Osteoarthritis, Knee
Conditions
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)
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Visual Analogue Scale for Pain | Baseline and post-intervention, up to 11 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Range of Motion of Flexion of the Knee | Baseline and post-intervention, up to 11 weeks | Higher 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 Index | Baseline and post-intervention, up to 11 weeks | 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 Lequesne Functional Questionnaire | Baseline and post-intervention, up to 11 weeks | 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 | Baseline and post-intervention, up to 11 weeks | Higher 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
| Arm | Count |
|---|---|
| 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 |
| Total | 125 |
Baseline characteristics
| Characteristic | Placebo Laser + Stretching | Active Laser + Stretching | Active Laser | Stretching | Control | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 64.8 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 |
| Function | 10.1 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 shortening | 28.0 degrees | 25.0 degrees | 26.0 degrees | 20.0 degrees | 24.0 degrees | 24.6 degrees |
| Knee range of motion | 106.0 degrees | 102.0 degrees | 93.0 degrees | 108.0 degrees | 104.0 degrees | 102.6 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 |
| Pain | 6.5 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 symptoms | 33.4 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 Participants | 19 Participants | 18 Participants | 17 Participants | 22 Participants | 98 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 7 Participants | 8 Participants | 3 Participants | 27 Participants |
Adverse events
| Event type | EG000 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 / 29 | 0 / 29 | 0 / 29 | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 | 0 / 29 | 0 / 29 | 0 / 29 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Laser + Stretching | Change From Baseline in Visual Analogue Scale for Pain | 3.2 units on a scale | Standard Deviation 2.1 |
| Placebo Laser + Stretching | Change From Baseline in Visual Analogue Scale for Pain | 3.8 units on a scale | Standard Deviation 2.3 |
| Stretching | Change From Baseline in Visual Analogue Scale for Pain | 3.1 units on a scale | Standard Deviation 2.9 |
| Active Laser | Change From Baseline in Visual Analogue Scale for Pain | 3.3 units on a scale | Standard Deviation 2.2 |
| Control | Change From Baseline in Visual Analogue Scale for Pain | 0.7 units on a scale | Standard Deviation 3 |
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Laser + Stretching | Change From Baseline in Lequesne Functional Questionnaire | 2.5 units on a scale |
| Placebo Laser + Stretching | Change From Baseline in Lequesne Functional Questionnaire | 1.5 units on a scale |
| Stretching | Change From Baseline in Lequesne Functional Questionnaire | 4.0 units on a scale |
| Active Laser | Change From Baseline in Lequesne Functional Questionnaire | 3.5 units on a scale |
| Control | Change From Baseline in Lequesne Functional Questionnaire | 0.0 units on a scale |
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Laser + Stretching | Change From Baseline in Range of Motion of Flexion of the Knee | 7.0 degress |
| Placebo Laser + Stretching | Change From Baseline in Range of Motion of Flexion of the Knee | 10.0 degress |
| Stretching | Change From Baseline in Range of Motion of Flexion of the Knee | 6.0 degress |
| Active Laser | Change From Baseline in Range of Motion of Flexion of the Knee | 10.0 degress |
| Control | Change From Baseline in Range of Motion of Flexion of the Knee | 1.0 degress |
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Laser + Stretching | Change From Baseline in Timed Get Up and Go Test | 2.5 seconds |
| Placebo Laser + Stretching | Change From Baseline in Timed Get Up and Go Test | 3.0 seconds |
| Stretching | Change From Baseline in Timed Get Up and Go Test | 2.6 seconds |
| Active Laser | Change From Baseline in Timed Get Up and Go Test | 3.1 seconds |
| Control | Change From Baseline in Timed Get Up and Go Test | 0.0 seconds |
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Laser + Stretching | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index | 8.0 units on a scale |
| Placebo Laser + Stretching | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index | 11.0 units on a scale |
| Stretching | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index | 13.0 units on a scale |
| Active Laser | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index | 16.0 units on a scale |
| Control | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index | 2.0 units on a scale |