Effect of Static Stretching and Low Intensity Laser Therapy in Patients With Knee Osteoarthritis: Randomized Clinical Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Sao Paulo General Hospital
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01738737
First received: August 28, 2012
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

Introduction: Osteoarthritis (OA) is a prevalent disease associated with significant morbidity, one of the most common causes of functional limitations and dependence. This study aims to investigate the effects of low intensity laser therapy (904nm) and stretching exercises in pain, range of motion, flexibility, functionality and quality of life of patients with knee OA according to the criteria of the American College of rheumatology. Methods: The sample consists of 125 patients aged between 50 and 75 years, from the Rehabilitation Center in the city of Taboão da Serra - São Paulo/Brasil, who have knee pain, functional reduction in the last three months and grade between 2 and 4 classification of OA by Kellgren and Lawrence (1957). Patients will be divided into five groups: Group A - Low Intensity Laser Therapy (LILT) with an active dose of 3 Joules more stretching exercises, Group B - LILT placebo plus stretching exercises, Group C - only stretching exercises, Group D - only LILT and Group E - control. For groups A and B, in the first three weeks, the treatment will be done with the LILT (active or placebo) totaling nine sessions and in the next eight weeks will be performed stretching exercises totaling 24 sessions. C and D groups will realize eight weeks of stretching exercises and LILT, respectively. The patients will be assessed before and after each intervention. The clinical evaluation includes pain intensity by visual analogue scale (VAS) functionality by the Lequesne's Functional Questionnaire and Get Up and Go Test, the range of movement of flexion and knee extension and shortening of the hamstrings with the goniometer; flexibility through the finger-to-floor distance test and the quality of life by the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The data will be considered statistically significant at ± <0.05.


Condition Intervention
Osteoarthritis, Knee
Device: low intensity laser therapy (904nm)
Other: Stretching exercises
Device: placebo laser therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Static Stretching and Low Level Laser Therapy in Patients With Knee Osteoarthritis: Randomized Clinical Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in Visual Analogue Scale for pain [ Time Frame: before and after each intervention ] [ Designated as safety issue: No ]
    The assessment will be done in the patient's first evaluation and after each intervention.


Secondary Outcome Measures:
  • Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: Before and after each intervention ] [ Designated as safety issue: No ]
    The assessment will be done in the patient's first evaluation and after each intervention.

  • Change from baseline in range of motion of flexion and extension of the knee [ Time Frame: Before and after each intervention ] [ Designated as safety issue: No ]
    The assessment will be done in the patient's first evaluation and after each intervention.

  • Change from baseline in Lequesne Functional Questionnaire [ Time Frame: Before and after each intervention ] [ Designated as safety issue: No ]
    The assessment will be done in the patient's first evaluation and after each intervention.

  • Change from baseline in Get Up and Go Test [ Time Frame: Before and after each intervention ] [ Designated as safety issue: No ]
    The assessment will be done in the patient's first evaluation and after each intervention.


Estimated Enrollment: 125
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stretching
Seven stretching exercises for lower limbs during 24 sessions
Other: Stretching exercises
7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions
Experimental: Placebo laser + Stretching
application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions
Other: Stretching exercises
7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions
Device: placebo laser therapy
18 points of application of placebo laser in the knee (frontal faces, lateral and medial)
Other Name: LaserPulse class II IBRAMED
Experimental: Active laser + Stretching
application of active laser therapy during nine sessions plus stretching exercises during 24 sessions
Device: low intensity laser therapy (904nm)
18 points of application of laser in the knee (frontal faces, lateral and medial)
Other Name: LaserPulse class II IBRAMED
Other: Stretching exercises
7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions
Experimental: Active Laser
Application of active laser only during 24 sessions
Device: low intensity laser therapy (904nm)
18 points of application of laser in the knee (frontal faces, lateral and medial)
Other Name: LaserPulse class II IBRAMED
No Intervention: Control
Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.

Detailed Description:

Physical performance as a determinant of disability in osteoarthritis (OA) has been investigated extensively, but research has focused primarily on the effect that the decrease in muscle strength has on the functionality in patients with OA. However, the reduced range of motion in affected joints is also an important risk factor for the occurrence of locomotor disability and other developing disability in patients with OA.

Studies using stretching exercises are scarce in the Reid & Mc Nair (2010) specifically examined the range of motion can be improved in subjects with knee osteoarthritis, although this study did only stretching the hamstrings. The results indicate that there is immediate benefits of stretching in subjects with osteoarthritis of the knee joint, providing evidence for the long term development of stretching programs for this population.

In the literature are observed inconsistent results regarding the benefits of laser treatment in improving pain and function in individuals with knee OA. Also there are few studies that specify which dosage and frequency of laser must be used.

In view of the increasing need to support the role of physiotherapy in evidence-based practice, this study is justified by the need to test the effectiveness of stretching exercises and elucidate the effectiveness of low intensity laser therapy in patients with knee OA.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of knee osteoarthritis
  • functional reduction in the last three months
  • osteoarthritis´s grade 2-4 (Kellgren and Lawrence, 1957)

Exclusion Criteria:

  • cancer
  • insulin dependent diabetes
  • symptomatic hip osteoarthritis
  • impossibility of performing the evaluation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738737

Locations
Brazil
Specialized rehabilitation service Recruiting
Taboao da Serra, Sao Paulo, Brazil, 55
Contact: Sarah Meneses    41388550    sarahmeneses@gmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Sarah Rubia F Meneses University of Sao Paulo
  More Information

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01738737     History of Changes
Other Study ID Numbers: CAPPESQ 455/11
Study First Received: August 28, 2012
Last Updated: November 1, 2013
Health Authority: Brazil: Ethics Committee

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

ClinicalTrials.gov processed this record on July 22, 2014