Osteo Arthritis KneeNCT04788706
LLLT and Russian Electrical Stimulation in Osteoarthritis
A study testing Low level Laser Therapy and Russian electrical stimulation and Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation in people with Osteo Arthritis Knee, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Objectives: To investigate the effect of low-level laser therapy (LLLT) application combined with Russian Electrical Stimulation on pain, mobility, functionality, range of motion, muscular strength, and activity in patients with osteoarthritis of the knee. Design: Randomized controlled double-blind study. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Low level Laser Therapy and Russian electrical stimulation and Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2019to 1 Dec 2020
- Phase
- Interventional
- 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
- levels 2-4 according to Kellgren-Lawrence grade
- aged 50-75 years
- both genders
- have knee pain and functional disability for at least three months
- according to the criteria of the American College for Rheumatology.
Who cannot join
- cancer, diabetes, symptomatic hip osteoarthritis, or used antidepressants, anti-inflammatory medications or anxiolytics during six months prior to enrolment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Physical Therapy, Speech and Occupational Therapy of University of São Paulo
São Paulo, 05360-160
About this study
Official title: Efficacy of Low-level Laser Therapy Associated With Russian Electrical Stimulation in Knee Osteoarthritis: a Randomized Controlled Double-blind Study
Objectives: To investigate the effect of low-level laser therapy (LLLT) application combined with Russian Electrical Stimulation on pain, mobility, functionality, range of motion, muscular strength, and activity in patients with osteoarthritis of the knee.
Design: Randomized controlled double-blind study. Setting: Specialist Rehabilitation Services.
Read the detailed description
ABSTRACT Objectives: To investigate the effect of low-level laser therapy (LLLT) application combined with Russian Electrical Stimulation on pain, mobility, functionality, range of motion, muscular strength, and activity in patients with osteoarthritis of the knee.
Design: Randomized controlled double-blind study. Setting: Specialist Rehabilitation Services. Participants: Eighty participants with knee osteoarthritis were randomized. Intervention: Participants were randomized into four groups: Group I (n=20; LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation), Group II (n=20; Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation), Group III (n=20; LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation), Group IV (n=20; Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation). The groups treated with LLLT received treatments with invisible infrared laser (904 nm, 3 Joules/point). The Placebo groups received identical treatment, but the infrared laser output was disabled. The sessions occurred three times a week.
Main outcome measures: The primary outcome was the change in knee pain and functionality (Lequesne). Secondary outcomes included change in mobility (8 meters and Timed Up and Go test), range of motion (goniometer), muscular strength (dynamometer), activity (Western Ontario and McMaster Universities Osteoarthritis questionnaire) and medication intake.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Low level Laser Therapy and Russian electrical stimulation, Placebo Laser and Russian electrical stimulation, Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation, Placebo Laser and Placebo Laser plus Russian electrical stimulation
- Keywords
- low level laser therapy, Russian electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level Laser Therapy and Russian electrical stimulationOther
LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation
Placebo Laser and Russian electrical stimulationOther
Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation
Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulationOther
LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation
Placebo Laser and Placebo Laser plus Russian electrical stimulationOther
Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation Receives: Other: Low level Laser Therapy and Russian electrical stimulation |
| Group II | Placebo comparator | Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation Receives: Other: Placebo Laser and Russian electrical stimulation |
| Group III | Active comparator | LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation Receives: Other: Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation |
| Group IV | Placebo comparator | Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation Receives: Other: Placebo Laser and Placebo Laser plus Russian electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
numeric pain rating scale (0-10) with a minimal clinically important change of two points
Measured: 6 months from baseline (follow up)
Functionality
Was measured using the Lequesne questionnaire (11 questions about pain, discomfort and function). Scores range from 0 to 24 (from 'no' to 'extremely severe' dysfunction).
Measured: 6 months from baseline (follow up)
Secondary outcomes (5)
Medication intake
Paracetamol
Measured: 6 months from baseline (follow up)
Mobility and balance
were evaluated by the Timed Up and Go (TUG) test19 and the 8-meter walk test.20 The TUG test, a measure of functional mobility, quantifies in seconds the time that the individual needs to stand up from a chair, walk 3m, turn back toward the chair and sit down again. The 8-meter walk test measures the time and number of steps required for a person to walk 8m.
Measured: 6 months from baseline (follow up)
Range of motion of the knees
was measured with a universal goniometer (AESCULAP).
Measured: 6 months from baseline (follow up)
Muscular strength
was estimated at maximal isometric force for the quadriceps, using a portable dynamometer (Lafayette, USA). Under stabilized conditions, patients, sitting with knees flexed at 60 (measured by a goniometer),21 were asked to extend the legs as far as they could. Three trials were conducted, and the mean value was obtained.
Measured: 6 months from baseline (follow up)
Activity
was measured using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) questionnaire,22 which is self-administered and measures pain, frozen joints and physical activity. Increased scores suggest decreased activity.
Measured: 6 months from baseline (follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Jan 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia P Alfredo, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788706
- Sponsor's protocol ID
- 0775/08
- Status last verified
- Dec 2020
- First submitted
- 29 Dec 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results obtained with the study will be made available to participants at the end of the study. These data will be published in articles, so that the anonymity of the participants is guaranteed. All subjects who agreed to participate in the study signed a free and informed consent form and authorized the dissemination of the study results in articles or abstracts presented at scientific congresses.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low-level Laser Therapy Associated With Russian Electrical Stimulation in Knee Osteoarthritis: a Randomized Controlled Double-blind Study
- ClinicalTrials.gov ID
- NCT04788706
- Acronym / sponsor ID
- 0775/08
- Conditions
- Osteo Arthritis Knee
- Keywords
- low level laser therapy, Russian electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 9 Mar 2021 (actual)
- 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.
Objectives: To investigate the effect of low-level laser therapy (LLLT) application combined with Russian Electrical Stimulation on pain, mobility, functionality, range of motion, muscular strength, and activity in patients with osteoarthritis of the knee.
Design: Randomized controlled double-blind study. Setting: Specialist Rehabilitation Services.
Detailed description
ABSTRACT Objectives: To investigate the effect of low-level laser therapy (LLLT) application combined with Russian Electrical Stimulation on pain, mobility, functionality, range of motion, muscular strength, and activity in patients with osteoarthritis of the knee.
Design: Randomized controlled double-blind study. Setting: Specialist Rehabilitation Services. Participants: Eighty participants with knee osteoarthritis were randomized. Intervention: Participants were randomized into four groups: Group I (n=20; LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation), Group II (n=20; Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation), Group III (n=20; LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation), Group IV (n=20; Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation). The groups treated with LLLT received treatments with invisible infrared laser (904 nm, 3 Joules/point). The Placebo groups received identical treatment, but the infrared laser output was disabled. The sessions occurred three times a week.
Main outcome measures: The primary outcome was the change in knee pain and functionality (Lequesne). Secondary outcomes included change in mobility (8 meters and Timed Up and Go test), range of motion (goniometer), muscular strength (dynamometer), activity (Western Ontario and McMaster Universities Osteoarthritis questionnaire) and medication intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Other: Low level Laser Therapy and Russian electrical stimulationLLLT over three weeks followed by an eight-week receiving Russian electrical stimulation |
| Group II | Placebo comparator | Other: Placebo Laser and Russian electrical stimulationPlacebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation |
| Group III | Active comparator | Other: Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulationLLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation |
| Group IV | Placebo comparator | Other: Placebo Laser and Placebo Laser plus Russian electrical stimulationPlacebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- levels 2-4 according to Kellgren-Lawrence grade
- aged 50-75 years
- both genders
- have knee pain and functional disability for at least three months
- according to the criteria of the American College for Rheumatology.
Key exclusion criteria (1 listed)
- cancer, diabetes, symptomatic hip osteoarthritis, or used antidepressants, anti-inflammatory medications or anxiolytics during six months prior to enrolment.
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 |
|---|---|---|
| Low level Laser Therapy and Russian electrical stimulationLLLT over three weeks followed by an eight-week receiving Russian electrical stimulation | Other | Group I |
| Placebo Laser and Russian electrical stimulationPlacebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation | Other | Group II |
| Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulationLLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation | Other | Group III |
| Placebo Laser and Placebo Laser plus Russian electrical stimulationPlacebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation | Other | Group IV |
Primary outcome
Pain intensity
Time frame: 6 months from baseline (follow up)
numeric pain rating scale (0-10) with a minimal clinically important change of two points
Functionality
Time frame: 6 months from baseline (follow up)
Was measured using the Lequesne questionnaire (11 questions about pain, discomfort and function). Scores range from 0 to 24 (from 'no' to 'extremely severe' dysfunction).
5 secondary outcomes
Medication intake
Time frame: 6 months from baseline (follow up)
Mobility and balance
Time frame: 6 months from baseline (follow up)
Range of motion of the knees
Time frame: 6 months from baseline (follow up)
Muscular strength
Time frame: 6 months from baseline (follow up)
Activity
Time frame: 6 months from baseline (follow up)
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 9 Mar 2021.
- Individual participant dataSharing planned: No. The results obtained with the study will be made available to participants at the end of the study. These data will be published in articles, so that the anonymity of the participants is guaranteed. All subjects who agreed to participate in the study signed a free and informed consent form and authorized the dissemination of the study results in articles or abstracts presented at scientific congresses.
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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.
Patricia P Alfredo, PhD 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 Low level Laser Therapy and Russian electrical stimulation and Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation in people with Osteo Arthritis 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 5 inclusion and 1 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 9 Mar 2021. 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.
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?
Pain intensity (time frame: 6 months from baseline (follow up)). The study lists 2 primary outcomes in all. 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 9 Mar 2021.