Protocol summary
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Study aim
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Comparison of the effect of electric neurocutaneous stimulation and common treatment on inflammation in people with burns.
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Design
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A controlled, randomized, single-blind, randomized, phase 2 clinical trial on 36 patients. The rand function of Excel software was used for randomization.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240107060644N1
Registration date:
2024-02-11, 1402/11/22
Registration timing:
registered_while_recruiting
Last update:
2024-05-18, 1403/02/29
Update count:
1
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Registration date
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2024-02-11, 1402/11/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-01-24, 1402/11/04
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Expected recruitment end date
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2024-05-17, 1403/02/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the effect of transcutaneous electrical nerve stimulation and common intervention on the inflammation in people with burn : a randomised control trial study
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Public title
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Comparing the effect of transcutaneous electrical nerve stimulation and common intervention on the inflammation in people with burn : a randomised control trial study
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
32
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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People are randomly divided into two combined groups (electrical stimulation with drugs) and drug treatment alone.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-12-16, 1402/09/25
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Ethics committee reference number
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IR.AJUMS.REC.1402.480
Health conditions studied
1
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Description of health condition studied
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Thermal burn
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ICD-10 code
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T22
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ICD-10 code description
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Burn and corrosion of shoulder and upper limb, except wrist and hand
2
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Description of health condition studied
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Thermal burn
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ICD-10 code
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T23
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ICD-10 code description
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Burn and corrosion of wrist and hand
3
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Description of health condition studied
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Thermal burn
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ICD-10 code
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T24
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ICD-10 code description
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Burn and corrosion of lower limb, except ankle and foot
4
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Description of health condition studied
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burn disease
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ICD-10 code
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T25
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ICD-10 code description
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Burn and corrosion of ankle and foot
Primary outcomes
1
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Description
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C-reactive protein
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Timepoint
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Before the intervention and 24 and 48 hours after the end of the intervention
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Method of measurement
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Cell counter
2
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Description
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Albumin
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Timepoint
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Before the intervention and 24 and 48 hours after the end of the intervention
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Method of measurement
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Cell counter
3
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Description
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Pain
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Timepoint
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Before the intervention and 24 and 48 hours after the end of the intervention
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Method of measurement
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Visual Analogue Scale
Secondary outcomes
1
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Description
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Sleep quality
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Timepoint
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Before the intervention and 48 and 72 hours after the intervention
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Method of measurement
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Chen et al.'s sleep quality questionnaire
2
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Description
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Pain-related feelings and thoughts score
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Timepoint
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Before the intervention and 48 and 72 hours after the intervention
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Method of measurement
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Pain catastrophizing questionnaire
3
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Description
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Fear of movement score
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Timepoint
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Before the intervention and 48 and 72 hours after the intervention
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Method of measurement
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Tampa Scale Kinesiophobia questionnaire
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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Control group:16 participants in this group receive only common drugs.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Information on primary outcomes and secondary outcomes will be shared.
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When the data will become available and for how long
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6 months after the results are published
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To whom data/document is available
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Researchers working in universities of medical sciences
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Under which criteria data/document could be used
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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
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From where data/document is obtainable
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E-mail to the corresponding author of the article after publication
Email address of the respondent: nedaoraki@yahoo.com
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What processes are involved for a request to access data/document
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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.
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Comments
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