The effects of High Intensity Laser Therapy(HILT) in comparison with Intra Articular Hyaluronic Acid(IAHA) injection on the pain and function of knee ostoarthrosis
Comparison of two methods of treatment in knee arthritis patients
Design
A randomized, single-blinded trial. The method of sampling is randomized patients with grade 1 or 2 knee osteoarthritis referring to affiliated and independent medical centers of Iran University of Medical Sciences.
Settings and conduct
place: Iran University Medical Science,
Initially confirmation of knee arthritis by orthopedic surgeon and randomization of patients in three groups.
For the injection group, 4 injections of IAHA are administered weekly and routine physiotherapy will be performed simultaneously with injection.
For the HILT group, a weekly three times laser treatment with routine physiotherapy will be performed. For the placebo Laser Group, a weekly three times placebo Laser with routine physiotherapy will be performed. All groups are evaluated before, immediately after and one month after treatment.
Blind: The evaluator is blind to what each patient is in.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Individuals with knee arthritis with Grade 1 or 2 of kellgern-Lawrence classification.
Not having rheumatic diseases; rupture of the ligament or meniscus; history of fracture; hyalgeal injection; or physiotherapy within recent 6 months.
The absence of referral pain from the waist and pelvis
VAS 4 or more
WOMAC score 25 and above
Exclusion criteria :
lacking one of the Inclusion criteria
Unwillingness to continue the research for any reason
Intervention groups
Group 1: patients who are treated with IAHA and routine physiotherapy.
Group 2: patient who are treated with HILT and routine physiotherapy.
group 3: patients who are receiving placebo laser and routine physiotherapy.
Main outcome variables
number of VAS scale, number of stiffness from WOMAC sub scale, number of pain from WOMAC sub scale, number of function from WOMAC sub scale, amount of edema, degree of knee ROM
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140810018754N9
Registration date:2018-11-03, 1397/08/12
Registration timing:registered_while_recruiting
Last update:2018-11-03, 1397/08/12
Update count:0
Registration date
2018-11-03, 1397/08/12
Registrant information
Name
Javad Sarrafzadeh
Name of organization / entity
Iran University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
00982122228051-00982122227124
Email address
sarrafzadeh.j@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-15, 1397/06/24
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of High Intensity Laser Therapy(HILT) in comparison with Intra Articular Hyaluronic Acid(IAHA) injection on the pain and function of knee ostoarthrosis
Public title
The effects of high intensity laser therapy on knee ostoarthrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Grade 1 or 2 knee osteoarthritis according to the Kellgren-Lawrence classification
had a knee pain≥4 on the visual analog scale (VAS)
do not injection corticostroid or hyaluronic acid in last six mount
the gain 25 number in minimum condition from the WOMAC scale
BMI < 30
Exclusion criteria:
existence RA, malignancy, knee surgery, fracture, menisqe or ligament tearing, genu varum or valgum above 20 degree, referal pain from hip or lumbar region
doing physiotherapy in last six mount
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Unit of randomization: personal
Using the SPSS program
Blinding (investigator's opinion)
Single blinded
Blinding description
Examiner did not know that each simple present in witch group
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
5th floor, Iran University of Medical Sciences, Hemmat highway, between Sheikh Fazlollah Nuri and Chamran highways.
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-08-25, 1397/06/03
Ethics committee reference number
IR.IUMS.REC.1397.197
Health conditions studied
1
Description of health condition studied
Knee ostoarthrosis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
intensity of pain
Timepoint
before starting the first treatment session, after the end of treatment session and one mount after the last of treatment session
Method of measurement
Visual analog scale (VAS)
2
Description
function and quality of life
Timepoint
before starting the first treatment session, after the end of treatment session and one mount after the last of treatment session
Method of measurement
persian WOMAC scal
3
Description
rang of motion of knee FLX and EXT
Timepoint
before starting the first treatment session, after the end of treatment session and one mount after the last of treatment session
Method of measurement
KROM device (degree)
4
Description
amount of knee odema
Timepoint
before starting the first treatment session, after the end of treatment session and one mount after the last of treatment session
Method of measurement
tape measure according in CM
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: This group constitutes patients with knee arthrosis, on the basis of Kellgren- Lawrence classification grade 1 or 2, whom received weekly (more accurately, for times a week) hyaluronic acid injection. The patients are to be undergone physiotherapy simultaneous with their getting the injections. the physiotherapy treatment comprises 20-minute IF current , US applied continuous for 5 minutes with 1 W/cm2 intensity, IR for 15 minutes, as well as the exercise training. The physiotherapy treatment must be performed weekly (triple a week) for 10 sessions.
Category
Treatment - Other
2
Description
Intervention group 2: This group constitutes patients with knee arthrosis, on the basis of Kellgren- Lawrence classification grade 1 or 2, receiving physiotherapy treatment as well as High Intensity Laser Therapy(HILT) . the laser's treatment protocol in the first three sessions is as follows: duty cycle:50%, frequency: 5000 Hz, Power density2.04 W, Energy density 10 J/cm2, treatment duration: 3 minute, the approximate treatment area : 100cm2 round the knee and the total apleid energy is 1000 J. However, the laser's treatment protocol in the next seven sessions is as follows:Power density 4.09 W, Energy density 50 J/cm2, treatment duration: 7 minute, the approximate treatment area : 100cm2 round the knee, the total apleid energy is 5000 J. and the laser's wavelength is 980 nm. The physiography treatment of this group comprises, as does the invention group 1, 20-minute IF current , US applied continuous for 5 minutes with 1 W/cm2 intensity, IR for 15 minutes, as well as the exercise training. The physiotherapy treatment must be performed weekly (triple a week) for 10 sessions.
Category
Treatment - Other
3
Description
Control group: This group constitutes patients with knee arthrosis, on the basis of Kellgren- Lawrence classification grade 1 or 2, receiving physiotherapy treatment as well as placebo High Intensity Laser Therapy (HILT), that is to say, the treatment is performed in a similar manner as to intervention group 2 ,though the laser fluency is lacking. As was the case for intervention group 1 and 2, the physiography treatment of this group comprises 20-minute IF current , US applied continuous for 5 minutes with 1 W/cm2 intensity, as well as the exercise training. The physiotherapy treatment must be performed weekly (triple a week) for 10 sessions.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Yahiaeian Medical Education Center
Full name of responsible person
Abolfazl Baqerifard
Street address
Shafa Yahiaeian Medical Education Center, Mojahedine Eslam St, Baharestan Sqr.
City
Tehran
Province
Tehran
Postal code
354-14665
Phone
+98 21 3354 2001
Email
baqerifard.a@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Malakouti, Vice chancellor for research
Street address
5th Floor, Iran University of Medical Sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Web page address
http://vcr.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Javad Sarrafzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Madar squ., Mirdamad street.
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Email
sarrafzadeh.j@iums.ac.ir
Web page address
http://rehab.iums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Javad Sarrafzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Madar squ., Mirdamad street.
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Email
sarrafzadeh.j@iums.ac.ir
Web page address
http://rehab.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Javad Sarrafzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Madar squ., Mirdamad street.
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Email
sarrafzadeh.j@iums.ac.ir
Web page address
http://rehab.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data or results of the present study will be presented in an article or some articles that will be published after completing the study.
When the data will become available and for how long
After completing the present study and publishing the resulting article or articles.
To whom data/document is available
All researchers in the field of the present study.
Under which criteria data/document could be used
With the same goal as the present study and with mention of the present study as the reference. All intellectual property rights of the present study belongs to the Iran University of Medical Sciences.
From where data/document is obtainable
The corresponding author of the article or articles derived from this study.
What processes are involved for a request to access data/document
Written request from the author responsible for the present review after the publication of the resulting article or articles.