Determining and comparing the therapeutic effects of high-power and interstitial lasers in improving pain and function in patients with osteoarthritis.
Design
A randomized, parallel clinical trial study in 2025 on 60 patients with knee osteoarthritis who were randomly assigned to one of two intervention groups.
Settings and conduct
In this study, patients with knee osteoarthritis who refer to the physical medicine clinics of Isfahan University of Medical Sciences will be included in the study if they are eligible and will be randomly assigned to the intervention and control groups using a randomized block method.
Participants/Inclusion and exclusion criteria
Patients with inclusion criteria: 1) osteoarthritis according to the American College of Rheumatology criteria 2)osteoarthritis grade I or II according to the Kellgren-Lawrence grade 3) Total score of at least 25 on the (WOMAC) 4) Pain ≥4 on the (VAS) 5) Willingness to participate to the treatment plan
Intervention groups
group1: in the high-power laser group were treated in the following way: high-power laser was performed in 4 sessions, first 2 sessions per week and then one session per week with a diode laser with a power of 1 watt, a wavelength of 808 nanometers, an energy density of 60 J/CM2, at 5 points on the knee with a total of 300 joules. group2: intratissue laser group, under sterile conditions, an 18 gauge Winset needle is inserted from the medial side of the knee joint. Then, a sterile optical fiber specifically for intratissue lasers is inserted into the tissue through the needle. The optical fiber is connected to a low-power diode laser with a power of 0.25 watts wavelengths of 670, 808, and 450 nm. With a total energy of 15 joules (each wavelength 5 joules), laser sessions are performed in 4 sessions: 2 sessions in the first week and then one session per week.
Main outcome variables
pain, function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231203060255N4
Registration date:2025-07-18, 1404/04/27
Registration timing:registered_while_recruiting
Last update:2025-07-18, 1404/04/27
Update count:0
Registration date
2025-07-18, 1404/04/27
Registrant information
Name
Fateme Hoseinzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3233 0973
Email address
fatemehoseinzade@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-11, 1404/04/20
Expected recruitment end date
2025-09-23, 1404/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Interstitial Laser Therapy in Improving Pain and Function in Osteoarthritis
Public title
Investigating the effect of Interstitial Laser Therapy in Improving Pain and Function in Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Knee osteoarthritis according to the American College of Rheumatology criteria Knee osteoarthritis grade I or II according to the Kellgren-Lawrence grading Total score of at least 25 on the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) questionnaire(knee pain severity ≥4 on the visual analog scale (VAS) in the past 3 months Willingness to participate and adhere to the treatment plan.
Exclusion criteria:
Unwillingness to participate in the studyGrade 3 knee osteoarthritisSystemic diseases including uncontrolled diabetes, rheumatoid arthritis, cancer, etc.Skin lesions at the site of laser treatment, including wounds and any skin rash
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
How to select the sample: random sampling is done by consecutive non-probability sampling, and the number of samples is based on the calculation formula and the number of 30 people in each group, a total of 60 people (n=30). and random allocation ,the samples included in the study are allocated to 2 groups using SPSS software. In this way, 30 random numbers from 1 to 60 are created by Excel software, which are assigned to the first intervention group, and then the remaining 30 numbers are assigned to the second group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Research Ethics Committee of the "Alzahra Research Centers"
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Building No. 4, Research and Technology Vice-Chancellor
City
ISFAHAN
Province
Isfehan
Postal code
8174673461
Approval date
2025-05-06, 1404/02/16
Ethics committee reference number
IR.MUI.MED.REC.1404.066
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
pain
Timepoint
Before the intervention and after the end of the intervention, one month after the intervention and three months after the end of the intervention
Method of measurement
Visual Analogue Scale
2
Description
Patient function
Timepoint
Before the intervention and after the end of the intervention, one month after the intervention and three months after the end of the intervention
Method of measurement
(WOMAC) Western Ontario McMaster Universities Osteoarthritis Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the high-power laser group were treated in the following way: high-power laser was performed in 4 sessions, first 2 sessions per week and then one session per week with a diode laser by fisoiline company made in Italy with a power of 1 watt, a wavelength of 808 nanometers, an energy density of 60 J/CM2, at 5 points on the knee with a total of 300 joules
Category
Treatment - Devices
2
Description
Intervention group: Intervention group 2: In the intratissue laser group, it is performed in the following way: under sterile conditions, an 18 gauge Winset needle is inserted from the medial side of the knee joint. Then, a sterile optical fiber specifically for intratissue lasers is inserted into the tissue through the needle. The optical fiber is connected to a low-power diode laser with a power of 0.25 watts weber company made in Germany and wavelengths of 670, 808, and 450 nm. With a total energy of 15 joules (each wavelength 5 joules), laser sessions are performed in 4 sessions: 2 sessions in the first week and then one session per week.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Fateme Hoseinzade
Street address
Shahada Square, Ibn Sina St., Sanbulistan St., Amin Medical Education Center
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3112 2020
Email
fatemehoseinzade98@gamil.com
Web page address
https://amin.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Building No. 4, Hazar Jarib Street,Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Web page address
https://research.mui.ac.ir/fa
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
fateme hoseinzade
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hazar Jarib St., Isfahan University of Medical Sciences
City
isfahan
Province
Isfehan
Postal code
91746734461
Phone
+98 31 3668 0048
Email
fatemehoseinzade98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fateme Hoseinzade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hazar Jarib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
91746734461
Phone
+98 31 3668 0048
Email
Fatemehoseinzade98@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fateme Hoseinzade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hazar Jarib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Fatemehoseinzade98@gamil.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