Treatment of Knee Osteoarthrosis Using the Electromagnetic Fields

NCT03421249 | Completed DMC

• 1 other identifier: Hugo Cesar
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis; Knee Arthritis

Outcome Measures

Primary Outcomes (1)

• Pain

  Visual Analog Pain Scale

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

Study Arms (4)

Group A - Intervention

ACTIVE COMPARATOR

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

Other: Exercises; Other: Electromagnetic field therapy

Group B - exercises

ACTIVE COMPARATOR

Performed exercises to strengthen the hip and knee muscles

Other: Exercises

Group C - Placebo

PLACEBO COMPARATOR

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

Group D - Apparatus

ACTIVE COMPARATOR

Only use electromagnetic field therapy with the coplanar Magnetron® technique

Other: Electromagnetic field therapy

Interventions

Exercises OTHER

Muscle strengthening exercises of the hip and knee muscles

Group A - Intervention; Group B - exercises

Electromagnetic field therapy OTHER

Electromagnetic field therapy with Magnetron®

Group A - Intervention; Group C - Placebo; Group D - Apparatus

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 28770628 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise; Magnetic Field Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Diego Galace de Freitas

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: February 5, 2018
• Study Start: May 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 5, 2018

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share