Effect of Laser Puncture on Liver Enzymes Post Burn

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05728450

Collaborator

(none)

Enrollment

Arms

1.3

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Burns	Device: Light amplification by stimulated emission of radiation (LASER)	N/A

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.

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.
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Effect of Laser Puncture on Liver Enzymes Post Burn

Anticipated Study Start Date :

Feb 19, 2023

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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.

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

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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%.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aya Gamal Fawzy El-Sayed, Lecturer of physical therapy of surgery, Cairo University

ClinicalTrials.gov Identifier:

NCT05728450

Other Study ID Numbers:

P.T.REC/012/004203

First Posted:

Feb 15, 2023

Last Update Posted:

Feb 15, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Burns

Study Results

No Results Posted as of Feb 15, 2023