BurnsNCT05728450
Effect of Laser Puncture on Liver Enzymes Post Burn
A study testing Light amplification by stimulated emission of radiation (LASER) in people with Burns, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Burns
- What is being tested?
- Light amplification by stimulated emission of radiation (LASER)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Feb 2023to 19 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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%.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
The anatomical locations of acupoints used:
- Zusanli (ST36) acupoint is located on the lateral side of the lower leg, one hands' breadth below the knee crease and one finger's breadth lateral to the shin bone.
- Tanyinjiao (SP6) acupoint is located on the inside of the lower leg, one hands' breadth above the prominence of the medial malleolus.
- Taichong (LR3) acupoint is located on the dorsum of the foot in the distal hollow at the junction of the first and second metatarsal bone.
- Yan-glingquan (GB34) acupoint is located below the outside of the knee, in a tender depression 1 body inch anterior and inferior to the head of the fibula.
- Ganshu (BL18) acupoint is located two forefingers width lateral to the lower border of the spinous process of the 9th thoracic vertebra.
- Zhongwan (RN12) acupoint is located on the anterior median line of the upper abdomen, proximal 5 fingers breadth above the belly button.
- Conditions
- Burns
- Being tested
- Light amplification by stimulated emission of radiation (LASER)
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light amplification by stimulated emission of radiation (LASER)Device
- 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
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 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. Receives: Device: Light amplification by stimulated emission of radiation (LASER) |
| Control group | No intervention | This group includes 15 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFECT OF LASER PUNCTURE ON LIVER ENZYMES POST BURN.
liver enzymes level (AST and ALT enzymes)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start19 Feb 2023
- Primary completion19 Mar 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal Fawzy El-Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728450
- Sponsor's protocol ID
- P.T.REC/012/004203
- Status last verified
- Aug 2025
- First submitted
- 19 Jan 2023
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Puncture on Liver Enzymes Post Burn
- ClinicalTrials.gov ID
- NCT05728450
- Acronym / sponsor ID
- P.T.REC/012/004203
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 19 Feb 2023 (actual)
- Primary completion
- 19 Mar 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
The anatomical locations of acupoints used:
- Zusanli (ST36) acupoint is located on the lateral side of the lower leg, one hands' breadth below the knee crease and one finger's breadth lateral to the shin bone.
- Tanyinjiao (SP6) acupoint is located on the inside of the lower leg, one hands' breadth above the prominence of the medial malleolus.
- Taichong (LR3) acupoint is located on the dorsum of the foot in the distal hollow at the junction of the first and second metatarsal bone.
- Yan-glingquan (GB34) acupoint is located below the outside of the knee, in a tender depression 1 body inch anterior and inferior to the head of the fibula.
- Ganshu (BL18) acupoint is located two forefingers width lateral to the lower border of the spinous process of the 9th thoracic vertebra.
- Zhongwan (RN12) acupoint is located on the anterior median line of the upper abdomen, proximal 5 fingers breadth above the belly button.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Light amplification by stimulated emission of radiation (LASER)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. |
| Control group | No intervention | –This group includes 15 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Study group |
Primary outcome
EFFECT OF LASER PUNCTURE ON LIVER ENZYMES POST BURN.
Time frame: one month
liver enzymes level (AST and ALT enzymes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light amplification by stimulated emission of radiation (LASER) in people with Burns, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFFECT OF LASER PUNCTURE ON LIVER ENZYMES POST BURN. (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.