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Treatment of Knee Osteoarthrosis Using the Electromagnetic Fields

Primary Purpose

Knee Osteoarthritis, Knee Arthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercises
Electromagnetic field therapy
Sponsored by
Faculdade de Ciências Médicas da Santa Casa de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Active Comparator

    Arm Label

    Group A - Intervention

    Group B - exercises

    Group C - Placebo

    Group D - Apparatus

    Arm Description

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

    Performed exercises to strengthen the hip and knee muscles

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

    Only use electromagnetic field therapy with the coplanar Magnetron® technique

    Outcomes

    Primary Outcome Measures

    Pain
    Visual Analog Pain Scale

    Secondary Outcome Measures

    Full Information

    First Posted
    January 8, 2018
    Last Updated
    January 29, 2018
    Sponsor
    Faculdade de Ciências Médicas da Santa Casa de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03421249
    Brief Title
    Treatment of Knee Osteoarthrosis Using the Electromagnetic Fields
    Official Title
    Treatment of Knee Osteoarthrosis Using the Electromagnetic Fields: Blinded and Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2016 (Actual)
    Primary Completion Date
    January 1, 2017 (Actual)
    Study Completion Date
    December 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Faculdade de Ciências Médicas da Santa Casa de São Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis, Knee Arthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A - Intervention
    Arm Type
    Active Comparator
    Arm Description
    Submitted to knee and hip muscle strengthening exercises and electromagnetic field therapy with Magnetron ® (Meditea - ARG) using the coplanar technique
    Arm Title
    Group B - exercises
    Arm Type
    Active Comparator
    Arm Description
    Performed exercises to strengthen the hip and knee muscles
    Arm Title
    Group C - Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Performed hip and knee strengthening exercises and electromagnetic field therapy with the coplanar Magnetron® technique, but with the device switched off
    Arm Title
    Group D - Apparatus
    Arm Type
    Active Comparator
    Arm Description
    Only use electromagnetic field therapy with the coplanar Magnetron® technique
    Intervention Type
    Other
    Intervention Name(s)
    Exercises
    Intervention Description
    Muscle strengthening exercises of the hip and knee muscles
    Intervention Type
    Other
    Intervention Name(s)
    Electromagnetic field therapy
    Intervention Description
    Electromagnetic field therapy with Magnetron®
    Primary Outcome Measure Information:
    Title
    Pain
    Description
    Visual Analog Pain Scale
    Time Frame
    The visual analog pain scale was performed without onset and after 3 months after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28770628
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

    Treatment of Knee Osteoarthrosis Using the Electromagnetic Fields

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