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Completed

NCT Number: NCT01306435

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of São Paulo General Hospital

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laser

Other

3-week treatment with three Laser sessions per week

Other names: LOW POWER LASER

Placebo Laser

Other

3-week treatment with three Placebo Laser sessions per week

Other names: PLACEBO LOW POWER LASER

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Mar 1, 2011
Registry last updated
Mar 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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