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

NCT ID: NCT01306435

Last Updated: 2011-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-02-28

Brief Summary

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

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Laser Group

Group Type: EXPERIMENTAL

Laser

Intervention Type: OTHER

3-week treatment with three Laser sessions per week

Placebo Group

Group Type: PLACEBO_COMPARATOR

Placebo Laser

Intervention Type: OTHER

3-week treatment with three Placebo Laser sessions per week

Interventions

Laser

3-week treatment with three Laser sessions per week

Intervention Type: OTHER

Placebo Laser

3-week treatment with three Placebo Laser sessions per week

Intervention Type: OTHER

Other Intervention Names

LOW POWER LASER; PLACEBO LOW POWER LASER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Departamnto Speech Therapy, Physiotherapy and Occupational Therapy, Faculty of Medicine, University of São Paulo, Brazil

Principal Investigators

Patrícia P Alfredo, MS

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine of the University of São Paulo

Amélia P Marques, PhD

Role: STUDY_DIRECTOR

Faculty of Medicine of the University of São Paulo

Locations

University of São Paulo General Hospital

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

077508

Identifier Type: -

Identifier Source: org_study_id