Osteoarthritis, KneeNCT01738737
Low-level Laser Therapy and Static Stretching in Knee Osteoarthritis.
A study testing Active Laser and Stretching exercises in people with Osteoarthritis, Knee, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Active Laser and Stretching exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Specialized rehabilitation service
Taboão da Serra, São Paulo, 06775-005
About this study
Official title: Effect of Low-level Laser Therapy (904 nm) and Static Stretching in Patients With Knee Osteoarthritis: Randomised Controlled Trial.
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Active Laser, Stretching exercises, placebo laser therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active LaserDevice
Also called LaserPulse (904nm) class II IBRAMED
18 points of application of active laser in the knee (frontal faces, lateral and medial)
Stretching exercisesOther
7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions
placebo laser therapyDevice
Also called LaserPulse class II IBRAMED
18 points of application of placebo laser in the knee (frontal faces, lateral and medial)
| Study group | Role | What they receive |
|---|---|---|
| Stretching | Experimental | Seven stretching exercises for lower limbs during 24 sessions Receives: Other: Stretching exercises |
| Placebo laser + Stretching | Experimental | application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions Receives: Other: Stretching exercises; Device: placebo laser therapy |
| Active laser + Stretching | Experimental | application of active laser therapy during nine sessions plus stretching exercises during 24 sessions Receives: Device: Active Laser; Other: Stretching exercises |
| Active Laser | Experimental | Application of active laser only during 24 sessions Receives: Device: Active Laser |
| Control | No intervention | Control group that will receive a small book with informations about knee osteoarthritis and postural orientation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and post-intervention, up to 11 weeks
Secondary outcomes (4)
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.
Measured: Baseline and post-intervention, up to 11 weeks
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.
Measured: 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.
Measured: 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.
Measured: Baseline and post-intervention, up to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Sarah Rubia F Meneses, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738737
- Sponsor's protocol ID
- CAPPESQ 455/11
- Status last verified
- Sep 2015
- First submitted
- 28 Aug 2012
- Last updated
- 10 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26369333
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-level Laser Therapy (904 nm) and Static Stretching in Patients With Knee Osteoarthritis: Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT01738737
- Acronym / sponsor ID
- CAPPESQ 455/11
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- 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
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Posted 10 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Stretching | Experimental | Other: Stretching exercisesSeven stretching exercises for lower limbs during 24 sessions |
| Placebo laser + Stretching | Experimental | Other: Stretching exercises, Device: placebo laser therapyapplication of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions |
| Active laser + Stretching | Experimental | Device: Active Laser, Other: Stretching exercisesapplication of active laser therapy during nine sessions plus stretching exercises during 24 sessions |
| Active Laser | Experimental | Device: Active LaserApplication 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active LaserAlso: LaserPulse (904nm) class II IBRAMED18 points of application of active laser in the knee (frontal faces, lateral and medial) | Device | Active Laser, Active laser + Stretching |
| Stretching exercises7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions | Other | Active laser + Stretching, Placebo laser + Stretching, Stretching |
| placebo laser therapyAlso: LaserPulse class II IBRAMED18 points of application of placebo laser in the knee (frontal faces, lateral and medial) | Device | Placebo laser + Stretching |
Primary outcome
Change From Baseline in Visual Analogue Scale for Pain
Time frame: 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.
4 secondary outcomes
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Baseline and post-intervention, up to 11 weeks
Change From Baseline in Range of Motion of Flexion of the Knee
Time frame: Baseline and post-intervention, up to 11 weeks
Change From Baseline in Lequesne Functional Questionnaire
Time frame: Baseline and post-intervention, up to 11 weeks
Change From Baseline in Timed Get Up and Go Test
Time frame: Baseline and post-intervention, up to 11 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26369333Ferreira 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Rubia F Meneses principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Laser and Stretching exercises in people with Osteoarthritis, Knee, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Visual Analogue Scale for Pain (time frame: Baseline and post-intervention, up to 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01738737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015; AzTrials last refreshed its copy on 6 Nov 2026.