OsteoarthritisPhase 2NCT01306435
Low Power Laser and Exercise in Osteoarthritis of the Knee: a Randomized Clinical Trial
A Phase 2 study testing Laser in people with Osteoarthritis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Indroduction: Knee osteoarthritis (OA) is a painful condition causing disability, weakness and poor quality of live. The results are very consistent about the benefits of laser and exercises to improve pain and function in subjects with knee osteoarthritis Objectives: To investigate the effects of Low Power Laser… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Laser
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2009to Feb 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Diagnoses of osteoarthritis
- Knee pain
- Functional reduction in the last three months
- Grade 2-4 OA
- Fulfilled at least one of the classification criteria of the American College of Rheumatology
Who cannot join
- Cancer
- Diabetes mellitus
- Symptomatic hip OA
- Antidepressants
- Anti-inflammatory steroidal and nonsteroidal or tranquilizers in the last six months and throughout the treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Low Power Laser Associated With Exercises in Osteoartite Knee: Randomized Clinical Trial, Double-blind, Controlled
Indroduction: Knee osteoarthritis (OA) is a painful condition causing disability, weakness and poor quality of live. The results are very consistent about the benefits of laser and exercises to improve pain and function in subjects with knee osteoarthritis Objectives: To investigate the effects of Low Power Laser (LBP) associated with exercise in pain, function, range of motion, muscle strength and quality of life of patients with knee osteoarthritis.
Methods: Forty patients of both sexes aged between 50 and 75 years with knee osteoarthritis (grade 2-4) were randomized into two groups: Laser-LBP-active dose of 3J more exercises and Group Placebo-LBP- placebo and exercise. Were evaluated for pain, function, range of motion, muscle strength and quality of life on three occasions: before starting treatment (evaluation 1), 3 weeks after laser application (evaluation 2) and 8 weeks after completion of exercise (evaluation 3). There were 33 physical therapy sessions three times a week, on March 1 and the laser was applied in the other, only the exercises.
Read the detailed description
Pain: Pain intensity was measured with the Visual Analogue Scale (VAS) which is a straight 10 cm long devoid of numbers, in which there is only an indication of the extreme left of "no pain" and extreme right to "unbearable pain". The higher the score, the greater the pain.
Feature: Survey conducted by Lequesne, which is an index composed of 11 questions about pain, discomfort and function. The scores range from 0 to 24 (without affecting the extremely severe, respectively), the higher the score, the greater the impairment.
Range of motion (ROM): ADM flexion and knee extension was measured using a universal goniometer (AESCULAP) with the patient prone second methodology Marques.
Muscular Strength: To assess the maximal isometric strength of the quadriceps muscle was used Dynamometer model Lafayette ® Portable (USA), while seated at 60 ° of knee flexion and this gradation was controlled with a goniometer. Patients remained seated on the stretcher and held steady with thigh extension strength, the dynamometer being maintained in the distal leg. Three measurements were taken, and the mean value.
Quality of Life: The Questionnaire was used Western Ontario and McMaster Universities Osteoarthritis (WOMAC)a self-assessment that evaluates pain, stiffness and physical activity. The higher the score, the greater the impact of OA on quality of life.
- Conditions
- Osteoarthritis
- Being tested
- Laser, Placebo Laser
- Keywords
- Osteoarthritis, Low Power Laser Therapy, Exercise, Knee
- Medical subject headings
- Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserOther
Also called LOW POWER LASER
3-week treatment with three Laser sessions per week
Placebo LaserOther
Also called PLACEBO LOW POWER LASER
3-week treatment with three Placebo Laser sessions per week
| Study group | Role | What they receive |
|---|---|---|
| Laser Group | Experimental | Not described Receives: Other: Laser |
| Placebo Group | Placebo comparator | Not described Receives: Other: Placebo Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in VAS at 3 and 8 weeks
In the VAS the subject marks the intensity of its pain in a centimeter horizontal line
Measured: baseline, 3 and 8 weeks
Secondary outcomes (4)
Change from baseline in Lequesne at 3 an 8 weeks
Lequesne index is a composite of 11 questions about pain, discomfort and function. The scores range from 0 to 24 (without affecting the extremely severe, respectively), the higher the score, the greater the impairment.
Measured: baseline, 3 and 8 weeks
Change from baseline in range of motion
ADM flexion and knee extension was measured using a universal goniometer (AESCULAP) with the patient prone
Measured: baseline, 3 and 8 weeks
Change from baseline in Muscular Strength at 3 and 8 weeks
To assess the maximal isometric strength of the quadriceps muscle was used Dynamometer model Lafayette ® Portable (USA), while seated at 60 ° of knee flexion and this gradation was controlled with a goniometer. Patients remained seated on the stretcher and held steady with thigh extension strength, the dynamometer being maintained in the distal leg. Three measurements were taken, and the mean value
Measured: baseline, 3 and 8 weeks
Change from baseline in Quality of Life at 3 and 8 weeks
The Questionnaire was used Western Ontario and McMaster Universities Osteoarthritis (WOMAC) a self-assessment that evaluates pain, stiffness and physical activity. The higher the score, the greater the impact of OA on quality of life.
Measured: baseline, 3 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Patrícia P Alfredo, MS, Principal investigator, Faculty of Medicine of the University of São PauloAmélia P Marques, PhD, Study director, Faculty of Medicine of the University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306435
- Sponsor's protocol ID
- 077508
- Status last verified
- Feb 2011
- First submitted
- 23 Feb 2011
- Last updated
- 1 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Power Laser Associated With Exercises in Osteoartite Knee: Randomized Clinical Trial, Double-blind, Controlled
- ClinicalTrials.gov ID
- NCT01306435
- Acronym / sponsor ID
- 077508
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Low Power Laser Therapy, Exercise, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Indroduction: Knee osteoarthritis (OA) is a painful condition causing disability, weakness and poor quality of live. The results are very consistent about the benefits of laser and exercises to improve pain and function in subjects with knee osteoarthritis Objectives: To investigate the effects of Low Power Laser (LBP) associated with exercise in pain, function, range of motion, muscle strength and quality of life of patients with knee osteoarthritis.
Methods: Forty patients of both sexes aged between 50 and 75 years with knee osteoarthritis (grade 2-4) were randomized into two groups: Laser-LBP-active dose of 3J more exercises and Group Placebo-LBP- placebo and exercise. Were evaluated for pain, function, range of motion, muscle strength and quality of life on three occasions: before starting treatment (evaluation 1), 3 weeks after laser application (evaluation 2) and 8 weeks after completion of exercise (evaluation 3). There were 33 physical therapy sessions three times a week, on March 1 and the laser was applied in the other, only the exercises.
Detailed description
Pain: Pain intensity was measured with the Visual Analogue Scale (VAS) which is a straight 10 cm long devoid of numbers, in which there is only an indication of the extreme left of "no pain" and extreme right to "unbearable pain". The higher the score, the greater the pain.
Feature: Survey conducted by Lequesne, which is an index composed of 11 questions about pain, discomfort and function. The scores range from 0 to 24 (without affecting the extremely severe, respectively), the higher the score, the greater the impairment.
Range of motion (ROM): ADM flexion and knee extension was measured using a universal goniometer (AESCULAP) with the patient prone second methodology Marques.
Muscular Strength: To assess the maximal isometric strength of the quadriceps muscle was used Dynamometer model Lafayette ® Portable (USA), while seated at 60 ° of knee flexion and this gradation was controlled with a goniometer. Patients remained seated on the stretcher and held steady with thigh extension strength, the dynamometer being maintained in the distal leg. Three measurements were taken, and the mean value.
Quality of Life: The Questionnaire was used Western Ontario and McMaster Universities Osteoarthritis (WOMAC)a self-assessment that evaluates pain, stiffness and physical activity. The higher the score, the greater the impact of OA on quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Group | Experimental | Other: Laser |
| Placebo Group | Placebo comparator | Other: Placebo Laser |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnoses of osteoarthritis
- Knee pain
- Functional reduction in the last three months
- Grade 2-4 OA
- Fulfilled at least one of the classification criteria of the American College of Rheumatology
Key exclusion criteria (5 listed)
- Cancer
- Diabetes mellitus
- Symptomatic hip OA
- Antidepressants
- Anti-inflammatory steroidal and nonsteroidal or tranquilizers in the last six months and throughout the treatment
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 |
|---|---|---|
| LaserAlso: LOW POWER LASER3-week treatment with three Laser sessions per week | Other | Laser Group |
| Placebo LaserAlso: PLACEBO LOW POWER LASER3-week treatment with three Placebo Laser sessions per week | Other | Placebo Group |
Primary outcome
Change from baseline in VAS at 3 and 8 weeks
Time frame: baseline, 3 and 8 weeks
In the VAS the subject marks the intensity of its pain in a centimeter horizontal line
4 secondary outcomes
Change from baseline in Lequesne at 3 an 8 weeks
Time frame: baseline, 3 and 8 weeks
Change from baseline in range of motion
Time frame: baseline, 3 and 8 weeks
Change from baseline in Muscular Strength at 3 and 8 weeks
Time frame: baseline, 3 and 8 weeks
Change from baseline in Quality of Life at 3 and 8 weeks
Time frame: baseline, 3 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2011.
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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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.
Patrícia P Alfredo, MS principal investigator
Faculty of Medicine of the University of São Paulo
Amélia P Marques, PhD study director
Faculty of Medicine of the University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laser in people with Osteoarthritis, 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 5 inclusion and 5 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 1 Mar 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 VAS at 3 and 8 weeks (time frame: baseline, 3 and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2011.