NCT05728450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

February 19, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2023

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

28 days

First QC Date

January 19, 2023

Last Update Submit

August 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • EFFECT OF LASER PUNCTURE ON LIVER ENZYMES POST BURN.

    liver enzymes level (AST and ALT enzymes)

    one month

Study Arms (2)

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.

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.

Interventions

* 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

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: * 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy of surgery

Study Record Dates

First Submitted

January 19, 2023

First Posted

February 15, 2023

Study Start

February 19, 2023

Primary Completion

March 19, 2023

Study Completion

April 19, 2023

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations