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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01306435
First Posted: March 1, 2011
Last Update Posted: March 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo General Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (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:


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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 23, 2011
First Posted: March 1, 2011
Last Update Posted: March 1, 2011
Last Verified: February 2011

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

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