Low Power Laser and Exercise in Osteoarthritis of the Knee: a Randomized Clinical Trial

Study Overview
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Brief Summary
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Indroduction: Knee osteoarthritis (OA) is a painful condition causing disability, weakness and poor quality of live. The results are very consistent about the benefits of laser and exercises to improve pain and function in subjects with knee osteoarthritis Objectives: To investigate the effects of Low Power Laser (LBP) associated with exercise in pain, function, range of motion, muscle strength and quality of life of patients with knee osteoarthritis. Methods: Forty patients of both sexes aged between 50 and 75 years with knee osteoarthritis (grade 2-4) were randomized into two groups: Laser-LBP-active dose of 3J more exercises and Group Placebo-LBP- placebo and exercise. Were evaluated for pain, function, range of motion, muscle strength and quality of life on three occasions: before starting treatment (evaluation 1), 3 weeks after laser application (evaluation 2) and 8 weeks after completion of exercise (evaluation 3). There were 33 physical therapy sessions three times a week, on March 1 and the laser was applied in the other, only the exercises.

Detailed Description
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Pain: Pain intensity was measured with the Visual Analogue Scale (VAS) which is a straight 10 cm long devoid of numbers, in which there is only an indication of the extreme left of no pain and extreme right to unbearable pain. The higher the score, the greater the pain. Feature: Survey conducted by Lequesne, which is an index composed of 11 questions about pain, discomfort and function. The scores range from 0 to 24 (without affecting the extremely severe, respectively), the higher the score, the greater the impairment. Range of motion (ROM): ADM flexion and knee extension was measured using a universal goniometer (AESCULAP) with the patient prone second methodology Marques. Muscular Strength: To assess the maximal isometric strength of the quadriceps muscle was used Dynamometer model Lafayette ® Portable (USA), while seated at 60 ° of knee flexion and this gradation was controlled with a goniometer. Patients remained seated on the stretcher and held steady with thigh extension strength, the dynamometer being maintained in the distal leg. Three measurements were taken, and the mean value. Quality of Life: The Questionnaire was used Western Ontario and McMaster Universities Osteoarthritis (WOMAC)a self-assessment that evaluates pain, stiffness and physical activity. The higher the score, the greater the impact of OA on quality of life.

Official Title
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Effects of Low Power Laser Associated With Exercises in Osteoartite Knee: Randomized Clinical Trial, Double-blind, Controlled

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: Laser
* Other: Placebo Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnoses of osteoarthritis Knee pain Functional reduction in the last three months Grade 2-4 OA Fulfilled at least one of the classification criteria of the American College of Rheumatology Exclusion Criteria: Cancer Diabetes mellitus Symptomatic hip OA Antidepressants Anti-inflammatory steroidal and nonsteroidal or tranquilizers in the last six months and throughout the treatment

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Group<br> | Other: Laser<br>* 3-week treatment with three Laser sessions per week<br>* Other names: LOW POWER LASER;|
| Placebo Comparator: Placebo Group<br> | Other: Placebo Laser<br>* 3-week treatment with three Placebo Laser sessions per week<br>* Other names: PLACEBO LOW POWER LASER;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in VAS at 3 and 8 weeks | In the VAS the subject marks the intensity of its pain in a centimeter horizontal line | baseline, 3 and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Lequesne at 3 an 8 weeks | Lequesne index is a composite of 11 questions about pain, discomfort and function. The scores range from 0 to 24 (without affecting the extremely severe, respectively), the higher the score, the greater the impairment. | baseline, 3 and 8 weeks | 
| Change from baseline in range of motion | ADM flexion and knee extension was measured using a universal goniometer (AESCULAP) with the patient prone | baseline, 3 and 8 weeks | 
| Change from baseline in Muscular Strength at 3 and 8 weeks | To assess the maximal isometric strength of the quadriceps muscle was used Dynamometer model Lafayette ® Portable (USA), while seated at 60 ° of knee flexion and this gradation was controlled with a goniometer. Patients remained seated on the stretcher and held steady with thigh extension strength, the dynamometer being maintained in the distal leg. Three measurements were taken, and the mean value | baseline, 3 and 8 weeks | 
| Change from baseline in Quality of Life at 3 and 8 weeks | The Questionnaire was used Western Ontario and McMaster Universities Osteoarthritis (WOMAC) a self-assessment that evaluates pain, stiffness and physical activity. The higher the score, the greater the impact of OA on quality of life. | baseline, 3 and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Low Power Laser Therapy, Exercise, Knee