IRCT | Evaluation the effect of high-power laser with two simultaneous wavelengths on weight and waist circumference in women with abdominal obesity (Pilot Study)

Protocol summary

Study aim: Determining the effect of high power laser with two simultaneous wavelengths on weight and abdominal circumference in woman with abdominal obesity
Design: Clinical trial with a control group with parallel groups, double blinded, phase 2, randomized on 40 participants will be conducted. randomized block method will be used for randomizing.
Settings and conduct: Intervention will be carried out with student at Dr Tahery`s Physiotherapy clinic in the form of 2 sessions per week up to 10 times. and study is double blinded.
Participants/Inclusion and exclusion criteria: The target population in this study is women between 25 and 50 years old who have abdominal obesity. The body mass index should be between 25 and 35, and they shouldn't be breastfeeding or menopausal. It is obvious that any of contraindications of high power laser such as malignancy, radiotherapy, having a pacemaker, ect ,will cause people to leave study. Also if the persona has a life- threatening disease in away that affects the results of study ; in consultation with a specialist doctor(project partner), she will be excluded from the study.
Intervention groups: The laser will be performed by a Novin high power laser device with a combined wavelength of 810 and 980 nm with at least 15 joules of energy per unit square area of the abdomen.the laser will be applied by holding a manual piece perpendicular to the abdomen and moving it from the top and left to the right and vice versa. The intervention will be conducted two days a week and up to 10 sessions in both groups. The control group will receive the laser on the abdomen in the same and similar conditions but with the laser off.
Main outcome variables: Weight- Abdominal circumference

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20250318065125N1

Registration date: 2025-07-25, 1404/05/03

Registration timing: prospective

Last update: 2025-07-25, 1404/05/03

Update count: 0
Registration date: 2025-07-25, 1404/05/03

Registrant information: Name

Neda Ghderi

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 31 3792 3071

Email address

nedaghpt@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2025-08-23, 1404/06/01
Expected recruitment end date: 2025-12-22, 1404/10/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Evaluation the effect of high-power laser with two simultaneous wavelengths on weight and waist circumference in women with abdominal obesity (Pilot Study)

Public title: Evaluating the effect of high power laser on weight and abdominal circumference
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Women aged between 25 and 50 years old The circumference of the abdomen should be greater than and equal to 80 cm In the last three months, they have not used any other method, be in diet or physical activity, or any other method to lose weight or reduce abdominal fat. Home pregnancy test should be negative. Having a body mass index between 25 to 35

Exclusion criteria:

Having any of the high power laser contra-indications including: pregnancy, malignancy, radiotherapy in the last 4 to 6 months, pacemaker, abdominal skin sensation disorders and abnormal sensitivity to light. Having a history of abdominal surgery or liposuction Breastfeeding Menopause Having tattoo, trauma or any damage of abdominal skin. Suffering from any serious diseases in the body systems that endangers the person`s health and has the possibility of interfering with the results of the current research
Age: From 25 years old to 50 years old
Gender: Female

Phase

2

Groups that have been masked

Participant
Investigator
Outcome assessor
Data analyser

Sample size

Target sample size: 40

Randomization (investigator's opinion)

Randomized

Randomization description

Randomization will be done by a random block method and by a person rather than the researcher and the evaluator in 2 groups of 20 people. in this study, we will have 10 blocks of four, in such a way that 2 people from the intervention group and 2 people from the control group will be randomly placed in each block of 4.

Blinding (investigator's opinion)

Double blinded

Blinding description

Planning for double- blinding will be such that the participants, the evaluator ,the person who performs the intervention (researcher) and the Data analyser will not be aware of the grouping method. participants know that they will be in 2 different groups but they will be completely unaware of the grouping and which group they are in. the researcher (student) is not aware of the process of evaluating the people of both groups and finally the evaluator will be unware of intervention and grouping process .

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Isfahan University of Medical Sciences

Street address

Hezar Jerib street, Isfahan University of Medical Sciences, ethic committee of university

City

Isfehan

Province

Isfehan

Postal code

81746-73461
Approval date: 2025-07-16, 1404/04/25
Ethics committee reference number: IR.MUI.REC.1404.023

Health conditions studied

1

Description of health condition studied: Abdominal obesity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: Abdominal circumference
Timepoint: Before the treatment , at the end of the fifth session, at the end of the tenth session and the end of one month follow up period
Method of measurement: Special Tape measure for measuring abdominal circumference

2

Description: Weight
Timepoint: Before the treatment , at the end of the fifth session, at the end of the tenth session and the end of one month follow up period.
Method of measurement: Digital Scale

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: High power laser- the high power laser device is from Novin Engineering -Medical Company and model 885G, its maximum output power is 15 watts and it emits 2 wavelengths of 810 & 980 nm simultaneously. the radiation time will be calculated based on the area of the abdominal area measured with a tape and according to the relevant formula.
Category: Treatment - Devices

2

Description: Control group:
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Dr. Navid Taheri's physiotherapy clinic

Full name of responsible person

Dr.Navid Taheri

Street address

1st floor, Jahan Soltan building,Mohtasham Kashani Ave, Hakim nezami street, Isfahan.

City

Isfehan

Province

Isfehan

Postal code

8175979666

Phone

+98 31 3131 3551

Email

n_Taheri@rehab.mui.ac.ir

1

Sponsor: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Dr Gholamreza Asgari

Street address

Hezar Jerib Street, IsfahanU nivercity of Medical sciences, research and technology institue

City

Isfehan

Province

Isfehan

Postal code

81746-73461

Phone

+98 31 3792 3060

Email

askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Esfahan University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Mojtaba Heshmatipour

Position

Instructor

Latest degree

Master

Other areas of specialty/work

Physiotherapy

Street address

Hezar Jerib Sreet, Isfehan Medical University, Rehabilitation Factuly , Physiotherapy group

City

Isfehan

Province

Isfehan

Postal code

73461-81746

Phone

+98 31 3792 5040

Email

heshmatipour@rehab.mi.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Mojtaba Hshmatipour

Position

Instructor

Latest degree

Master

Other areas of specialty/work

Physiotherapy

Street address

Hezar Jerib Street,Isfehan University of medical science , rehabilitation faculty, physical therapy group

City

Isfehan

Province

Isfehan

Postal code

81746-73461

Phone

+98 31 3792 5040

Email

Heshmatipour@rehab.mui.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Neda Ghaderi

Position

Senior Student of Physiotherapy

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

Hezar Jerib Street, Isfehan University of Medical Science, faculty of Rehabilitation

City

Isfehan

Province

Isfehan

Postal code

81746-73461

Phone

+98 31 3792 5204

Email

nedaghpt@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

Evaluation the effect of high-power laser with two simultaneous wavelengths on weight and waist circumference in women with abdominal obesity (Pilot Study)