The Effect of High Power Laser Therapy on Pain and Physical Performance of Patient with Knee Osteoarthritis in comparison with conventional physical therapy.
The purpose of this study was to determine the effectiveness of High Power Laser Therapy (HPLT) in pain, range of motion, functional test, WOMAC questionnaire scores in patients with knee osteoarthritis compared with conventional physiotherapy. Sixty-two male and female patients aged between 50 to 75 years with primary knee osteoarthritis grade 2, 3 according Kellgren and Lawrence scale, assigned randomly into two groups; HPLT and conventional physiotherapy(CT) groups.
After signing written consent, the subject will receive HPLT and a physical therapy program and a standard exercise therapy protocol which was same for both groups in multi center of sports medicine clinics. Patients at the beginning and end of the intervention and also three months (12 weeks) after the intervention will be assessed for primary outcomes included pain intensity, knee range of motion and secondary outcomes included functional tests and joint stiffness and activity of patient through WOMAC questionnaire.
General information
Acronym
High Power Laser Therapy & Knee Osteoarthritis
IRCT registration information
IRCT registration number:IRCT201701025486N5
Registration date:2017-06-19, 1396/03/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-19, 1396/03/29
Registrant information
Name
Azar Moezy
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2446
Email address
moeziazr@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of High Power Laser Therapy on Pain and Physical Performance of Patient with Knee Osteoarthritis in comparison with conventional physical therapy.
Public title
The Effect of High Power Laser Therapy on Knee Osteoarthritis .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: primary OA of the knee joint grade 2, 3 according Kellgren and Lawrence scale; age between 50-75; suffering from knee pain for at least six months and with intensity 3 on the VAS scale in activities such as going up and down stairs, sitting and squat; no history of knee intra-articular injection in the past six months; no history of acute traumatic injuries; no history of previous surgery or injury in the knee joints and lower extremities; having a referral from a doctor; BMI equal to or less than 30; patient's consent to participate in the research; lack of neuromuscular disease; normal mental state; absence of bone implants; no history of new fractures; lack of cancerous tumors; no history of chronic disease such as epilepsy, migraine, acute hernia and generally any disease or condition that is known to affect the investigation; participate in sports programs and physical therapy in the recent three months.
Exclusion criteria: unwillingness to participate in the study; uncompleted evaluation programs; uncompleted treatment programs; any damage in the knee joint during the study; using any other treatment except for the treatment prescribed in the research project.
Age
From 50 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization:
Random allocation of the subjects was done by using a random number table and block random sampling; A: HPLT & B: CT (a block size of 4).
Block 1: AABB
Block 2: ABAB
Block 3: BBAA
Block 4: BABA
Block 5: ABBA
Block 6: BAAB
In this study the patient, the therapist, as well as the assessor will be blinded to the study groups.The exact type of physical modalities will not be inserted in the consent form so the patient will be blind to treatment.
In this study, the patients in HPLT group will be treated on even days and the other group patients will receive their treatment on odd days, to be unaware of treatment programs.
The exact type of physical modalities will not be written in the consent form so the patients of each group will be blind to treatment. It should be noted that the exercise therapy protocol will be individually trained to the patient in the first day and an exercise therapy pamphlet with necessary pictures and explanations will be given to the patient to do exercises at home.
In addition to the therapists who are responsible for doing therapeutic interventions are different in even and odd days, thus they will be blind to the intervention of the groups. Also, the assessor, a sports medicine assistant, who will evaluate the outcomes pre and post intervention in sports medicine clinic , will be blind to the patients in groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Sports Medicine Department, Hazrat Rasool Akram Hospital- Sattarkhan Ave, Niayesh St.
City
Tehran
Postal code
14455613131
Approval date
2016-10-18, 1395/07/27
Ethics committee reference number
IR.IUMS.REC 1395.9311225004
Health conditions studied
1
Description of health condition studied
Primary knee osteoarthritis
ICD-10 code
M17.0 ,M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
Pain
Timepoint
pre / post intervention and three months after the intervention
Method of measurement
VAS pain scale
2
Description
Active knee range of motion
Timepoint
Pre / post intervention and three months after the intervention
Method of measurement
Goniometer
Secondary outcomes
1
Description
Joint stiffness and functional state
Timepoint
Pre/Post and three months after Intervention
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index
2
Description
Functional Activity
Timepoint
Pre/Post and three months after Intervention
Method of measurement
Timed Up & Go Test / Six-Minute Walk Test
Intervention groups
1
Description
Intervention 1 (for HPLT group): The patients will be treated by high-power laser through PYSIOMED system (Belgium ) while the patient lying supine with the knee at 30 ° flexion three times a week for 10 sessions. The applicator (size:6 cm) will be placed vertically in contact with the joint and the knee in longitudinal and perpendicular direction will be scanned and irradiated with HPLT for 8 minutes with a power of 5 watts, duty cycle of 70%, frequency of 30 Hz and energy density 60 joules per square centimeter.
Category
Rehabilitation
2
Description
Intervention 2( for the control group): The patients will be treated by Combined BTL-4825 S Topline including High-frequency TENS( Duration: 50 microseconds, pulse rate :100 Hz with a maximum intensity tolerable for the patient , two electrodes on either side of the knee ,the treatment time : 20 minutes ) and Ultrasound (frequency: 1 MHz, mode: Continuous, probe size: 5 cm, treatment time: 8 minutes in the medial and lateral parts of knee in the supine position and with acoustic gel.) three times a week for 10 sessions.
Category
Rehabilitation
3
Description
Intervention 3- Common protocol for both groups:
Exercise therapy: Also, both groups receive the same, standardized exercise therapy for knee osteoarthritis as follows: 1. Warm-up exercises: slow walking for 5 minutes, hamstring stretch and calf stretch. 2. Major exercises for knee osteoarthritis: SLR (Straight Leg Raise), quadriceps setting, pillow squeeze, heel raise, one leg balance, step ups, quadriceps strengthening exercise.
Medication: In order to unify the participants’ medications, all patients will be asked to stop taking their medications one week before the beginning the study and Acetaminophen will prescribe for them at a dose of two grams per day.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sports Medicine clinics in Iran University of Medical Sciences
Full name of responsible person
Dr Ahmad Nazari
Street address
Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Zhilla Chashmi
Street address
Iran University of Medical Sciences, Research Deputy, Central Headquarters (fifth floor),Hemat Highway between Sheikh Fadlallah and Chamran Expressway.
City
Tehran
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, Iran University of Medical Sciences