Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05728450
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-15
First Post:
2023-01-19
Brief Title:
Effect of Laser Puncture on Liver Enzymes Post Burn
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Effect of Laser Puncture on Liver Enzymes Post Burn
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Procedures of laser puncture
The treatment procedures will start after the patients 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 04 Wcm2 energy density 4 Jcm2
The plug of the laser unit will be inserted into the main current supply and the onoff 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
The treatment procedures will start after the patients 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 04 Wcm2 energy density 4 Jcm2
The plug of the laser unit will be inserted into the main current supply and the onoff 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 timesweek 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 BMIkgcm230
Procedures of laser puncture
The treatment procedures will start after the patients 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 04 Wcm2 energy density 4 Jcm2
The plug of the laser unit will be inserted into the main current supply and the onoff 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
1 Group A Study group This group includes 15 burned patients who will receive laser puncture for one month 3 timesweek 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 BMIkgcm230
Procedures of laser puncture
The treatment procedures will start after the patients 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 04 Wcm2 energy density 4 Jcm2
The plug of the laser unit will be inserted into the main current supply and the onoff 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None