Low-level Laser Therapy and Static Stretching in Knee Osteoarthritis.

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Sao Paulo General Hospital
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01738737
First received: August 28, 2012
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

Osteoarthritis (OA) is a highly prevalent and disabling disease. It is estimated that by 2030 the prevalence of symptomatic OA could reach 30% of the population above 60 years. It is associated with significant morbidity being one of the most common causes of joint pain, functional disability and compromised quality of life. This randomised controlled trial will investigate the effect of low-level laser therapy (LLLT) and static stretching exercises, as monotherapy and in combination, on pain, quality of life, function, mobility, knee range of motion (KROM) and hamstring length in participants with knee OA.

This study will involve 145 people aged 50-75 years with symptomatic radiographic knee OA and will consist of two types of treatments: Low-level laser therapy (LLLT) and stretching exercises. The patients will be randomly allocated to five study groups LLLT active+Stretch, LLLT placebo+Stretch, Stretch, LLLT and Control (with n=29 each). Treatment frequency will be three sessions/week for all active groups. LLLT will involve the use of a Galium-Arsenide laser (904nm, 40 milliwatts, 3 Joules/point, 27 Joules/knee) over 24 sessions for the monotherapy group and 9 sessions for the LLLT+Stretch groups. Stretching will consist of seven exercises completed over 24 sessions. The control group will receive a booklet.

The primary outcome is pain measured by Visual Analogue Scale. Secondary outcomes included quality of life assessed by Western Ontario and McMaster Universities Arthritis Index (WOMAC), function by Lequesne Algofunctional Index, mobility by Timed Up and Go Test (TUG), KROM by goniometry of knee flexion and hamstring shortening by popliteal angle. The statistical method will follow the principles of per-protocol analysis.


Condition Intervention
Osteoarthritis, Knee
Device: Active Laser
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 Low-level Laser Therapy (904 nm) and Static Stretching in Patients With Knee Osteoarthritis: Randomised Controlled 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 Timed 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: 145
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 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: Active Laser
18 points of application of active laser in the knee (frontal faces, lateral and medial)
Other Name: LaserPulse (904nm) 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: Active Laser
18 points of application of active laser in the knee (frontal faces, lateral and medial)
Other Name: LaserPulse (904nm) 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:

  • radiographic evidence of knee osteoarthritis between 2-4 in Kellgren & Lawrence classification
  • pain intensity ≥3 on a 10cm Visual Analogue Scale (VAS)
  • knee symptoms for at least 3 months

Exclusion Criteria:

  • symptomatic hip osteoarthritis
  • any disease where laser treatment is contraindicated (cancer and uncontrolled diabetes mellitus)
  • continuous use of anti-inflammatory drugs
  • other concurrent injury/conditions that will affect their ability to participate in the rehabilitation program and/or assessment procedures.
  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, 06775-005
Contact: Sarah Meneses    +55 (11) 4138-8550    sarahmeneses@gmail.com   
Principal Investigator: Sarah Meneses, PhD student         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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: September 16, 2014
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 September 18, 2014