To determine and compare the mean pain, range of motion and edema in patients with patellofemoral pain syndrome before treatment , after 10 sessions treatment in low level laser therapy and control groups.
Design
Randomized controlled clinical trial with parallel groups and double blinded
Settings and conduct
The rationale for this research is to determine the effects of low level laser therapy on pain, range of motion and edema in patients with patellofemoral pain syndrome. This study will be conducted at poursina hospital and neither patients no examiner know the grouping and treatments procedures.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20 to 45years. Patellofemoral pain syndrome diagnosis: According to orthopedic physician assessment; Exclusion criteria: Patients with patellofemoral pain syndrome without effusion . Patients with arthrosis grade III and IV according to X-Ray. Patients with tibia, patella, femur and fibula fractures. Patients with history of femur and other bones surgery, or meniscus and cruciate ligaments and tendon surgery. Patients with complete soft tissues tear such as meniscus and cruciate ligaments. Patients with referral pain form lumbar or hip and local infections. Addict or pregnant individuals. Patients that took part in physiotherapy program about during 2 weeks ago. Patients with history of rheumatoid diseases such as rheumatoid arthritis.
Intervention groups
Control group receive routine physical therapy treatments and intervention group receive routine physical therapy as well as low level laser therapy
Main outcome variables
Knee pain; Knee range of motion; Knee effusion;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516034003N6
Registration date:2019-05-28, 1398/03/07
Registration timing:prospective
Last update:2019-05-28, 1398/03/07
Update count:0
Registration date
2019-05-28, 1398/03/07
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
2019-06-05, 1398/03/15
Expected recruitment end date
2019-11-06, 1398/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effects of low level laser therapy on pain, range of motion and edema in people suffering from patellofemoral pain syndrome
Public title
The effects of laser therapy on pain and edema
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patellofemoral pain syndrome diagnosis: According to orthopedic physician assessment
-Age between 20-45 years
Exclusion criteria:
Patients with patellofemoral pain syndrome without effusion.
Patients with arthrosis grade III and IV; fractures; history of surgery; patients with complete soft tissues tear.
Age
From 20 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
The grouping method will be Permuted block randomization . So, blocks of 10 people including 5 participants in the intervention group and 5 participants in the control group are allocated.
Blinding (investigator's opinion)
Double blinded
Blinding description
The examiner won't know anything about the kind of treatment. The Patients and therapists will also not know anything about grouping and kind of interventions.
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
2019-05-16, 1398/02/26
Ethics committee reference number
IR.GUMS.REC.1398.066
Health conditions studied
1
Description of health condition studied
Patellofemoral pain syndrome
ICD-10 code
M22.2X
ICD-10 code description
Patellofemoral disorders
Primary outcomes
1
Description
Pain
Timepoint
Before and after intervention
Method of measurement
Visual Analogue Scale
2
Description
Edema score
Timepoint
Before and after intervention
Method of measurement
Tape
3
Description
Range of motion
Timepoint
Before and after intervention
Method of measurement
Goniometer
Secondary outcomes
empty
Intervention groups
1
Description
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 individual. The patient will feel mild heat. 2- Treatment with transcutaneous electrical nerve stimulation(TENS) type brief for 20 minutes. In this method, four electrodes on the sides of the knee will be used. The frequency used varies from 3 to 120 Hz, and the patient will feel the electrical current, along with the muscle vibrations. 3- Exercise for strengthening muscle should include five exercises from the third to the tenth sessions twice daily.
Category
Rehabilitation
2
Description
Intervention 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 individual. The patient will feel mild heat. 2- Treatment with TENS type brief for 20 minutes. In this method, four electrodes on the sides of the knee will be used. The frequency used varies from 3 to 120 Hz, and the patient will feel the electrical current, along with the muscle vibrations. 3- Exercise for strengthening muscle should include five exercises from the third to the tenth sessions twice daily. 4. Laser therapy: In this study, a laser with a wavelength of 905 nm, an energy density of 8 J / cm 2, a power of 50 mW in 10 points of the knee including 4 points on the anterior knee , 2 points on the medial knee, 2 points on the lateral knee, 2 points on the posterior knee. The radiation time will be 91s for each point.