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Completed

NCT Number: NCT03421249

Treatment of Knee Osteoarthrosis Using the Electromagnetic Fields

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.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercises

Other

Muscle strengthening exercises of the hip and knee muscles

Electromagnetic field therapy

Other

Electromagnetic field therapy with Magnetron®

Primary outcomes

  1. Pain

    Time frame: The visual analog pain scale was performed without onset and after 3 months after treatment

    Visual Analog Pain Scale

Sponsors and collaborators

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2018
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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