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

Effect of Low-level Laser Therapy (904 nm) and Static Stretching in Patients With Knee Osteoarthritis: Randomised Controlled Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01738737
Enrollment
145
Registered
2012-11-30
Start date
2012-12-31
Completion date
2014-12-31
Last updated
2015-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

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.

Interventions

18 points of application of active laser in the knee (frontal faces, lateral and medial)

OTHERStretching exercises

7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions

18 points of application of placebo laser in the knee (frontal faces, lateral and medial)

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Visual Analogue Scale for PainBaseline and post-intervention, up to 11 weeksThe 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

MeasureTime frameDescription
Change From Baseline in Range of Motion of Flexion of the KneeBaseline and post-intervention, up to 11 weeksHigher values represent better outcomes The assessment will be done in the patient's first evaluation and after each intervention.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis IndexBaseline and post-intervention, up to 11 weeksThe 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 Lequesne Functional QuestionnaireBaseline and post-intervention, up to 11 weeksThe 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 TestBaseline and post-intervention, up to 11 weeksHigher values represent worse outcomes The assessment will be done in the patient's first evaluation and after each intervention.

Countries

Brazil

Participant flow

Participants by arm

ArmCount
Stretching
Seven stretching exercises for lower limbs during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions
25
Placebo Laser + Stretching
application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)
25
Active Laser + Stretching
application of active laser therapy during nine sessions plus stretching exercises during 24 sessions Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial) Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions
25
Active Laser
Application of active laser only during 24 sessions Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)
25
Control
Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
25
Total125

Baseline characteristics

CharacteristicPlacebo Laser + StretchingActive Laser + StretchingActive LaserStretchingControlTotal
Age, Continuous64.8 years
STANDARD_DEVIATION 6.3
62.7 years
STANDARD_DEVIATION 6.8
66.4 years
STANDARD_DEVIATION 5.9
61.4 years
STANDARD_DEVIATION 8.1
62.4 years
STANDARD_DEVIATION 6.3
63.5 years
STANDARD_DEVIATION 6.7
Function10.1 units on Lequesne Functional Question.
STANDARD_DEVIATION 4.7
10.7 units on Lequesne Functional Question.
STANDARD_DEVIATION 4.5
11.4 units on Lequesne Functional Question.
STANDARD_DEVIATION 5.6
10.1 units on Lequesne Functional Question.
STANDARD_DEVIATION 4.4
9.3 units on Lequesne Functional Question.
STANDARD_DEVIATION 4.5
10.3 units on Lequesne Functional Question.
STANDARD_DEVIATION 4.7
Hamstring shortening28.0 degrees25.0 degrees26.0 degrees20.0 degrees24.0 degrees24.6 degrees
Knee range of motion106.0 degrees102.0 degrees93.0 degrees108.0 degrees104.0 degrees102.6 degrees
Mobility - Timed Get up and Go (TUG)15.8 seconds
STANDARD_DEVIATION 4
14.8 seconds
STANDARD_DEVIATION 4
16.0 seconds
STANDARD_DEVIATION 3
15.0 seconds
STANDARD_DEVIATION 3
13.5 seconds
STANDARD_DEVIATION 2.4
15.0 seconds
STANDARD_DEVIATION 3.3
Pain6.5 cm on Visual Analogue Scale (0-10)
STANDARD_DEVIATION 1.7
6.0 cm on Visual Analogue Scale (0-10)
STANDARD_DEVIATION 2.2
5.7 cm on Visual Analogue Scale (0-10)
STANDARD_DEVIATION 2.1
6.5 cm on Visual Analogue Scale (0-10)
STANDARD_DEVIATION 1.4
5.3 cm on Visual Analogue Scale (0-10)
STANDARD_DEVIATION 1.9
6.0 cm on Visual Analogue Scale (0-10)
STANDARD_DEVIATION 1.9
Self-reported symptoms33.4 units on scale WOMAC
STANDARD_DEVIATION 16.6
32.2 units on scale WOMAC
STANDARD_DEVIATION 14.8
39.5 units on scale WOMAC
STANDARD_DEVIATION 20.7
35.2 units on scale WOMAC
STANDARD_DEVIATION 14.8
33.4 units on scale WOMAC
STANDARD_DEVIATION 17.6
34.7 units on scale WOMAC
STANDARD_DEVIATION 16.9
Sex: Female, Male
Female
22 Participants19 Participants18 Participants17 Participants22 Participants98 Participants
Sex: Female, Male
Male
3 Participants6 Participants7 Participants8 Participants3 Participants27 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —
other
Total, other adverse events
0 / 290 / 290 / 290 / 290 / 29
serious
Total, serious adverse events
0 / 290 / 290 / 290 / 290 / 29

Outcome results

Primary

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.

Time frame: Baseline and post-intervention, up to 11 weeks

ArmMeasureValue (MEAN)Dispersion
Active Laser + StretchingChange From Baseline in Visual Analogue Scale for Pain3.2 units on a scaleStandard Deviation 2.1
Placebo Laser + StretchingChange From Baseline in Visual Analogue Scale for Pain3.8 units on a scaleStandard Deviation 2.3
StretchingChange From Baseline in Visual Analogue Scale for Pain3.1 units on a scaleStandard Deviation 2.9
Active LaserChange From Baseline in Visual Analogue Scale for Pain3.3 units on a scaleStandard Deviation 2.2
ControlChange From Baseline in Visual Analogue Scale for Pain0.7 units on a scaleStandard Deviation 3
Secondary

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.

Time frame: Baseline and post-intervention, up to 11 weeks

ArmMeasureValue (MEDIAN)
Active Laser + StretchingChange From Baseline in Lequesne Functional Questionnaire2.5 units on a scale
Placebo Laser + StretchingChange From Baseline in Lequesne Functional Questionnaire1.5 units on a scale
StretchingChange From Baseline in Lequesne Functional Questionnaire4.0 units on a scale
Active LaserChange From Baseline in Lequesne Functional Questionnaire3.5 units on a scale
ControlChange From Baseline in Lequesne Functional Questionnaire0.0 units on a scale
Secondary

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.

Time frame: Baseline and post-intervention, up to 11 weeks

ArmMeasureValue (MEDIAN)
Active Laser + StretchingChange From Baseline in Range of Motion of Flexion of the Knee7.0 degress
Placebo Laser + StretchingChange From Baseline in Range of Motion of Flexion of the Knee10.0 degress
StretchingChange From Baseline in Range of Motion of Flexion of the Knee6.0 degress
Active LaserChange From Baseline in Range of Motion of Flexion of the Knee10.0 degress
ControlChange From Baseline in Range of Motion of Flexion of the Knee1.0 degress
Secondary

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.

Time frame: Baseline and post-intervention, up to 11 weeks

ArmMeasureValue (MEDIAN)
Active Laser + StretchingChange From Baseline in Timed Get Up and Go Test2.5 seconds
Placebo Laser + StretchingChange From Baseline in Timed Get Up and Go Test3.0 seconds
StretchingChange From Baseline in Timed Get Up and Go Test2.6 seconds
Active LaserChange From Baseline in Timed Get Up and Go Test3.1 seconds
ControlChange From Baseline in Timed Get Up and Go Test0.0 seconds
Secondary

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.

Time frame: Baseline and post-intervention, up to 11 weeks

ArmMeasureValue (MEDIAN)
Active Laser + StretchingChange From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index8.0 units on a scale
Placebo Laser + StretchingChange From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index11.0 units on a scale
StretchingChange From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index13.0 units on a scale
Active LaserChange From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index16.0 units on a scale
ControlChange From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index2.0 units on a scale

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026