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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
| Coordenação de Aperfeiçoamento de Pessoal de NÃvel Superior. | OTHER_GOV |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stretching | Experimental | Seven stretching exercises for lower limbs during 24 sessions |
|
| Placebo laser + Stretching | Experimental | application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions |
|
| Active laser + Stretching | Experimental | application of active laser therapy during nine sessions plus stretching exercises during 24 sessions |
|
| Active Laser | Experimental | Application of active laser only during 24 sessions |
|
| Control | No Intervention | Control group that will receive a small book with informations about knee osteoarthritis and postural orientation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Laser | Device | 18 points of application of active laser in the knee (frontal faces, lateral and medial) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and post-intervention, up to 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and post-intervention, up to 11 weeks |
| Change From Baseline in Range of Motion of Flexion of the Knee |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Rubia F Meneses | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Specialized rehabilitation service | Taboão da Serra | São Paulo | 06775-005 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26369333 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stretching | Seven stretching exercises for lower limbs during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions |
| FG001 | 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: 9 points of application of placebo laser per knee (frontal faces, lateral and medial) |
| FG002 | Active Laser + Stretching | application of active laser therapy during nine sessions plus stretching exercises during 24 sessions Active Laser: 9 points of application of active laser per knee (frontal faces, lateral and medial) Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions |
| FG003 | Active Laser | Application of active laser only during 24 sessions Active Laser: 9 points of application of active laser per knee (frontal faces, lateral and medial) |
| FG004 | Control | Control group that will receive a small book with informations about knee osteoarthritis and postural orientation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There was no statistically significant difference between groups at baseline (p> 0.05).
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| ID | Title | Description |
|---|---|---|
| BG000 | Stretching | Seven stretching exercises for lower limbs during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions |
| BG001 | Placebo Laser + Stretching |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and post-intervention, up to 11 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Rubia Ferreira de Meneses | University of Sao Paulo | +55(11)470898-71 | sarah.meneses@usp.br |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D052580 | Muscle Stretching Exercises |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| Stretching exercises | Other | 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions |
|
| placebo laser therapy | Device | 18 points of application of placebo laser in the knee (frontal faces, lateral and medial) |
|
|
Higher values represent better outcomes The assessment will be done in the patient's first evaluation and after each intervention. |
| Baseline and post-intervention, up to 11 weeks |
| 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. | Baseline and post-intervention, up to 11 weeks |
| 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. | Baseline and post-intervention, up to 11 weeks |
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)
| BG002 | 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 |
| BG003 | 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) |
| BG004 | Control | Control group that will receive a small book with informations about knee osteoarthritis and postural orientation. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pain | Scale varies from 0 (no pain) to 10 (worst pain possible). | Mean | Standard Deviation | cm on Visual Analogue Scale (0-10) |
|
| Self-reported symptoms | Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) asses self reported symptoms of pain, function and stiffness. The total scores varies from 0 (no impairment) to 96 (worse outcome). | Mean | Standard Deviation | units on scale WOMAC |
|
| Function | The questionnaire varies from 0 to 24. Higher values represent worse outcome. | Mean | Standard Deviation | units on Lequesne Functional Question. |
|
| Mobility - Timed Get up and Go (TUG) | TUG measures the time a person spends to get up from a chair, walks at the usual speed for 3m, turns, walk back and sit down. | Mean | Standard Deviation | seconds |
|
| Knee range of motion | Median | Inter-Quartile Range | degrees |
|
| Hamstring shortening | Median | Inter-Quartile Range | degrees |
|
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)
| OG002 | Stretching | Seven stretching exercises for lower limbs during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions |
| OG003 | 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) |
| OG004 | Control | Control group that will receive a small book with informations about knee osteoarthritis and postural orientation. |
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and post-intervention, up to 11 weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | degress | Baseline and post-intervention, up to 11 weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and post-intervention, up to 11 weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | seconds | Baseline and post-intervention, up to 11 weeks |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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) | 0 | 29 | 0 | 29 |
| EG002 | Stretching | Seven stretching exercises for lower limbs during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions | 0 | 29 | 0 | 29 |
| EG003 | 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) | 0 | 29 | 0 | 29 |
| EG004 | Control | Control group that will receive a small book with informations about knee osteoarthritis and postural orientation. | 0 | 29 | 0 | 29 |
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| D012216 |
| Rheumatic Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |