Low Level Laser Therapy and Interferential Current in Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the effectiveness of the low level laser therapy and interferential current in 168 patients with knee osteoarthritis

Detailed Description
-----------------
Interventional

Official Title
-----------------
Low Level Laser Therapy and Interferential Current in Patients With Knee Osteoarthritis: Randomized Controlled Trial

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: Active Interferential Current
* Device: Active Laser
* Device: Placebo Interferential Current
* Device: Placebo Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of osteoarthritis of the knee characterized by pain of mild or moderate intensity Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria Patients with knee osteoarthritis (s) according to the ACR criteria VAS 3 to 8 5 to 12 Lequesne No complaint of pain in other joints of the lower limbs Without neurological and cognitive disorders No loss of sensation in the lower limbs No surgery on the knee (s) in the last 6 months Pain symptoms for at least 6 months No infiltrations (s) knee (s) in the last 4 weeks No use of analgesics 4 hours before treatment Exclusion Criteria: Individuals younger than 18 and older than 80 years Complaints from other diseases of the lower limbs, knee prosthesis and / or hip joint instabilities and / or surgery in lower limbs, heart disease, uncontrolled hypertension and diabetes, coagulation disorders in anticoagulant therapy, pregnant women, fibromyalgia and individuals who can not perform isokinetic test who have difficulty performing the TUG, and those that are experiencing abnormal sensitivity to algometry

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: G1 (Active IFC and Active Laser)<br>42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. This group (G1) will receive the treatment of Active Interferential Current and Active Laser for 12 sessions. | Device: Active Interferential Current<br>* Involves the application of medium frequency alternating currents<br>* Other names: IFC;Device: Active Laser<br>* Involves the application of low level laser over the knee<br>* Other names: low level laser therapy;|
| Active Comparator: G2 (Active IFC and Placebo Laser)<br>42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. This group (G2) will receive the treatment of Active Interferential Current and Placebo Laser for 12 sessions. | Device: Active Interferential Current<br>* Involves the application of medium frequency alternating currents<br>* Other names: IFC;Device: Placebo Laser<br>* It is a sham laser therapy<br>|
| Active Comparator: G3 (Placebo IFC and Active Laser)<br>42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. This group (G3) will receive Placebo Interferential Current and Active Laser for 12 sessions. | Device: Active Laser<br>* Involves the application of low level laser over the knee<br>* Other names: low level laser therapy;Device: Placebo Interferential Current<br>* It is a sham interferential therapy<br>|
| Placebo Comparator: G4 (Placebo IFC and Placebo Laser)<br>42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. The placebo group (G4) will receive Placebo Interferential Current and Placebo Laser for 12 sessions. | Device: Placebo Interferential Current<br>* It is a sham interferential therapy<br>Device: Placebo Laser<br>* It is a sham laser therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity measured by a numeric pain scale ranging from 0 to 10. |  | 4 weeks | 
| Pressure Pain Threshold measured by a pressure algometer. Pressure will be recorded in kPa. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TUG (Timed Up & Go Test) |  | Measure at baseline, 4 weeks, 3 months, 6 months | 
| Isokinetic Muscle Assessment |  | Measure at baseline, 4 weeks, 3 months, 6 months | 
| LeQuesne Questionnaire |  | Measure at baseline, 4 weeks, 3 months, 6 months | 
| WOMAC (Western Ontario and McMaster Universities Arthritis Index) |  | Measure at baseline, 4 weeks, 3 months, 6 months |