Comparing the short-term Effects of Continues, Pulsed and Super pulsed High power Laser irradiation on Pain and Function in Patient with Knee Osteoarthritis

The main purpose of this study is comparing the short-term effects of continues, pulsed and super-pulsed high power laser irradiation on pain and function in the patients with knee osteoarthritis.

A triple blinded randomized trial with parallel groups

52 patients (male and female) called to Shiraz Shahid Beheshti hospital Physiotherapy department will be enrolled in the study. These patients should have including criteria of this study with mild to moderate knee osteoarthritis. Also, they should sign a written informed consent for study participation. After that, they will be simply randomized to three groups (continuous, pulsed and super-pulsed high power laser with three routine exercises) through random number table. Demographic specifications of patients such as age, sex, and treatment group will be recorded in data collecting form. For blinding of study, none of the researcher or the evaluator won't know about grouping. Also, the Patients won't know which group they will be assigned or which treatment they will be offered. Each of patients will be evaluated for pain (through Visual Analog Scale "VAS" and Macgill Questionaire "MPQ"), edema in 3 locations (around the knee joint, 10 cm above and 10 cm belong that) using a measuring tape, Range of active knee extension, active and passive knee flexion and active and passive popliteal angle measuring by a goniometer before the first and immediately after the first and the fifth sessions. Also, the knee function of all patients will be evaluated before the first and immediately after the fifth session. All of the data will be recorded and, the results of them will be assessed.

Inclusion Criteria: 1) Age ≥ 50 2) The osteoarthritic knee grade 2-3 based on radiographic diagnosis in the Kellegren and Lawrence grading of osteoarthritis by orthopedist physician. 3) The minimum score of 25 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score. 4) Knee pain ≥ 4 on the visual analog scale (VAS) Exclusion Criteria: 1) History of physiotherapy or intra-articular injections during last 6 months. 2) Any history of knee surgery 3) History of fracture in knee 4) History of tearing of tendons, ligaments, and menisci in knee joint 5) Central or peripheral neuropathy 6) Rheumatoid Arthritis 7) Malignancy in knee joint 8) Psychologic problems 9) Metabolic disease such as Diabetes, Thyroid, and Kidney problems 10) Infective disease 11) Ankylosis 12) Sever Synovitis 13) Sever valgus or Varus deformity 14) Incomplete treatment for any reasons 15) Osteoarthritic knee of grade 1,4 based on radiographic diagnosis in the Kellegren and Lawrence grading of osteoarthritis

1) Continuous-high power laser group: Five sessions, on consecutive days, with continuous high power laser accompanied by 3 routine exercise for knee osteoarthritis. In this group, according to the knee-arthrosis protocol of the device (from continuous source), the laser will be irradiated on 8 points of the knee joint with the total energy dose of 251.2 J during 10 min. 2) Pulsed-high power laser group: Five sessions, on consecutive days, with pulsed-high power laser accompanied by 3 routine exercise for knee osteoarthritis. In this group, according to the Analgesic protocol of the device (from pulsed source), the laser will be irradiated on 8 points of the knee joint with the total energy dose of 199 J during 10 min. 3) Super-pulsed-high power laser group: Five sessions, on consecutive days, with super-pulsed-high power laser accompanied by 3 routine exercise for knee osteoarthritis. In this group, according to the Knee-arthrosis protocol of the device (from super-pulsed source), the laser will be irradiated on 8 points of the knee joint with the total energy dose of 565 J during 10 min.

1) Pain Score 2) Knee Function Score 3) Edema of the knee joint, 10 cm above and 10 cm belong that. 4) Active Knee Extension ROM 5) Active Knee Flexion ROM 6) Passive Knee Flexion ROM 7) Active Popliteal Angle 8) Passive Popliteal Angle

The patients are simply randomized to three experimental groups (Pulsed and Super pulsed High power Laser ) through random number table; received a special code and are treated with own group treatment.

treatments are done by the researcher and; evaluations are done by another evaluator; none of them doesn't understand about patients grouping. moreover, analysis of data is done by a statistician who doesn't know about grouping. Also, the patients don't know about their group and other groups.

Only the results of the analyzed personal data such as primary outcomes will be shared after making them unknown.

Start of access from 2020

The data are accessible only for researchers of the universities and Scientific institues

The data will be shared only for helping knowledge of researchers. Any statistical and analytic use of data are forbidden.

Nadia Rahimpour Postal Address: No. 267, 8/1 Ave., 1 Ave., Jomhouri Blvd., Shiraz, Iran. E mail: rahimpourpt@gmail.com Tel: 0098 71 32286628 Mobile: 0098 9177164101

After receiving request for data cashing requester identity and reason of request will be considered. Then the data will be sent maximally during 2 months for requester.