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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01306435
First received: February 23, 2011
Last updated: February 28, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
 Other: Laser
Other: Placebo Laser
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Low Power Laser Associated With Exercises in Osteoartite Knee: Randomized Clinical Trial, Double-blind, Controlled

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Change from baseline in VAS at 3 and 8 weeks [ Time Frame: baseline, 3 and 8 weeks ] [ Designated as safety issue: No ]
    In the VAS the subject marks the intensity of its pain in a centimeter horizontal line


Secondary Outcome Measures:
  • Change from baseline in Lequesne at 3 an 8 weeks [ Time Frame: baseline, 3 and 8 weeks ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in range of motion [ Time Frame: baseline, 3 and 8 weeks ] [ Designated as safety issue: No ]
    ADM flexion and knee extension was measured using a universal goniometer (AESCULAP) with the patient prone

  • Change from baseline in Muscular Strength at 3 and 8 weeks [ Time Frame: baseline, 3 and 8 weeks ] [ Designated as safety issue: No ]
    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

  • Change from baseline in Quality of Life at 3 and 8 weeks [ Time Frame: baseline, 3 and 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: November 2009
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laser Group Other: Laser
3-week treatment with three Laser sessions per week
Other Name: LOW POWER LASER
Placebo Comparator: Placebo Group Other: Placebo Laser
3-week treatment with three Placebo Laser sessions per week
Other Name: PLACEBO LOW POWER LASER

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306435

Locations
Brazil
University of São Paulo General Hospital
São Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Patrícia P Alfredo, MS Faculty of Medicine of the University of São Paulo
Study Director: Amélia P Marques, PhD Faculty of Medicine of the University of São Paulo
  More Information

No publications provided

Responsible Party: Amélia Pasqual Marques, Departamnto Speech Therapy, Physiotherapy and Occupational Therapy, Faculty of Medicine, University of São Paulo, Brazil
ClinicalTrials.gov Identifier: NCT01306435     History of Changes
Other Study ID Numbers: 077508
Study First Received: February 23, 2011
Last Updated: February 28, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
Osteoarthritis
Low Power Laser Therapy
Exercise
Knee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013