Determining the effect of high-intensity laser therapy on knee osteoarthritis
Design
The randomized, single-blinded clinical trial, with parallel groups, Phase 3 on 50 patients
Settings and conduct
In this randomized single-blinded clinical trial study, 50 patients with osteoarthritis of the knee will be included in study and randomly divided into 2 groups. One group will receive standard routine treatment and the other group will receive high-intensity laser treatment. Then the degree of disability and pain intensity of patients will be compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients with osteoarthritis of the knee (Step 2 or 3 based on the Kellgren and Lawrence criteria), in the age category 40 to 70 years, and consent to participate in the study. Exclusion criteria included having rheumatic diseases, diabetes and systemic inflammatory diseases, bursite anserina, knee osteoarthritis with dominant lateral involvement of the knee, injection of hyaluronic acid and glucosamine compounds during the last 6 months, corticosteroid injections over the past six weeks, tumor malignancies and the presence of any contraindications for laser treatment.
Intervention groups
Control group: Patients in this group will be taught isometric exercises to strengthen the quadriceps muscles with repetitions three times a day, 10 times each time. Meloxicam 15 mg daily, one tablet daily for two weeks, and topical Rahamin ointment three times a day are applied topically to the affected knee.
Intervention group: In this group, in addition to the treatments prescribed in the control group, patients will be treated with HILI with a high-intensity laser device (model LUMIX C.P.S 6 watts made in Italy). The course will include 6 sessions of treatment three times a week for two weeks using a powerful laser.
Main outcome variables
Disability; Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220214054022N1
Registration date:2022-04-18, 1401/01/29
Registration timing:prospective
Last update:2022-04-18, 1401/01/29
Update count:0
Registration date
2022-04-18, 1401/01/29
Registrant information
Name
Mozhgan Aghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
maghaei@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-19, 1401/01/30
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the efficacy of high-intensity laser therapy on knee osteoarthritis
Public title
The effect of high-intensity laser therapy on knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with knee osteoarthritis (stage 2 or 3)
Age category 40 to 70 years
Satisfaction to participate in the study
Exclusion criteria:
Having rheumatic diseases, diabetes and systemic inflammatory diseases
bursite anserina
Knee osteoarthritis with predominant lateral involvement of the knee
Injection of hyaluronic acid and glucosamine compounds during the last 6 months
Corticosteroid injections over the past six weeks6
Having tumor malignancies
Existence of any contraindications for laser treatment
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The method is permuted block randomization. In this way, first using online software (sealed envelope), a sequence of random numbers will be created and by the same software, the generated numbers will be divided into 5 blocks of 10. Which is an equal number in each block will be 5 items from the intervention group and 5 items from the control group. So by doing each block, 5 patients (equally) will be assigned to each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to high-intensity laser therapy in one group, the Care provider is aware of the type of intervention in each of the two groups. But the patient is not aware of the different nature of the intervention in the two groups. In addition to the Outcome assessor, the statistical analyst will have no information about the type of intervention in each group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2022-02-13, 1400/11/24
Ethics committee reference number
IR.MUI.MED.REC.1400.799
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 treatment, immediately and three months after the last treatment session
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Disability
Timepoint
Before treatment, immediately and three months after the last treatment session
Method of measurement
the Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Intervention groups
1
Description
Control group: Patients in this group will be taught isometric exercises to strengthen the quadriceps muscle with repetitions three times a day, 10 times each time. Meloxicam 15 mg daily, one tablet daily for two weeks, and topical ointment Rahamin three times a day topically applied on the affected knee.
Category
N/A
2
Description
Intervention group: In this group, in addition to the treatments prescribed in the control group, patients will be treated with high-intensity laser irradiation with a high-intensity laser device (model LUMIX C.P.S 6 watts made in Italy). The course will include 6 sessions of treatment three times a week for two weeks using a powerful laser.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Parisa Taheri
Street address
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospital, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
Prs_taheri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Parisa Taheri
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospital, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
Prs_taheri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parisa Taheri
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospital, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
Prs_taheri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mozghan Aghaei
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospital, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
maghaei@resident.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD