LLLT and Russian Electrical Stimulation in Osteoarthritis
NCT ID: NCT04788706
Last Updated: 2021-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2019-01-01
2020-12-01
Brief Summary
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Design: Randomized controlled double-blind study. Setting: Specialist Rehabilitation Services.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group I
LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation
Low level Laser Therapy and Russian electrical stimulation
LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation
Group II
Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation
Placebo Laser and Russian electrical stimulation
Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation
Group III
LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation
Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation
LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation
Group IV
Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation
Placebo Laser and Placebo Laser plus Russian electrical stimulation
Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation
Interventions
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Low level Laser Therapy and Russian electrical stimulation
LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation
Placebo Laser and Russian electrical stimulation
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 stimulation
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 stimulation
Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation
Eligibility Criteria
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Inclusion Criteria
2. aged 50-75 years
3. both genders
4. have knee pain and functional disability for at least three months
5. according to the criteria of the American College for Rheumatology.
Exclusion Criteria
50 Years
75 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Principal Investigators
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Patricia P Alfredo, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Department of Physical Therapy, Speech and Occupational Therapy of University of São Paulo
São Paulo, , Brazil
Countries
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Other Identifiers
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0775/08
Identifier Type: -
Identifier Source: org_study_id
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