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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
RBR-7gkwdj |
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Date of registration:
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09/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Laser therapy in patients with knee artrosis
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Scientific title:
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Laser therapy in patients with knee osteoarthritis |
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Date of first enrolment:
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10/03/2013 |
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Target sample size:
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Recruitment status: |
Recruitment completed |
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URL:
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http://ensaiosclinicos.gov.br/rg/RBR-7gkwdj |
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Study type:
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Intervention |
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Study design:
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Clinical efficacy trial, randomized, parallel, controlled, double blind, two-arm.
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Carlos Eduardo
Pinfildi |
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Address:
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Rua Silva Jardim, 136
11015-020
Santos
Brazil |
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Telephone:
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+55(13)38783700 |
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Email:
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cepinfildi@hotmail.com |
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Affiliation:
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Universidade Federal de São Paulo |
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Name:
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André Cabral
Sardim |
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Address:
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Rua Silva Jardim, 136
11015-020
Santos
Brazil |
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Telephone:
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+55(13)38783700 |
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Email:
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asardim@gmail.com |
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Affiliation:
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Universidade Federal de São Paulo |
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Key inclusion & exclusion criteria
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Inclusion criteria: Age over 50 year, knee osteoartritis unilateral or bilateral within 2 years with pain in following tasks: up and down stairs, kneeling, seat and down up, running and standing up for 2 minutes, Kellgren-Laurence grade II or III and BMI<35
Exclusion criteria: Diabetes mellitus, untreated hipertension blood pressure, previous knee replacement, neurologics deficits, neuropathics disorders, physically active (more than 2 times a week), alcoholic and cancer diagnosis
Age minimum:
50Y
Age maximum:
100Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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C05.550.114.606.500
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Musculoskeletal diseases, Gonarthrosis [arthrosis of knee], knee osteoarthritis
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Intervention(s)
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E02.774
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E07.230.460
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Other
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Device
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Group 1: Patients underwent an exercises treatment program (muscles stretching, strenght muscles and proprioception) and placebo.
Group 2: Patients underwent an exercises treatment program (muscles stretching, strenght muscles and proprioception) and low level laser therapy with cluster 7 diodes wavelenght 630nm and 7 diodes wavelenght 850 nm with outpower 100mW each diode,energy 4J, energy per point 56J and total energy 168J each limb. Time of exposure will be 40 seconds per point and continuous wave. The groups will receive treatment for 12 weeks during 3 times a week.
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E02.594.540
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G11.427.590.530.698.277
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Primary Outcome(s)
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Decreased pain assessed by visual analogue scale of pain, considering a variation of at least 3 points in pre and post treatment comparison.
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Secondary Outcome(s)
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Increased functionality of the individual verified by means of the SF-36 and Womac, considering a variation of at least 10% between the pre and post intervention; increase in the flexibility of the individual through the evaluation of range of motion with a goniometer, considering a variation of at least 10% between the pre and post intervention; improves the balance of the individual verified with the Berg balance scale, considering a variation of at least 10% between the pre and post intervention; increased strength of the quadriceps checked with hand dynamometer, using the protocol described by the manufacturer, considering a variation of at least 10% between the pre and post intervention.
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Source(s) of Monetary Support
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Universidade Federal de São Paulo
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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