Clinical trial comparison of the effect of low level and high level laser therapy (Ga-Al-Ar) and exercise therapy on the function and the pain of knee osteoarthritis
The aim of this study is comparison the efficacy of gallium aluminum arsenide (Ga-Al-Ar) laser therapy (low level & high level) and exercise therapy on the function and pain of patients with grade 2 and 3 knee osteoarthritis. This study will be performed on 75 patients as a single center randomized of the phase 2-3 clinical trial and by simple randomized method (closed envelopes method and selecting color cards) in velayat hospital of Qazvin. Selected patients should have grade 2 and/or 3 osteoarthritis (OA). Kollgrn Lawreance system will be used to evaluate OA grading. The patients will be divided in to 3 groups; low level laser therapy (25 cases), high level laser therapy (25 cases) and exercise therapy (25 cases).The patients will be treated by laser therapy 3 times per week for 4 weeks (12 sessions). Outcome variable of knee pain intensity will be assessed before the treatment and during the first, second, third and forth weeks of treatment and also the first and forth weeks after the end of treatment by using laser and exercise therapies in each groups according to the visual analogue scales (VAS). Also, outcome variable of knee function will be assessed in a similar way according to the WOMAC questionnaire. The pain intensity will be assessed during the rest and activities.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011325994N1
Registration date:2016-03-10, 1394/12/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-10, 1394/12/20
Registrant information
Name
Mahnaz Abbasi
Name of organization / entity
Qazvin University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 28 3376 0620
Email address
mabasi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Qazvin University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparison of the effect of low level and high level laser therapy (Ga-Al-Ar) and exercise therapy on the function and the pain of knee osteoarthritis
Public title
comparison the effect of laser and exercise on the function and the pain of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age more than 50; patient with grade 2 and 3 osteoarthritis
Exclusion criteria: Other knee joint disorder; Hip and/or foot osteoarthritis; serious systematic illness; Corticosteroid and Hyaloronic acid non-injection in knee joint during the past 6 months; knee effusion; knee surgery.
Age
From 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethics Committee of the University of Medical Sciences
Street address
Shahid Bahonar Blvd.
City
Qazvin
Postal code
3419759811
Approval date
2012-06-19, 1391/03/30
Ethics committee reference number
5995/20/28
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17.9
ICD-10 code description
Gonarthrosis, unspecified
Primary outcomes
1
Description
knee pain intensity
Timepoint
The pain intensity before the treatment and the first, second, third and forth weeks and also the first and forth weeks after treatment by laser and exercise
Method of measurement
In all three groups based on the visual analogue scales (VAS)
2
Description
knee function
Timepoint
knee function before the treatment and the first, second, third and forth weeks and also the first and forth weeks after treatment by laser and exercise
Method of measurement
WOMAC questionnair
Secondary outcomes
empty
Intervention groups
1
Description
In first group, low level of laser(Ga-Al-Ar) 3 times per week for 4 weeks (12 sessions)
Category
Treatment - Other
2
Description
In second group, low level of laser(Ga-Al-Ar) 3 times per week for 4 weeks (12 sessions)
Category
Treatment - Other
3
Description
the third group will be taught isometric and isotonic strengthening and stretching exercises for quadriceps and hamstring muscles by training bulletin and face to face training.