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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active Laser
Stretching exercises
placebo laser therapy
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Specialized rehabilitation service

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Stretching

Placebo laser + Stretching

Active laser + Stretching

Active Laser

Control

Arm Description

Seven stretching exercises for lower limbs during 24 sessions

application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions

application of active laser therapy during nine sessions plus stretching exercises during 24 sessions

Application of active laser only during 24 sessions

Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.

Outcomes

Primary Outcome Measures

Change From Baseline in Visual Analogue Scale for Pain
The scale varies from 0 to 10. Higher values represent worse outcomes. 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
The scale varies from 0 to 96. Higher values represent worse outcomes. The assessment will be done in the patient's first evaluation and after each intervention.
Change From Baseline in Range of Motion of Flexion of the Knee
Higher values represent better outcomes The assessment will be done in the patient's first evaluation and after each intervention.
Change From Baseline in Lequesne Functional Questionnaire
The scale varies from 0 to 24. Higher values represent worse outcomes 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
Higher values represent worse outcomes The assessment will be done in the patient's first evaluation and after each intervention.

Full Information

First Posted
August 28, 2012
Last Updated
November 6, 2015
Sponsor
University of Sao Paulo General Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT01738737
Brief Title
Low-level Laser Therapy and Static Stretching in Knee Osteoarthritis.
Official Title
Effect of Low-level Laser Therapy (904 nm) and Static Stretching in Patients With Knee Osteoarthritis: Randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stretching
Arm Type
Experimental
Arm Description
Seven stretching exercises for lower limbs during 24 sessions
Arm Title
Placebo laser + Stretching
Arm Type
Experimental
Arm Description
application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions
Arm Title
Active laser + Stretching
Arm Type
Experimental
Arm Description
application of active laser therapy during nine sessions plus stretching exercises during 24 sessions
Arm Title
Active Laser
Arm Type
Experimental
Arm Description
Application of active laser only during 24 sessions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
Intervention Type
Device
Intervention Name(s)
Active Laser
Other Intervention Name(s)
LaserPulse (904nm) class II IBRAMED
Intervention Description
18 points of application of active laser in the knee (frontal faces, lateral and medial)
Intervention Type
Other
Intervention Name(s)
Stretching exercises
Intervention Description
7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions
Intervention Type
Device
Intervention Name(s)
placebo laser therapy
Other Intervention Name(s)
LaserPulse class II IBRAMED
Intervention Description
18 points of application of placebo laser in the knee (frontal faces, lateral and medial)
Primary Outcome Measure Information:
Title
Change From Baseline in Visual Analogue Scale for Pain
Description
The scale varies from 0 to 10. Higher values represent worse outcomes. The assessment will be done in the patient's first evaluation and after each intervention.
Time Frame
Baseline and post-intervention, up to 11 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index
Description
The scale varies from 0 to 96. Higher values represent worse outcomes. The assessment will be done in the patient's first evaluation and after each intervention.
Time Frame
Baseline and post-intervention, up to 11 weeks
Title
Change From Baseline in Range of Motion of Flexion of the Knee
Description
Higher values represent better outcomes The assessment will be done in the patient's first evaluation and after each intervention.
Time Frame
Baseline and post-intervention, up to 11 weeks
Title
Change From Baseline in Lequesne Functional Questionnaire
Description
The scale varies from 0 to 24. Higher values represent worse outcomes The assessment will be done in the patient's first evaluation and after each intervention.
Time Frame
Baseline and post-intervention, up to 11 weeks
Title
Change From Baseline in Timed Get Up and Go Test
Description
Higher values represent worse outcomes The assessment will be done in the patient's first evaluation and after each intervention.
Time Frame
Baseline and post-intervention, up to 11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Rubia F Meneses
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Specialized rehabilitation service
City
Taboao da Serra
State/Province
Sao Paulo
ZIP/Postal Code
06775-005
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
26369333
Citation
Ferreira de Meneses SR, Hunter DJ, Young Docko E, Pasqual Marques A. Effect of low-level laser therapy (904 nm) and static stretching in patients with knee osteoarthritis: a protocol of randomised controlled trial. BMC Musculoskelet Disord. 2015 Sep 14;16:252. doi: 10.1186/s12891-015-0709-9.
Results Reference
derived

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

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