid-19 with moderate pulmonary involvement
Non-entry or exclusion criteria: Addiction, heart disease, liver, respiratory, kidney and advanced cancer, history of allergies and skin lesions and obesity and prohibition to be in a semi-sitting position
Intervention groups
Participants in the study are selected from all patients in the wards of Imam Hossein Hospital in Shahroud. After random assignment of patients with two intervention and control groups, the intervention is performed in such a way that two electrodes are placed on both sides of the 7-neck vertebral appendage and in the control group, the electrodes of the device on acupuncture points not related to breathing (anterior to the chest) is connected and flow is established.
Main outcome variables
Respiratory consequences
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210406050871N1
Registration date:2021-04-25, 1400/02/05
Registration timing:prospective
Last update:2021-04-25, 1400/02/05
Update count:1
Registration date
2021-04-25, 1400/02/05
Registrant information
Name
Amin Shahdad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3234 2901
Email address
amin.shahdad2019@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-30, 1400/02/10
Expected recruitment end date
2021-08-01, 1400/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of percutaneous electrical nerve stimulation on the respiratory outcomes of patients with Covid-19 with moderate pulmonary involvement: A clinical trial
Public title
The effect of percutaneous electrical nerve stimulation on the respiratory outcomes of patients with Covid-19 with moderate pulmonary involvement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of Covid-19 diagnosis based on PCR test results or CT Scan findings (Ground Glass view) by physician
Age over 18 and under 70 years
Use the same treatment protocol for patients
Existence of moderate pulmonary involvement (SpO2 between 90 to 93% and pulmonary involvement less than 50%) and the patient being in the second phase of Covid-19 disease according to the guideline of the Ministry of Health
Exclusion criteria:
Drug addiction
Cigarette addiction
Advanced metastatic cancer
Congestive heart failure (grades 3 and 4)
Kidney failure requires dialysis
History of mechanical ventilation before intervention
Existence of cardiac pacemaker
Cardiac conduction disorders
History of allergies and skin sensitivities in the area of the electrodes
The presence of a skin lesion in the area where the electrodes are placed
Hospitalized patients with other clinical manifestations of Covid-19 and no pulmonary involvement
Continuous use of bronchodilators
Having liver failure
Moderate to severe scoliosis
Obesity (BMI above 35)
Psychological illnesses lead to lack of patient cooperation
Cerebrovascular disorders
Having COPD
Having uncontrolled diabetes
Inability and prohibition to be in a semi-sitting position for any reason
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The 4-block block randomization method is used to create a random allocation sequence in this study because the participants gradually enter the study and also the number of assignments to each group is equal.
In this research, the random allocation sequence is obtained by the methodology consultant with the software.
After creating a random sequence, 112 opaque envelopes with wrappers are prepared and each random sequence is recorded on a card and placed inside the envelopes and closed. In order to maintain the sequence and to prevent disruption, the envelopes will be numbered and placed in a box.
Eligible participants will be registered by the principal investigator in the order of their arrival, and an envelope will be opened in the order in which the person enters the study, one of the envelopes will be opened, and thus his / her assigned group will be revealed. Individuals will be placed equally in each group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The present study is three-blind and in addition to the participants, the data collector (outcome assessor) and the statistical analyst are not aware of the allocation of groups.
The data collector who is involved in collecting and recording information such as respiration rate, pulse, oxygen saturation, etc., or in completing questionnaires will be unaware of the group of individuals.
The analyst will also be unaware of the group of people.
It should be noted that the physiotherapist who is responsible for the intervention and is known as the caregiver, by contacting the research colleague who has the sequence, becomes aware of the group to which each person is assigned and performs the intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
7th Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
3616718473
Approval date
2021-04-11, 1400/01/22
Ethics committee reference number
IR.SHMU.REC.1400.008
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Coronavirus disease (COVID-19)
Primary outcomes
1
Description
Dyspnea Severity
Timepoint
Daily for up to 4 days
Method of measurement
Dyspnea Severity Visual Analogue Scale
2
Description
Dyspnea Quality
Timepoint
Daily for up to 4 days
Method of measurement
Modified Medical Research Council (mMRC) Dyspnea Scale
3
Description
Quality of dyspnea and respiratory effort
Timepoint
Daily for up to 4 days
Method of measurement
6-item questionnaire with the need to answer yes / no related to the respiratory effort of patients with Covid-19
4
Description
Requires mechanical ventilation
Timepoint
From the first day until the patient is hospitalized
Method of measurement
Mechanical Ventilation Data Collection Checklist
5
Description
Patient respiration rate
Timepoint
Daily for up to 4 days
Method of measurement
Count by the researcher in one full minute
6
Description
Patient pulse rate
Timepoint
Daily for up to 4 days
Method of measurement
Count by the researcher in one full minute
7
Description
Percentage of arterial blood oxygen saturation
Timepoint
Daily for up to 4 days
Method of measurement
Finger pulse oximeter device and monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: is performed by a researcher who does not know the assignment of groups under the supervision of an Acu-TENS trained physiotherapist for the intervention group in such a way that the patient is in a sitting or semi-sitting position and by re-controlling the skin of the area for lesions, Two plastic electrodes 5 × 5 cm and sticky are placed on both sides of the spine appendage of 7 cervical vertebrae; The electrodes are connected to NOVIN701P PLUS-STIMULATOR device made in Iran and serial number AX212088 and the frequency is set to 4 Hz and the pulse is set to 200 MICROSEC with a duration of 45 minutes.
Category
Treatment - Devices
2
Description
Control group: performed by a researcher who does not know the assignment of groups under the supervision of a trained Acu-TENS physiotherapist ineffective for the control group in such a way that the patient is placed in a sitting or semi-sitting position and by re-controlling the skin of in view of the lesion, two plastic electrodes of 5 و 5 cm and adhesive are placed in an ineffective point for breathing, the front of the chest; The electrodes are connected to NOVIN701P PLUS-STIMULATOR device made in Iran and serial number AX212088 and the frequency is set to 4 Hz and the pulse is set to 200 MICROSEC with a duration of 45 minutes.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Mahboobeh Khajeh
Street address
7 thTir Square., Shahroud University of Medical Sciences
City
شاهرود
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5054
Email
m_khajeh@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamiyan
Street address
Haft Tir Square., Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5054
Email
pishgiri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mahboobeh Khajeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
7th Tir Square. Shahroud University of Medical Sciences
City
شاهرود
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5054
Email
m_khajeh@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mahboobeh Khajeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
7th Tir Square. Shahroud University of Medical Sciences
City
شاهرود
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5054
Email
m_khajeh@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Amin Shahdad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Azadi.
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3234 2901
Fax
Email
Amin.shahdad2019@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome, can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
If necessary, contact Dr. Mahboobeh Khajeh and if there is a reasonable justification for use in scientific purposes
From where data/document is obtainable
Dr. Mahboobeh Khajeh
Shahroud, 7thTir Square, Shahroud University of Medical Sciences;
School of Nursing and Midwifery
02332395054
m_khajeh@ymail.com
What processes are involved for a request to access data/document
By phone call or by email and registration of the request and stating the reason and purpose of the logical and approved up to two weeks