The Comparison between effect of high intensity and low intensity laser therapy on pain, disability and joint effusion in patients with chronic knee osteoarthritis grade 1,2: A Randomized Clinical Trial
The Comparison between effect of high intensity and low intensity laser therapy on pain, disability and joint effusion in patients with chronic knee osteoarthritis grade 1,2
Design
A randomized, controlled, blinded, clinical trial with a parallel group design of 71 patients
Settings and conduct
The effects of laser therapy in patients with osteoarthritis. All procedures will be performed in khatam hispital, zahedan university of medical sciences. The patients will be in 3 groups double blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 40-60 yrs; Osteoarthritis grade 1 or 2. non-iclusion criteria: Rheumatoid arthritis; complete tear anterior cruciate ligament or menisci; Hyalgan or corticosteroids injection in last 6 months; Grade 3 and 4 osteoarthritis
Intervention groups
1-Control group: 1) The Infrared bulb is positioned at a distance of 50 cm from the knee. 2- Transcutaneous electrical nerve stimulation(TENS) 3- Exercise for strengthening,stretching,rane of motion muscle should include 6 exercises . 2- Low level laser therapy Treatments in control group and low level laser therapy 3- High power laser therapy Treatments in control group and high power laser therapy
Main outcome variables
Supra patella effusion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516034003N8
Registration date:2019-09-15, 1398/06/24
Registration timing:registered_while_recruiting
Last update:2019-09-15, 1398/06/24
Update count:0
Registration date
2019-09-15, 1398/06/24
Registrant information
Name
Kamran Ezzati
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3369 0099
Email address
kamranezzati@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-08, 1398/04/17
Expected recruitment end date
2019-10-09, 1398/07/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison between effect of high intensity and low intensity laser therapy on pain, disability and joint effusion in patients with chronic knee osteoarthritis grade 1,2: A Randomized Clinical Trial
Public title
The effects of laser therapy on symptoms of patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Radiologic signs of grade 1 and 2 Kellgren-Lawrence: Decrease of joint space and existence of osteophytes
Body mass index<40
Exclusion criteria:
The patients with rheumatoid arthritis; malignancy; knee surgery; fracture; complete tear anterior cruciate ligament or menisci; athletics; neuropathy, hyalgan or corticosteroids injection in last 6 months.Physiotherapy in last month
Grade 3 and 4 Kellgren-Lawrence in radiologic examination
Local infection
Referral pain from lumbar or hip to knee
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
71
More than 1 sample in each individual
Number of samples in each individual:
2
One participant may have osteoarthritis in Both knees, and both knees are used in this study as sample.
Randomization (investigator's opinion)
Randomized
Randomization description
The grouping method will be stratified permuted block randomization . Equal number of patients from 3 groups will be matched based on age, Body mass index. So, 3 blocks of 10 people for 3 groups will be allocated. A software engineer at the ward will perform this method
Blinding (investigator's opinion)
Single blinded
Blinding description
Although routine physical therapy will be performed for all patients, they won`t know anything about laser therapy and the kind of it. So, the patients are blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of zahedan University of Medical Sciences
Street address
daneshgah blvd, dr hessabi square
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-07-07, 1398/04/16
Ethics committee reference number
IR.ZAUMS.REC.1398.140
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Unilateral primary osteoarthritis of knee
Primary outcomes
1
Description
Pain
Timepoint
Before intervention, After ten sessions treatments, one month follow-up
Method of measurement
Visual Analogue Scale
2
Description
Area of supra patella effusion
Timepoint
Before intervention, After ten sessions treatments, one month follow-up
Method of measurement
Using ultrasonography
3
Description
Thickness of supra patella effusion
Timepoint
Before intervention, After ten sessions treatments, one month follow-up
Method of measurement
Using ultrasonography
4
Description
Disability
Timepoint
Before intervention, After ten sessions treatments, one month follow-up
Method of measurement
WOMAC questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 1-Control group: Interventions in this group include: 1) Infrared therapy for 20 minutes: The Infrared bulb is positioned at a distance of 50 cm from the knee of the individuals. The patient will feel mild heat. 2- Treatment with transcutaneous electrical nerve stimulation(TENS) type brief for 20 minutes. The frequency used varies from 3 to 120 Hz, and the patient will feel the electrical current, along with the muscle vibrations about 20 minutes. 3- Exercise for strengthening,range of motion, stretching muscle should include 6 exercises.
Category
Rehabilitation
2
Description
Int Low level laser therapy: All interventions in control group with low level laser therapy: Laser therapy (laser med, Carci, brazil) with 905 nm wavelength, 12 joules, 50 mW on 10 points of the knee. Each point treatment time will be 912 seconds.
Category
Rehabilitation
3
Description
Intervention group: High power laser therapy: All interventions in control group with high power laser therapy: Laser therapy (High power laser,New Age , Italy) with 905 nm wavelength, 12 joules, 1.6W on all areas of the . Treatment time will be 300 seconds.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam hospital
Full name of responsible person
Fatemeh Ghiasi
Street address
Physiotherapy section, khatam hospital,jaam jam boulevard, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Fax
Email
khatamhospital_zah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Noor mohammad Bakhshani
Street address
Medical science campus,dr hesssabi square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Anahita Hasannejad
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
first dead end,tenth ferdowsi,azadegan square
City
Lahijan
Province
Guilan
Postal code
4414863164
Phone
+98 13 4234 2659
Email
anahita.hasannejad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
hasan namvar
Position
educator
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
rehabilitation campus,zahedan university of medical sciences,doctor hessabi