Effect of Laser Puncture on Liver Enzymes Post Burn

Burns Clinical Trial

Official title:

Effect of Laser Puncture on Liver Enzymes Post Burn

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05728450
• Other study ID #: P.T.REC/012/004203
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 19, 2023
• Est. completion date: April 2023

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• Light amplification by stimulated emission of radiation (LASER)
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EFFECT OF LASER PUNCTURE ON LIVER ENZYMES POST BURN.	liver enzymes level (AST and ALT enzymes)	one month