The effect of low and high power laser therapy on pain,disability and range of motion in patients with knee osteoarthritis: a comparative clinical trial study
The main aim of this study is comparison between long terms and immediately effects of high and low power laser therapy on knee osteoarthritis symptoms. This study is a clinical trial that will be done on 50 patients with knee osteoarthritis who referred to physiotherapy clinics of Semnan University of Medical Sciences by physician. Volunteers informed about the experimental procedure and purpose of this study. Main inclusion criteria are osteoarthritis of the knee and main exclusion criteria include factors that affect knee pain. Subsequently, their written informed consent is obtained. The patients were randomly assigned to three groups: The patients were randomly assigned to three groups:
1-standard treatment with placebo laser
2-standard treatment with low power laser
3-standard treatment with high power laser groups.
In the low power laser group, a Gal-AL-AS diode laser device with a power output of 30 MW and a wavelength of 830 NM and in the high power laser group, a Gal-AL-AS diode laser device with a power output of 3.2 W and a wavelength of 910 NM will be used. In the placebo group, the same points and the similar duration will be applied while turned off the laser device. Standard treatment is Ultrasound, TENS current. Hot pack, Straight Leg Raising in supine position. They will be treated for ten session¸ 5 times weekly and in period of two weeks. Pain, disability, functional ability and ROM will be investigated before, immediately and 6 weeks after study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502224549N8
Registration date:2015-05-19, 1394/02/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-19, 1394/02/29
Registrant information
Name
Elham Fatemy
Name of organization / entity
Semnan University Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4180
Email address
fatemy@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Sciences
Expected recruitment start date
2015-04-19, 1394/01/30
Expected recruitment end date
2015-07-21, 1394/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low and high power laser therapy on pain,disability and range of motion in patients with knee osteoarthritis: a comparative clinical trial study
Public title
The effect of laser therapy on knee Osteoarthritis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1-Unconscious chronic unilateral knee Osteoarthritis that has an intensity of 1-3 on the radio graphs.
2- Having local pain in the knee region that was greater than 4 with regard to VAS.
3- Earn a minimum score of 25 regard to the WOMAC scale.
Exclusion criteria:
1- History of knee fracture, Knee tendons and ligaments injury, meniscus or knee surgery.
2- Rheumatoid arthritis.
3- Risk of bleeding.
4- Musculoskeletal disorders of hip and ankle.
5- Central and peripheral neuropathy.
6- History of physiotherapy in the last 6 months.
7- History of corticosteroid articular injection in the last 6 months.
8- Oral anti coagulation medication.
9- Unconscious patients.
10- Neoplasm.
11- Deep vein thrombosis.
12- Pacemaker.
13- Neurological deficits.
14- Severe Obesity.
Age
From 45 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Sampling is convenience and the volunteers are randomly allocated to three groups by lottery.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Kilometer 5, Damghan Road
City
Semnan
Postal code
Approval date
2015-03-17, 1393/12/26
Ethics committee reference number
584671.93
Health conditions studied
1
Description of health condition studied
Osteoarthritis of the knee joint
ICD-10 code
M19.0
ICD-10 code description
Primary Osteoarthritis of other joints
Primary outcomes
1
Description
pain
Timepoint
Before, immediately and 6 weeks after intervention
Method of measurement
Visual Analogue Scale(VAS) Questionnaire
2
Description
Range of motion
Timepoint
Before, immediately and 6 weeks after intervention
Method of measurement
Via the goniometry that show the range of motion with degree.
3
Description
Disability
Timepoint
Before, immediately and 6 weeks after intervention
Method of measurement
WOMAC Western Ontario Mac Master(WOMAC) Questionnaire
4
Description
Functional ability
Timepoint
Before, immediately and 6 weeks after intervention
Method of measurement
Via the “Two minutes walk test “ that determinate the distance walked with Meter.
Secondary outcomes
empty
Intervention groups
1
Description
In the low power laser group the treatment that applied is 1 MHZ continuous mode Ultrasound with duration of 5 MIN and intensity of 1 W.CM2, TENS current with frequency of 100 HZ and pulse duration of 0.05 MS and the time of treatment of 15 MIN. Hot pack, SLR in supine position and Gal-AL-AS diode laser device with a power output of 30 MW and a wavelength of 830 NM will be used.
Category
Rehabilitation
2
Description
In the placebo laser group the treatment that applied is 1 MHZ continuous mode Ultrasound with duration of 5 MIN and intensity of 1 W.CM2, TENS current with frequency of 100 HZ and pulse duration of 0.05 MS and the time of treatment of 15 MIN. Hot pack, SLR in supine position and A same laser device will be used while turned off the laser device.
Category
Rehabilitation
3
Description
In the high power laser group the treatment that applied is 1 MHZ continuous mode Ultrasound with duration of 5 MIN and intensity of 1 W.CM2, TENS current with frequency of 100 HZ and pulse duration of 0.05 MS and the time of treatment of 15 min. Hot pack, SLR in supine position and A Gal-AL-AS diode laser device with a power output of 3.2 W and a wavelength of 910 NM will be used.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
The Rehabilitation Center of Tabatabaee
Full name of responsible person
Elham Fatemy
Street address
Mashahir Square, in front of Helal Ahmar
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Semnan University of Medical Sciences
Full name of responsible person
Ali Rashidipour
Street address
Kilometer 5, Damghan Road
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham Fatemy
Position
MS.c-Instructor
Other areas of specialty/work
Street address
Kilometer 5, Damghan Road ,Rehabilitation faculty, Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 3334 0867
Fax
Email
fatemyelham@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham Fatemy
Position
MS.c-Instructor
Other areas of specialty/work
Street address
Kilometer 5, Damghan Road ,Rehabilitation faculty, Semnan University of Medical Science
City
Semnan
Postal code
Phone
+98 23 3334 0867
Fax
Email
fatemyelham@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham Fatemy
Position
MS.c-Instructor
Other areas of specialty/work
Street address
Kilometer 5, Damghan Road ,Rehabilitation faculty, Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 3334 0867
Fax
Email
fatemyelham@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)