Comparing the effect of transcutaneous electrical nerve stimulation and common intervention on the inflammation in people with burn : a randomised control trial study
Comparison of the effect of electric neurocutaneous stimulation and common treatment on inflammation in people with burns.
Design
A controlled, randomized, single-blind, randomized, phase 2 clinical trial on 36 patients. The rand function of Excel software was used for randomization.
Settings and conduct
A randomized trial is conducted with 32 burn patients hospitalized in Ahvaz accident and burn hospital. People are randomly divided into two combined groups (electrical stimulation with drugs) and drug treatment alone. The study will be a blind strain.
Participants/Inclusion and exclusion criteria
Entry criteria: people between 18 and 60 years old, the occurrence of burns in the first 24 hours, people with second and third degree burns with a burn level of less than 50%, alert people with the ability to respond.
Exclusion criteria: people with inhalation burns, patients under mechanical ventilation, pregnant women, people with psychiatric problems, unwillingness of the individual to participate in the study
Intervention groups
Intervention group: 16 participants in this group receive electrical stimulation in addition to the common treatment, which includes applying electrical stimulation to the skin near the burn area. TENS parameters, such as frequency, intensity and duration, are predetermined based on previous research. The electrodes are placed 2 cm from the burn area.
Main outcome variables
The primary outcome measure is the change in CRP/ALB ratio from the beginning to the end of the intervention period. Secondary outcome measures included pain levels, wound healing time.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240107060644N1
Registration date:2024-02-11, 1402/11/22
Registration timing:registered_while_recruiting
Last update:2024-02-11, 1402/11/22
Update count:1
Registration date
2024-02-11, 1402/11/22
Registrant information
Name
Mojtaba Aghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5366 5835
Email address
mojtabaaghaei745@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-24, 1402/11/04
Expected recruitment end date
2024-05-17, 1403/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of transcutaneous electrical nerve stimulation and common intervention on the inflammation in people with burn : a randomised control trial study
Public title
Comparing the effect of transcutaneous electrical nerve stimulation and common intervention on the inflammation in people with burn : a randomised control trial study
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
People between 18 and 60 years old
The occurrence of burns in the first 24 hours
People with second and third degree burns with a burn level of less than 50%
Alert people with the ability to respond
Exclusion criteria:
People with inhalation burns
Patients on mechanical ventilation
Pregnant women
People with psychiatric problems
People with psychiatric problems, pre-existing liver disease such as liver cirrhosis or hepatitis
History of inflammatory diseases such as osteoarthritis and inflammatory bowel disease, or conditions that they affect the amount of CRP and Albumin, such as acute pancreatitis, myocardial infarction, acute infection, malnutrition and nephrosis, burns with trauma or organ failure,
unwillingness of the individual to participate in the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
People are randomly divided into two combined groups (electrical stimulation with drugs) and drug treatment alone.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be a blind strain so that the evaluator of laboratory results and pain measurement and hospitalization time will not be aware of the type of groups. Before entering the study, informed consent will be obtained from the participants.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jundishapur Ahvaz University University of Medical Sciences
Street address
Azadegan St. in front of Moin Park, Shahadai One Hostel
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-12-16, 1402/09/25
Ethics committee reference number
IR.AJAMS.REC.1402.480
Health conditions studied
1
Description of health condition studied
Thermal burn
ICD-10 code
T22
ICD-10 code description
Burn and corrosion of shoulder and upper limb, except wrist and hand
2
Description of health condition studied
Thermal burn
ICD-10 code
T23
ICD-10 code description
Burn and corrosion of wrist and hand
3
Description of health condition studied
Thermal burn
ICD-10 code
T24
ICD-10 code description
Burn and corrosion of lower limb, except ankle and foot
4
Description of health condition studied
burn disease
ICD-10 code
T25
ICD-10 code description
Burn and corrosion of ankle and foot
Primary outcomes
1
Description
C-reactive protein
Timepoint
Before the intervention and 24 and 48 hours after the end of the intervention
Method of measurement
Cell counter
2
Description
Albumin
Timepoint
Before the intervention and 24 and 48 hours after the end of the intervention
Method of measurement
Cell counter
3
Description
Pain
Timepoint
Before the intervention and 24 and 48 hours after the end of the intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Sleep quality
Timepoint
Before the intervention and 48 and 72 hours after the intervention
Method of measurement
Chen et al.'s sleep quality questionnaire
2
Description
Pain-related feelings and thoughts score
Timepoint
Before the intervention and 48 and 72 hours after the intervention
Method of measurement
Pain catastrophizing questionnaire
3
Description
Fear of movement score
Timepoint
Before the intervention and 48 and 72 hours after the intervention
Method of measurement
Tampa Scale Kinesiophobia questionnaire
Intervention groups
1
Description
Intervention group: In addition to conventional treatment, participants in this group also receive electrical stimulation, which involves applying electrical stimulation to the skin near the burn area. TENS parameters, such as frequency, intensity and duration, are predetermined based on previous research. The electrodes are placed 2 cm from the burn area. Then electric current is applied with predetermined parameters (frequency 100 Hz, deviation 120 microseconds, duration of current application 30 minutes and current intensity up to the patient's tolerance threshold). The current is applied from the first day after the burn to three days after the burn, twice a day in the morning and afternoon (a total of 6 intervention times). Along with electrical stimulation treatment, routine hospital drug therapy is used.
Category
Rehabilitation
2
Description
Control group:16 participants in this group receive only common drugs.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital in Ahvaz
Full name of responsible person
Mohammad Mehdi Abolhasani
Street address
Azadegan St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 31 5366 5835
Email
mojtabaaghaei745@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Orakifar
Street address
Ahvaz Rehabilitation Faculty
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 31 5366 5835
Email
mojtabaaghaei745@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Orakifar
Position
Assistant Professor of Physiotherapy,Department of Physiotherapy, School of Rehabilitation Sciences,
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Ahvaz Rehabilitation Faculty
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3101
Email
Nadaoraki@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Abolhasani
Position
Master of Physiotherapy, Ahvaz University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Azadegan St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3101
Email
mahdiabolhasani.20@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojtaba Aghaei
Position
Master of Hematology, Ahvaz University of Medical Sciences.
Latest degree
Master
Other areas of specialty/work
Hematology
Street address
Azadegan Street, Shahada One Hostel
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3101
Email
mojtabaaghaei745@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
Information on primary outcomes and secondary outcomes will be shared.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers working in universities of medical sciences
Under which criteria data/document could be used
Using data to apply them in systematic and meta-analytical review studies
Necessary condition for submission: The applicant must be a researcher in the fields of medical sciences
From where data/document is obtainable
E-mail to the corresponding author of the article after publication
Email address of the respondent: nedaoraki@yahoo.com
What processes are involved for a request to access data/document
The data will reach the requester within a week after sending an email to the author responsible for the article and stating the purpose of using the data and also having the necessary conditions.