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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306435
• Other study ID #: 077508
• Status: Completed
• Phase: Phase 2
• First received: February 23, 2011
• Last updated: February 28, 2011
• Start date: November 2009
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• Laser
3-week treatment with three Laser sessions per week
• Placebo Laser
3-week treatment with three Placebo Laser sessions per week

Locations

Country	Name	City	State
Brazil	University of São Paulo General Hospital	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No