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Effect of Laser Puncture on Liver Enzymes Post Burn

Primary Purpose

Burns

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Light amplification by stimulated emission of radiation (LASER)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The subject selection will be according to the following criteria: Age ranges between 20-45 years. Male and female patients will participate in the study. All patients who have burned with BBSA about 30% to 50% with acupoints are unaffected. All patients enrolled on the study will have their informed consent. Exclusion Criteria: The potential participants will be excluded if they meet one of the following criteria: Burn at areas of acupuncture points. Lower limb amputation. History of liver diseases. Body mass index (BMI=kg/cm2)<30%.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Study group

    Control group

    Arm Description

    This group includes 15 burned patients who will receive laser puncture for one month (3 times/week) in addition to their physical therapy program (splinting, stretching ex. and ROM ex.) and medical treatment.

    This group includes 15 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment.

    Outcomes

    Primary Outcome Measures

    EFFECT OF LASER PUNCTURE ON LIVER ENZYMES POST BURN.
    liver enzymes level (AST and ALT enzymes)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 19, 2023
    Last Updated
    February 5, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05728450
    Brief Title
    Effect of Laser Puncture on Liver Enzymes Post Burn
    Official Title
    Effect of Laser Puncture on Liver Enzymes Post Burn
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 19, 2023 (Anticipated)
    Primary Completion Date
    March 2023 (Anticipated)
    Study Completion Date
    April 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Procedures of laser puncture: The treatment procedures will start after the patient's release from the intensive care unit. The patient will be in a comfortable position. The patient will wear protective eyeglasses. The points for the application of laser acupuncture will be cleaned before application. All patients in the study group will be submitted to an infrared diode laser, wavelength 808 nm, Pulse duration: 200 ms, Power density: 0.4 W/cm2, energy density 4 J/cm2. The plug of the laser unit will be inserted into the main current supply and the on/off switch will be switched on. The therapy form will be selected from the main menu and then the parameters will be set. Acupuncture detector (Pointer Excel II) will be used for the definite location of acupuncture points. Laser probe will be placed in contact with the skin perpendicular over the body acupoints Zusanli (ST36), Taichong (LR3), Tanyinjiao (SP6), Ganshu (BL18), Yan-glingquan (GB34) and Zhongwan (RN12) in both sides, with a duration of 90 sec for each point three times per week for a month.
    Detailed Description
    Thirty patients with partial thickness burn with burned body surface area (BBSA) about 30% to 50% will participate in this study after their release from the intensive care unit. Their ages will be ranged from 20 to 45 years. The participants will be selected from Orabi hospital and randomly distributed into two equal groups. 1. Group A (Study group): This group includes 15 burned patients who will receive laser puncture for one month (3 times/week) in addition to their physical therapy program (splinting, stretching ex. and ROM ex.) and medical treatment. 1. Group B (Control group): This group includes 15 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment. Criteria for the patient selection: - Inclusion Criteria: The subject selection will be according to the following criteria: Age ranges between 20-45 years. Male and female patients will participate in the study. All patients who have burned with BBSA about 30% to 50% with acupoints are unaffected. All patients enrolled on the study will have their informed consent. Exclusion Criteria: The potential participants will be excluded if they meet one of the following criteria: Burn at areas of acupuncture points. Lower limb amputation. History of liver diseases. Body mass index (BMI=kg/cm2)<30%. Procedures of laser puncture: The treatment procedures will start after the patient's release from the intensive care unit. The patient will be in a comfortable position. The patient will wear protective eyeglasses. The points for the application of laser acupuncture will be cleaned before application. All patients in the study group will be submitted to an infrared diode laser, wavelength 808 nm, Pulse duration: 200 ms, Power density: 0.4 W/cm2, energy density 4 J/cm2. The plug of the laser unit will be inserted into the main current supply and the on/off switch will be switched on. The therapy form will be selected from the main menu and then the parameters will be set. Acupuncture detector (Pointer Excel II) will be used for the definite location of acupuncture points. Laser probe will be placed in contact with the skin perpendicular over the body acupoints Zusanli (ST36), Taichong (LR3), Tanyinjiao (SP6), Ganshu (BL18), Yan-glingquan (GB34) and Zhongwan (RN12) in both sides, with a duration of 90 sec for each point three times per week for a month.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burns

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The points for applying laser acupuncture will be cleaned before application. All patients in the study group will be submitted to an infrared diode laser, wavelength 808 nm, Pulse duration: 200 ms, Power density: 0.4 W/cm2, energy density 4 J/cm2 (Chow, 2001). The plug of the laser unit will be inserted into the main current supply and the on/off switch will be switched on. The therapy form will be selected from the main menu and then the parameters will be set. Acupuncture detector (Pointer Excel II) will be used for the actual location of acupuncture points.
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    This group includes 15 burned patients who will receive laser puncture for one month (3 times/week) in addition to their physical therapy program (splinting, stretching ex. and ROM ex.) and medical treatment.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    This group includes 15 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment.
    Intervention Type
    Device
    Intervention Name(s)
    Light amplification by stimulated emission of radiation (LASER)
    Intervention Description
    The points for application of laser acupuncture will be cleaned before application. All patients in the study group will be submitted to infrared diode laser, wavelength 808 nm, Pulse duration: 200 ms, Power density: 0.4 W/cm2, energy density 4 J/cm2 (Chow, 2001). The plug of the laser unit will inserted into the main current supply and on/off switch will be switched on. The therapy form will be selected from the main menu and then the parameters will be set. Acupuncture detector (Pointer Excel II) will be used for definite location of acupuncture points
    Primary Outcome Measure Information:
    Title
    EFFECT OF LASER PUNCTURE ON LIVER ENZYMES POST BURN.
    Description
    liver enzymes level (AST and ALT enzymes)
    Time Frame
    one month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The subject selection will be according to the following criteria: Age ranges between 20-45 years. Male and female patients will participate in the study. All patients who have burned with BBSA about 30% to 50% with acupoints are unaffected. All patients enrolled on the study will have their informed consent. Exclusion Criteria: The potential participants will be excluded if they meet one of the following criteria: Burn at areas of acupuncture points. Lower limb amputation. History of liver diseases. Body mass index (BMI=kg/cm2)<30%.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Laser Puncture on Liver Enzymes Post Burn

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