The effects of high power laser therapy vs low level laser therapy on the range of motion , functional ability and quadriceps architecture in patients with knee osteoarthritis : A double blinded randomized clinical trial
The effects of high power laser therapy vs low level laser therapy on the range of motion , functional ability and quadriceps architecture in patient with knee osteoarthritis
Design
A randomized, controlled, blinded, clinical trial with a parallel group design of 75 patients
Settings and conduct
The effects of laser therapy in patients with osteoarthritis. All procedures will be performed in poursina hispital, Guilan university of medical sciences. The patients will be in 3 groups double blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 40-70 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- Ultrasound: Intensity 1 w/cm2, continuous on both sides of the knee about 4 minutes 4- Exercise for strengthening muscle should include 10 exercises up to 4 weeks.
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
Fiber angle and length; volume and thickness of vastus medialis oblique and vastus lateralis muscles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516034003N5
Registration date:2019-04-21, 1398/02/01
Registration timing:prospective
Last update:2019-04-21, 1398/02/01
Update count:0
Registration date
2019-04-21, 1398/02/01
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
2019-05-10, 1398/02/20
Expected recruitment end date
2019-11-11, 1398/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of high power laser therapy vs low level laser therapy on the range of motion , functional ability and quadriceps architecture in patients with knee osteoarthritis : A double blinded 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
Visual analogue scale (VAS) score of 3 or more
Body mass index<30
Exclusion criteria:
The patients with rheumatoid arthritis; malignancy; knee surgery; fracture; complete tear anterior cruciate ligament or menisci; athletics; neuropathy, genu valgum or varum more than 20 degree; hyalgan or corticosteroids injection in last 6 months.
Physiotherapy in last month
grade 3 and 4 Kellgren-Lawrence in radiologic examination
Bilateral knee pain or local infection
Acute bursitis or tendinitis of the knee
Referral pain from lumbar or hip to knee.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
75
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, dominant side and affected knee. 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)
Double blinded
Blinding description
The examiner and statistical analyzer won't know anything about the kind of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
5th floor, Central office of Guilan University of Medical Sciences, Namjoo St., Rasht, Iran
City
Rasht
Province
Guilan
Postal code
۴۱۹۳۷۱۳۱۹۴
Approval date
2019-01-10, 1397/10/20
Ethics committee reference number
IR.GUMS.REC.1397.366
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 intervention, After ten sessions treatments, one month follow-up
Method of measurement
Visual Analogue Scale
2
Description
Fiber angle; volume and thickness of vastus medialis oblique
Timepoint
Before intervention, After ten sessions treatments, one month follow-up
Method of measurement
Using ultrasonography
3
Description
Fiber angle and length; volume and thickness of vastus lateralis
Timepoint
Before intervention, After ten sessions treatments, one month follow-up
Method of measurement
Using ultrasonography
Secondary outcomes
empty
Intervention groups
1
Description
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- Ultrasound: Intensity 1 w/cm2, continuous on both sides of the knee about 4 minutes 4- Exercise for strengthening muscle should include 10 exercises up to 4 weeks.
Category
Rehabilitation
2
Description
2- Low level laser therapy: All interventions in control group with low level laser therapy: Laser therapy (laser med, Carci, brazil) with 808 nm wavelength, 12 joules, 50 mW on 12 points of the knee. Each point treatment time will be 91 seconds.
Category
Rehabilitation
3
Description
3- High power laser therapy: All interventions in control group with high power laser therapy: Laser therapy (High power laser, pagani, Italy) with 808 nm wavelength, 12 joules, 1.6W on all areas of the . Treatment time will be 150 seconds.