Treatment of Knee Osteoarthrosis Using the Electromagnetic Fields

Treatment of Knee Osteoarthrosis Using the Electromagnetic Fields: Blinded and Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Knee Arthritis
• Intervention / Treatment: Other: Exercises; Other: Electromagnetic field therapy

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A - Intervention; Submitted to knee and hip muscle strengthening exercises and electromagnetic field therapy with Magnetron ® (Meditea - ARG) using the coplanar technique	Other: Exercises; Muscle strengthening exercises of the hip and knee muscles; Other: Electromagnetic field therapy; Electromagnetic field therapy with Magnetron®
Active Comparator: Group B - exercises; Performed exercises to strengthen the hip and knee muscles	Other: Exercises; Muscle strengthening exercises of the hip and knee muscles
Placebo Comparator: Group C - Placebo; Performed hip and knee strengthening exercises and electromagnetic field therapy with the coplanar Magnetron® technique, but with the device switched off	Other: Electromagnetic field therapy; Electromagnetic field therapy with Magnetron®
Active Comparator: Group D - Apparatus; Only use electromagnetic field therapy with the coplanar Magnetron® technique	Other: Electromagnetic field therapy; Electromagnetic field therapy with Magnetron®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Visual Analog Pain Scale	The visual analog pain scale was performed without onset and after 3 months after treatment

Collaborators and Investigators

• Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Hugo Cesar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No