Treatment of Knee Osteoarthrosis Using the Electromagnetic Fields

NCT ID: NCT03421249

Last Updated: 2018-02-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2017-12-01

Brief Summary

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This study is a randomized controlled clinical trial using a blind evaluator. Fifty-one volunteers were selected from 50 years to 70 years, obeying the following criteria: diagnosis of knee OA grade II and III through the radiographic classification of Kellgreen and Lawrence 1955, Body mass index (BMI) less than 40 kg / m², volunteers should have had knee pain for at least six months. All are from the Rehabilitation Sector of Santa Casa de Misericórdia de São Paulo (ISCMSP). The subjects were evaluated through a questionnaire developed by the authors of the study (Annex I), the Visual Analogue Scale (EVA) (Annex II), then applied to the Lower Extremity Functional Scale LEFS (Appendix III) and the Activities of daily living scale ADLs (Annex IV). In addition, the evaluation of muscular strength was through dynamometry using the Lafayete dynamometer model 01163, which was performed by a blind evaluator regarding the group that will belong to each candidate. The muscles tested were: quadriceps, ischiostibial and gluteus maximus. The randomization was through 60 brown envelopes divided into A, B, C and D, designating the randomness of the sample.

In addition to the initial evaluation, an evaluation was performed at the end of the tenth session and after 3 months of treatment.

The volunteers underwent a five-week treatment program, totaling 10 sessions, divided into four groups, group A - Intervention (INT) underwent knee and hip muscle strengthening exercises and electromagnetic field therapy with (Meditea - ARG) using the coplanar technique, group B - Exercises (EXE) carried out exercises to strengthen the hip and knee muscles in the C - Placebo group (PLA). hip and knee and electromagnetic field therapy with the Magnetron® coplanar technique, but with the device switched off and group D - Apparatus (APA) only use electromagnetic field therapy with the magnetron® coplanar technique. In the present study, there were no significant differences between groups regarding pain, function and muscle strength. However, group A obtained better results in the evaluated criteria, tending that the combination PEMF and exercises, is an indicated treatment for OA knee.

Detailed Description

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Conditions

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Knee Osteoarthritis Knee Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group A - Intervention

Submitted to knee and hip muscle strengthening exercises and electromagnetic field therapy with Magnetron ® (Meditea - ARG) using the coplanar technique

Group Type ACTIVE_COMPARATOR

Exercises

Intervention Type OTHER

Muscle strengthening exercises of the hip and knee muscles

Electromagnetic field therapy

Intervention Type OTHER

Electromagnetic field therapy with Magnetron®

Group B - exercises

Performed exercises to strengthen the hip and knee muscles

Group Type ACTIVE_COMPARATOR

Exercises

Intervention Type OTHER

Muscle strengthening exercises of the hip and knee muscles

Group C - Placebo

Performed hip and knee strengthening exercises and electromagnetic field therapy with the coplanar Magnetron® technique, but with the device switched off

Group Type PLACEBO_COMPARATOR

Electromagnetic field therapy

Intervention Type OTHER

Electromagnetic field therapy with Magnetron®

Group D - Apparatus

Only use electromagnetic field therapy with the coplanar Magnetron® technique

Group Type ACTIVE_COMPARATOR

Electromagnetic field therapy

Intervention Type OTHER

Electromagnetic field therapy with Magnetron®

Interventions

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Exercises

Muscle strengthening exercises of the hip and knee muscles

Intervention Type OTHER

Electromagnetic field therapy

Electromagnetic field therapy with Magnetron®

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosis of knee OA grade II and III
* Body mass index (BMI) of less than 40 kg / m²
* knee pain for at least six months

Exclusion Criteria

* Severe OA above grade 3
* previous physical therapy for at least 6 months,
* any other affection of the lower limbs (LLL) and lumbar spine,
* obesity (BMI\> 40),
* patients with cardiovascular, metabolic, neurological, oncological or history of knee surgery.
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculdade de Ciências Médicas da Santa Casa de São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Diego Galace de Freitas

Principal Investigator Diego Galace de Freitas

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Added MAN, Added C, Kasawara KT, Rotta VP, de Freitas DG. Effects of a Knee Brace With a Patellar Hole Versus Without a Patellar Hole in Patients With Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial. Eval Health Prof. 2018 Dec;41(4):512-523. doi: 10.1177/0163278717714307. Epub 2017 Jun 30.

Reference Type RESULT
PMID: 28770628 (View on PubMed)

Other Identifiers

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Hugo Cesar

Identifier Type: -

Identifier Source: org_study_id

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